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1. Indomethacin with or without prophylactic pancreatic stent placement to prevent pancreatitis after ERCP: a randomised non-inferiority trial

Author

Elmunzer, B. Joseph, Foster, Lydia D., Serrano, Jose, Coté, Gregory A., Edmundowicz, Steven A., Wani, Sachin, Shah, Raj, Bang, Ji Young, Varadarajulu, Shyam, Singh, Vikesh K., Khashab, Mouen, Kwon, Richard S., Scheiman, James M., Willingham, Field F., Keilin, Steven A., Papachristou, Georgios I., Chak, Amitabh, Slivka, Adam, Mullady, Daniel, Kushnir, Vladimir, Buxbaum, James, Keswani, Rajesh, Gardner, Timothy B., Forbes, Nauzer, Rastogi, Amit, Ross, Andrew, Law, Joanna, Yachimski, Patrick, Chen, Yen-I, Barkun, Alan, Smith, Zachary L., Petersen, Bret, Wang, Andrew Y., Saltzman, John R., Spitzer, Rebecca L., Ordiah, Collins, Spino, Cathie, Higgins, Peter D.R., Forster, Erin, Moran, Robert A., Brauer, Brian, Wamsteker, Erik J., Cai, Qiang, Qayed, Emad, Groce, Royce, Krishna, Somashekar G., Faulx, Ashley, Glessing, Brooke, Rabinovitz, Mordechai, Lang, Gabriel, Aadam, Aziz, Komanduri, Srinadh, Adler, Jefferey, Gordon, Stuart, Mohamed, Rachid, Olyaee, Mojtaba, Wood-Williams, April, Depue Brewbaker, Emily K., Thornhill, Andre, Gould, Mariana, Clasen, Kristen, Olsen, Jama, Simon, Violette C., Kamal, Ayesha, Volk, Sarah L., Merchant, Ambreen A., Lahooti, Ali, Furey, Nancy, Anderson, Gulsum, Hollander, Thomas, Vazquez, Alejandro, Li, Thomas Y., Hadley, Steven M., Chau, Millie, Mendoza, Robinson, Tangwongchai, Tida, Koza, Casey L., Geraci, Olivia, Nunez, Lizbeth, Waters, Alexander M., Durkalski-Mauldin, Valerie, Elmunzer, B Joseph, Foster, Lydia D, Coté, Gregory A, Edmundowicz, Steven A, Singh, Vikesh K, Kwon, Richard S, Scheiman, James M, Willingham, Field F, Keilin, Steven A, Papachristou, Georgios I, Gardner, Timothy B, Smith, Zachary L, Wang, Andrew Y, Saltzman, John R, and Spitzer, Rebecca L

Published
2024
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2. Trainee Participation and Outcomes in High-risk Endoscopic Retrograde Cholangiopancreatography: A Secondary Analysis of the Stent Versus Indomethacin Trial

Author

Serrano, Jose, Coté, Gregory A., Edmundowicz, Steven A., Shah, Raj, Bang, Ji Young, Varadarajulu, Shyam, Singh, Vikesh K., Khashab, Mouen, Kwon, Richard S., Scheiman, James M., Willingham, Field F., Keilin, Steven A., Papachristou, Georgios I., Chak, Amitabh, Slivka, Adam, Mullady, Daniel, Kushnir, Vladimir, Buxbaum, James, Keswani, Rajesh, Gardner, Timothy B., Forbes, Nauzer, Rastogi, Amit, Ross, Andrew, Law, Joanna, Yachimski, Patrick, Chen, Yen-I, Barkun, Alan, Smith, Zachary L., Petersen, Bret, Wang, Andrew Y., Saltzman, John R., Spitzer, Rebecca L., Gallegos, Jazmyne, Brennan, Case, Ordiah, Collins, Spino, Cathie, Wani, Sachin, Zhang, Jingwen, Foster, Lydia D., Durkalski-Mauldin, Valerie, and Elmunzer, B. Joseph

Published
2025
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3. Early Convalescent Plasma for High-Risk Outpatients with Covid-19

Author

Korley, Frederick K, Durkalski-Mauldin, Valerie, Yeatts, Sharon D, Schulman, Kevin, Davenport, Robertson D, Dumont, Larry J, El Kassar, Nahed, Foster, Lydia D, Hah, Jennifer M, Jaiswal, Siddartha, Kaplan, Alesia, Lowell, Ezekiel, McDyer, John F, Quinn, James, Triulzi, Darrell J, Van Huysen, Carol, Stevenson, Valerie LW, Yadav, Kabir, Jones, Christopher W, Kea, Bory, Burnett, Aaron, Reynolds, Joshua C, Greineder, Colin F, Haas, Nathan L, Beiser, David G, Silbergleit, Robert, Barsan, William, and Callaway, Clifton W

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Lung, Clinical Trials and Supportive Activities, Clinical Research, Prevention, Infectious Diseases, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Good Health and Well Being, Adolescent, Adult, Aged, Aged, 80 and over, Antibodies, Neutralizing, Antibodies, Viral, COVID-19, Disease Progression, Emergency Service, Hospital, Female, Hospitalization, Humans, Immunization, Passive, Infusions, Intravenous, Male, Middle Aged, Risk Factors, SARS-CoV-2, Single-Blind Method, Treatment Failure, Young Adult, COVID-19 Serotherapy, SIREN-C3PO Investigators, Medical and Health Sciences, General & Internal Medicine, Biomedical and clinical sciences, Health sciences
Abstract

BackgroundEarly administration of convalescent plasma obtained from blood donors who have recovered from coronavirus disease 2019 (Covid-19) may prevent disease progression in acutely ill, high-risk patients with Covid-19.MethodsIn this randomized, multicenter, single-blind trial, we assigned patients who were being treated in an emergency department for Covid-19 symptoms to receive either one unit of convalescent plasma with a high titer of antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or placebo. All the patients were either 50 years of age or older or had one or more risk factors for disease progression. In addition, all the patients presented to the emergency department within 7 days after symptom onset and were in stable condition for outpatient management. The primary outcome was disease progression within 15 days after randomization, which was a composite of hospital admission for any reason, seeking emergency or urgent care, or death without hospitalization. Secondary outcomes included the worst severity of illness on an 8-category ordinal scale, hospital-free days within 30 days after randomization, and death from any cause.ResultsA total of 511 patients were enrolled in the trial (257 in the convalescent-plasma group and 254 in the placebo group). The median age of the patients was 54 years; the median symptom duration was 4 days. In the donor plasma samples, the median titer of SARS-CoV-2 neutralizing antibodies was 1:641. Disease progression occurred in 77 patients (30.0%) in the convalescent-plasma group and in 81 patients (31.9%) in the placebo group (risk difference, 1.9 percentage points; 95% credible interval, -6.0 to 9.8; posterior probability of superiority of convalescent plasma, 0.68). Five patients in the plasma group and 1 patient in the placebo group died. Outcomes regarding worst illness severity and hospital-free days were similar in the two groups.ConclusionsThe administration of Covid-19 convalescent plasma to high-risk outpatients within 1 week after the onset of symptoms of Covid-19 did not prevent disease progression. (SIREN-C3PO ClinicalTrials.gov number, NCT04355767.).

Published
2021

4. Impact of difficult biliary cannulation on post-ERCP pancreatitis: secondary analysis of the stent versus indomethacin trial dataset

Author

Han, Samuel, Zhang, Jingwen, Durkalski-Mauldin, Valerie, Foster, Lydia D., Serrano, Jose, Coté, Gregory A., Bang, Ji Young, Varadarajulu, Shyam, Singh, Vikesh K., Khashab, Mouen, Kwon, Richard S., Scheiman, James M., Willingham, Field F., Keilin, Steven A., Groce, J. Royce, Lee, Peter J., Krishna, Somashekar G., Chak, Amitabh, Slivka, Adam, Mullady, Daniel, Kushnir, Vladimir, Buxbaum, James, Keswani, Rajesh, Gardner, Timothy B., Wani, Sachin, Edmundowicz, Steven A., Shah, Raj J., Forbes, Nauzer, Rastogi, Amit, Ross, Andrew, Law, Joanna, Yachimski, Patrick, Chen, Yen-I, Barkun, Alan, Smith, Zachary L., Petersen, Bret T., Wang, Andrew Y., Saltzman, John R., Spitzer, Rebecca L., Spino, Cathie, Elmunzer, B. Joseph, and Papachristou, Georgios I.

Published
2024
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5. Deferoxamine mesylate in patients with intracerebral haemorrhage (i-DEF): a multicentre, randomised, placebo-controlled, double-blind phase 2 trial

Author

Selim, Magdy, Foster, Lydia D, Moy, Claudia S, Xi, Guohua, Hill, Michael D, Morgenstern, Lewis B, Greenberg, Steven M, James, Michael L, Singh, Vineeta, Clark, Wayne M, Norton, Casey, Palesch, Yuko Y, Yeatts, Sharon D, Investigators, i-DEF, Dolan, Monica, Yeh, Erlinda, Sheth, Kevin, Kunze, Kimberly, Muehlschlegel, Susanne, Nieto, Iryna, Claassen, Jan, Falo, Cristina, Huang, David, Beckwith, Anne, Messe, Steven, Yates, Melissa, O'Phelan, Kristine, Escobar, Andrea, Becker, Kyra, Tanzi, Patricia, Gonzales, Nicole, Tremont, Chad, Venkatasubramanian, Chitra, Thiessen, Rosita, Save, Supriya, Verrault, Steven, Collard, Karin, DeGeorgia, Michael, Cwiklinski, Valerie, Thompson, Bradford, Wasilewski, Lesley, Andrews, Charles, Burfeind, Robert, Torbey, Michel, Hamed, Mohammad, Butcher, Kenneth, Sivakumar, Leka, Varelas, Nicolaou, Mays-Wilson, Kathleen, Leira, Enrique, Olalde, Heena, Silliman, Scott, Calhoun, Rhonda, Dangayach, Neha, Renvill, Ricardo, Malhotra, Rishi, Kordesch, Kristina, Lord, Aaron, Calahan, Thomas, Geocadin, Romergryko, Parish, Michelle, Frey, James, Harrigan, Mary, Leifer, Dana, Mathias, Ryna, Schneck, Michael, Bernier, Tara, Gonzales-Arias, Sergio, Elysee, Josette, Lopez, George, Volgi, Josephine, Brown, Robert, Jasak, Sara, Phillips, Stephen, Jarrett, Judith, Gomes, Joao, McBride, Moneen, Aldrich, Francois, Aldrich, Charlene, Kornbluth, Joshua, Bettle, Michelle, Goldstein, Joshua, Tirrell, Gregory, Shaw, Qaisar, and Jonczak, Karin

Subjects
Neurosciences, Clinical Research, Clinical Trials and Supportive Activities, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Aged, Cerebral Hemorrhage, Deferoxamine, Double-Blind Method, Female, Humans, Infusions, Intravenous, Iron Chelating Agents, Male, Medical Futility, Middle Aged, Negative Results, Prospective Studies, Risk Assessment, Treatment Outcome, i-DEF Investigators, Clinical Sciences, Neurology & Neurosurgery
Abstract

BackgroundIron from haemolysed blood is implicated in secondary injury after intracerebral haemorrhage. We aimed to assess the safety of the iron chelator deferoxamine mesylate in patients with intracerebral haemorrhage and to establish whether the drug merits investigation in a phase 3 trial.MethodsWe did a multicentre, futility-design, randomised, placebo-controlled, double-blind, phase 2 trial at 40 hospitals in Canada and the USA. Adults aged 18-80 years with primary, spontaneous, supratentorial intracerebral haemorrhage were randomly assigned (1:1) to receive deferoxamine mesylate (32 mg/kg per day) or placebo (saline) infusions for 3 consecutive days within 24 h of haemorrhage onset. Randomisation was done via a web-based trial-management system centrally in real time, and treatment allocation was concealed from both participants and investigators. The primary outcome was good clinical outcome, which was defined as a modified Rankin Scale score of 0-2 at day 90. We did a futility analysis: if the 90% upper confidence bound of the absolute risk difference between the two groups in the proportion of participants with a good clinical outcome was less than 12% in favour of deferoxamine mesylate, then to move to a phase 3 efficacy trial would be futile. Primary outcome and safety data were analysed in the modified intention-to-treat population, comprising only participants in whom the study infusions were initiated. This trial is registered with ClinicalTrials.gov, number NCT02175225, and is completed.FindingsWe recruited 294 participants between Nov 23, 2014, and Nov 10, 2017. The modified intention-to-treat population consisted of 144 patients assigned to the deferoxamine mesylate group and 147 assigned to the placebo group. At day 90, among patients with available data for the primary outcome, 48 (34%) of 140 participants in the deferoxamine mesylate group, and 47 (33%) of 143 patients in the placebo group, had modified Rankin Scale scores of 0-2 (adjusted absolute risk difference 0·6% [90% upper confidence bound 6·8%]). By day 90, 70 serious adverse events were reported in 39 (27%) of 144 patients in the deferoxamine mesylate group, and 78 serious adverse events were reported in 49 (33%) of 147 patients in the placebo group. Ten (7%) participants in the deferoxamine mesylate and 11 (7%) in the placebo group died. None of the deaths were judged to be treatment related.InterpretationDeferoxamine mesylate was safe. However, the primary result showed that further study of the efficacy of deferoxamine mesylate with anticipation that the drug would significantly improve the chance of good clinical outcome (ie, mRS score of 0-2) at day 90 would be futile.FundingUS National Institutes of Health and US National Institute of Neurological Disorders and Stroke.

Published
2019

6. Digestive Manifestations in Patients Hospitalized With Coronavirus Disease 2019

Author

Elmunzer, B. Joseph, Spitzer, Rebecca L., Foster, Lydia D., Merchant, Ambreen A., Howard, Eric F., Patel, Vaishali A., West, Mary K., Qayed, Emad, Nustas, Rosemary, Zakaria, Ali, Piper, Marc S., Taylor, Jason R., Jaza, Lujain, Forbes, Nauzer, Chau, Millie, Lara, Luis F., Papachristou, Georgios I., Volk, Michael L., Hilson, Liam G., Zhou, Selena, Kushnir, Vladimir M., Lenyo, Alexandria M., McLeod, Caroline G., Amin, Sunil, Kuftinec, Gabriela N., Yadav, Dhiraj, Fox, Charlie, Kolb, Jennifer M., Pawa, Swati, Pawa, Rishi, Canakis, Andrew, Huang, Christopher, Jamil, Laith H., Aneese, Andrew M., Glamour, Benita K., Smith, Zachary L., Hanley, Katherine A., Wood, Jordan, Patel, Harsh K., Shah, Janak N., Agarunov, Emil, Sethi, Amrita, Fogel, Evan L., McNulty, Gail, Haseeb, Abdul, Trieu, Judy A., Dixon, Rebekah E., Yang, Jeong Yun, Mendelsohn, Robin B., Calo, Delia, Aroniadis, Olga C., LaComb, Joseph F., Scheiman, James M., Sauer, Bryan G., Dang, Duyen T., Piraka, Cyrus R., Shah, Eric D., Pohl, Heiko, Tierney, William M., Mitchell, Stephanie, Condon, Ashwinee, Lenhart, Adrienne, Dua, Kulwinder S., Kanagala, Vikram S., Kamal, Ayesha, Singh, Vikesh K., Pinto-Sanchez, Maria Ines, Hutchinson, Joy M., Kwon, Richard S., Korsnes, Sheryl J., Singh, Harminder, Solati, Zahra, Willingham, Field F., Yachimski, Patrick S., Conwell, Darwin L., Mosier, Evan, Azab, Mohamed, Patel, Anish, Buxbaum, James, Wani, Sachin, Chak, Amitabh, Hosmer, Amy E., Keswani, Rajesh N., DiMaio, Christopher J., Bronze, Michael S., Muthusamy, Raman, Canto, Marcia I., Gjeorgjievski, V. Mihajlo, Imam, Zaid, Odish, Fadi, Edhi, Ahmed I., Orosey, Molly, Tiwari, Abhinav, Patwardhan, Soumil, Brown, Nicholas G., Patel, Anish A., Ordiah, Collins O., Sloan, Ian P., Cruz, Lilian, Koza, Casey L., Okafor, Uchechi, Hollander, Thomas, Furey, Nancy, Reykhart, Olga, Zbib, Natalia H., Damianos, John A., Esteban, James, Hajidiacos, Nick, Saul, Melissa, Mays, Melanie, Anderson, Gulsum, Wood, Kelley, Mathews, Laura, Diakova, Galina, Caisse, Molly, Wakefield, Lauren, Nitchie, Haley, Waljee, Akbar K., Tang, Weijing, Zhang, Yueyang, Zhu, Ji, Deshpande, Amar R., Rockey, Don C., Alford, Teldon B., and Durkalski, Valerie

Published
2021
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7. An Unsuccessful Randomized Trial of Percutaneous vs Endoscopic Drainage of Suspected Malignant Hilar Obstruction

Author

Elmunzer, B. Joseph, Smith, Zachary L., Tarnasky, Paul, Wang, Andrew Y., Yachimski, Patrick, Banovac, Filip, Buscaglia, Jonathan M., Buxbaum, James, Chak, Amitabh, Chong, Bradford, Coté, Gregory A., Draganov, Peter V., Dua, Kulwinder, Durkalski, Valerie, Geller, Brian S., Jamil, Laith H., Keswani, Rajesh N., Khashab, Mouen A., Law, Ryan, Lo, Simon K., McCarthy, Sean, Selby, J. Bayne, Singh, Vikesh K., Taylor, Jason R., Willingham, Field F., Spitzer, Rebecca L., and Foster, Lydia D.

Published
2021
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9. Association Between CT Angiogram Collaterals and CT Perfusion in the Interventional Management of Stroke III Trial

Author

Vagal, Achala, Menon, Bijoy K, Foster, Lydia D, Livorine, Anthony, Yeatts, Sharon D, Qazi, Emmad, d'Esterre, Chris, Shi, Junzi, Demchuk, Andrew M, Hill, Michael D, Liebeskind, David S, Tomsick, Thomas, and Goyal, Mayank

Subjects
Epidemiology, Biomedical and Clinical Sciences, Health Sciences, Clinical Research, Stroke, Cardiovascular, Brain Disorders, Biomedical Imaging, Neurosciences, Adult, Aged, Aged, 80 and over, Arterial Occlusive Diseases, Carotid Artery Diseases, Carotid Artery, Internal, Cerebral Angiography, Cerebrovascular Circulation, Cohort Studies, Collateral Circulation, Female, Humans, Infarction, Middle Cerebral Artery, Male, Middle Aged, Perfusion Imaging, Prospective Studies, Tomography, X-Ray Computed, carotid artery, internal, collateral circulation, perfusion imaging, stroke, tomography, x-ray computed, Cardiorespiratory Medicine and Haematology, Clinical Sciences, Neurology & Neurosurgery, Clinical sciences, Allied health and rehabilitation science
Abstract

Background and purposeCollateral flow can determine ischemic core and tissue at risk. Using the Interventional Management of Stroke (IMS) III trial data, we explored the relationship between computed tomography angiogram (CTA) collateral status and CT perfusion (CTP) parameters.MethodsBaseline CTA collaterals were trichotomized as good, intermediate, and poor, and CTP studies were analyzed to quantify ischemic core, tissue at risk, and mismatch ratios. Kruskal-Wallis and Spearman tests were used to measure the strength of association and correlation between CTA collaterals and CTP parameters.ResultsA total of 95 patients had diagnostic CTP studies in the IMS III trial. Of these, 53 patients had M1/M2 middle cerebral artery±intracranial internal carotid artery occlusion, where baseline CTA collateral grading was performed. CTA collaterals were associated with smaller CTP measured ischemic core volume (P=0.0078) and higher mismatch (P=0.0004). There was moderate negative correlation between collaterals and core (rs=-0.45; 95% confidence interval, -0.64 to -0.20) and moderate positive correlation between collaterals and mismatch (rs=0.53; 95% confidence interval, 0.29-0.71).ConclusionBetter collaterals were associated with smaller ischemic core and higher mismatch in the IMS III trial. Collateral assessment and perfusion imaging identify the same biological construct about ischemic tissue sustenance.

Published
2016

10. Sphincterotomy for biliary sphincter of Oddi disorder and idiopathic acute recurrent pancreatitis: the RESPOnD longitudinal cohort

Author

Coté, Gregory A, Elmunzer, Badih Joseph, Nitchie, Haley, Kwon, Richard S, Willingham, Field, Wani, Sachin, Kushnir, Vladimir, Chak, Amitabh, Singh, Vikesh, Papachristou, Georgios I, Slivka, Adam, Freeman, Martin, Gaddam, Srinivas, Jamidar, Priya, Tarnasky, Paul, Varadarajulu, Shyam, Foster, Lydia D, and Cotton, Peter

Abstract

ObjectiveSphincter of Oddi disorders (SOD) are contentious conditions in patients whose abdominal pain, idiopathic acute pancreatitis (iAP) might arise from pressurisation at the sphincter of Oddi. The present study aimed to measure the benefit of sphincterotomy for suspected SOD.DesignProspective cohort conducted at 14 US centres with 12 months follow-up. Patients undergoing first-time endoscopic retrograde cholangiopancreatography (ERCP) with sphincterotomy for suspected SOD were eligible: pancreatobiliary-type pain with or without iAP. The primary outcome was defined as the composite of improvement by Patient Global Impression of Change (PGIC), no new or increased opioids and no repeat intervention. Missing data were addressed by hierarchal, multiple imputation scheme.ResultsOf 316 screened, 213 were enrolled with 190 (89.2%) of these having a dilated bile duct, abnormal labs, iAP or some combination. By imputation, an average of 122/213 (57.4% (95% CI 50.4% to 64.4%)) improved; response rate was similar for those with complete follow-up (99/161, 61.5% (54.0% to 69.0%)); of these, 118 (73.3%) improved by PGIC alone. Duct size, elevated labs and patient characteristics were not associated with response. AP occurred in 37/213 (17.4%) at a median of 6 months post ERCP and was more likely in those with a history of AP (30.9% vs 2.9%, p<0.0001).ConclusionNearly 60% of patients undergoing ERCP for suspected SOD improve, although the contribution of a placebo response is unknown. Contrary to prevailing belief, duct size and labs are poor response predictors. AP recurrence was common and like observations from prior non-intervention cohorts, suggesting no benefit of sphincterotomy in mitigating future AP episodes.

Published
2025
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11. Deferoxamine mesylate in patients with intracerebral haemorrhage (i-DEF): a multicentre, randomised, placebo-controlled, double-blind phase 2 trial

Author

Dolan, Monica, Yeh, Erlinda, Sheth, Kevin, Kunze, Kimberly, Muehlschlegel, Susanne, Nieto, Iryna, Claassen, Jan, Falo, Cristina, Huang, David, Beckwith, Anne, Messe, Steven, Yates, Melissa, O'Phelan, Kristine, Escobar, Andrea, Becker, Kyra, Tanzi, Patricia, Gonzales, Nicole, Tremont, Chad, Venkatasubramanian, Chitra, Thiessen, Rosita, Save, Supriya, Verrault, Steven, Collard, Karin, DeGeorgia, Michael, Cwiklinski, Valerie, Thompson, Bradford, Wasilewski, Lesley, Andrews, Charles, Burfeind, Robert, Torbey, Michel, Hamed, Mohammad, Butcher, Kenneth, Sivakumar, Leka, Varelas, Nicolaou, Mays-Wilson, Kathleen, Leira, Enrique, Olalde, Heena, Silliman, Scott, Calhoun, Rhonda, Dangayach, Neha, Renvill, Ricardo, Malhotra, Rishi, Kordesch, Kristina, Lord, Aaron, Calahan, Thomas, Geocadin, Romergryko, Parish, Michelle, Frey, James, Harrigan, Mary, Leifer, Dana, Mathias, Ryna, Schneck, Michael, Bernier, Tara, Gonzales-Arias, Sergio, Elysee, Josette, Lopez, George, Volgi, Josephine, Brown, Robert, Jasak, Sara, Phillips, Stephen, Jarrett, Judith, Gomes, Joao, McBride, Moneen, Aldrich, Francois, Aldrich, Charlene, Kornbluth, Joshua, Bettle, Michelle, Goldstein, Joshua, Tirrell, Gregory, Shaw, Qaisar, Jonczak, Karin, Selim, Magdy, Foster, Lydia D, Moy, Claudia S, Xi, Guohua, Hill, Michael D, Morgenstern, Lewis B, Greenberg, Steven M, James, Michael L, Singh, Vineeta, Clark, Wayne M, Norton, Casey, Palesch, Yuko Y, and Yeatts, Sharon D

Published
2019
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12. Recanalization and Clinical Outcome of Occlusion Sites at Baseline CT Angiography in the Interventional Management of Stroke III Trial

Author

Demchuk, Andrew M, Goyal, Mayank, Yeatts, Sharon D, Carrozzella, Janice, Foster, Lydia D, Qazi, Emmad, Hill, Michael D, Jovin, Tudor G, Ribo, Marc, Yan, Bernard, Zaidat, Osama O, Frei, Donald, von Kummer, Rüdiger, Cockroft, Kevin M, Khatri, Pooja, Liebeskind, David S, Tomsick, Thomas A, Palesch, Yuko Y, Broderick, Joseph P, and Investigators, For the I III

Subjects
Brain Disorders, Stroke, Clinical Research, Biomedical Imaging, Neurosciences, Adult, Aged, Aged, 80 and over, Cerebral Angiography, Endovascular Procedures, Female, Fibrinolytic Agents, Humans, Magnetic Resonance Angiography, Male, Middle Aged, Tissue Plasminogen Activator, Tomography, X-Ray Computed, Treatment Outcome, IMS III Investigators, Medical and Health Sciences, Nuclear Medicine & Medical Imaging
Abstract

PurposeTo use baseline computed tomographic (CT) angiography to analyze imaging and clinical end points in an Interventional Management of Stroke III cohort to identify patients who would benefit from endovascular stroke therapy.Materials and methodsThe primary clinical end point was 90-day dichotomized modified Rankin Scale (mRS) score. Secondary end points were 90-day mRS score distribution and 24-hour recanalization. Prespecified subgroup was baseline proximal occlusions (internal carotid, M1, or basilar arteries). Exploratory analyses were subsets with any occlusion and specific sites of occlusion (two-sided α = .01).ResultsOf 656 subjects, 306 (47%) underwent baseline CT angiography or magnetic resonance angiography. Of 306, 282 (92%) had arterial occlusions. At baseline CT angiography, proximal occlusions (n = 220) demonstrated no difference in primary outcome (41.3% [62 of 150] endovascular vs 38% [27 of 70] intravenous [IV] tissue-plasminogen activator [tPA]; relative risk, 1.07 [99% confidence interval: 0.67, 1.70]; P = .70); however, 24-hour recanalization rate was higher for endovascular treatment (n = 167; 84.3% [97 of 115] endovascular vs 56% [29 of 52] IV tPA; P < .001). Exploratory subgroup analysis for any occlusion at baseline CT angiography did not demonstrate significant differences between endovascular and IV tPA arms for primary outcome (44.7% [85 of 190] vs 38% [35 of 92], P = .29), although ordinal shift analysis of full mRS distribution demonstrated a trend toward more favorable outcome (P = .011). Carotid T- or L-type occlusion (terminal internal carotid artery [ICA] with M1 middle cerebral artery and/or A1 anterior cerebral artery involvement) or tandem (extracranial or intracranial) ICA and M1 occlusion subgroup also showed a trend favoring endovascular treatment over IV tPA alone for primary outcome (26% [12 of 46] vs 4% [one of 23], P = .047).ConclusionSignificant differences were identified between treatment arms for 24-hour recanalization in proximal occlusions; carotid T- or L-type and tandem ICA and M1 occlusions showed greater recanalization and a trend toward better outcome with endovascular treatment. Vascular imaging should be mandated in future endovascular trials to identify such occlusions. Online supplemental material is available for this article.

Published
2014

13. Time to angiographic reperfusion and clinical outcome after acute ischaemic stroke: an analysis of data from the Interventional Management of Stroke (IMS III) phase 3 trial

Author

Khatri, Pooja, Yeatts, Sharon D, Mazighi, Mikael, Broderick, Joseph P, Liebeskind, David S, Demchuk, Andrew M, Amarenco, Pierre, Carrozzella, Janice, Spilker, Judith, Foster, Lydia D, Goyal, Mayank, Hill, Michael D, Palesch, Yuko Y, Jauch, Edward C, Haley, E Clarke, Vagal, Achala, Tomsick, Thomas A, and Trialists, for the IMS III

Subjects
Brain Disorders, Clinical Research, Neurosciences, Stroke, Cardiovascular, Adolescent, Adult, Aged, Brain Ischemia, Carotid Artery Diseases, Cerebral Angiography, Endovascular Procedures, Female, Fibrinolytic Agents, Humans, Infarction, Middle Cerebral Artery, Male, Middle Aged, Reperfusion, Time Factors, Tissue Plasminogen Activator, Tomography Scanners, X-Ray Computed, Treatment Outcome, Young Adult, IMS III Trialists, Clinical Sciences, Neurology & Neurosurgery
Abstract

BackgroundThe IMS III trial did not show a clinical benefit of endovascular treatment compared with intravenous alteplase (recombinant tissue plasminogen activator) alone for moderate or severe ischaemic strokes. Late reperfusion of tissue that was no longer salvageable could be one explanation, as suggested by previous exploratory studies that showed an association between time to reperfusion and good clinical outcome. We sought to validate this association in a preplanned analysis of data from the IMS III trial.MethodsWe used data for patients with complete proximal arterial occlusions in the anterior circulation who received endovascular treatment and achieved angiographic reperfusion (score on Thrombolysis in Cerebral Infarction scale of grade 2-3) during the endovascular procedure (within 7 h of symptom onset). We used logistic regression to model good clinical outcome (defined as a modified Rankin Scale score of 0-2 at 3 months) as a function of the time to reperfusion. We prespecified variables to be considered for adjustment, including age, baseline National Institutes of Health Stroke Scale score, sex, and baseline blood glucose concentration.FindingsOf 240 patients who were otherwise eligible for inclusion in our analysis, 182 (76%) achieved angiographic reperfusion. Mean time from symptom onset to reperfusion (ie, procedure end) was 325 min (SD 52). Increased time to reperfusion was associated with a decreased likelihood of good clinical outcome (unadjusted relative risk for every 30-min delay 0·85 [95% CI 0·77-0·94]; adjusted relative risk 0·88 [0·80-0·98]).InterpretationDelays in time to angiographic reperfusion lead to a decreased likelihood of good clinical outcome in patients after moderate to severe stroke. Rapid reperfusion could be crucial for the success of future acute endovascular trials.FundingUS National Institutes of Health and National Institute of Neurological Disorders and Stroke.

Published
2014

14. Collaterals at Angiography and Outcomes in the Interventional Management of Stroke (IMS) III Trial

Author

Liebeskind, David S, Tomsick, Thomas A, Foster, Lydia D, Yeatts, Sharon D, Carrozzella, Janice, Demchuk, Andrew M, Jovin, Tudor G, Khatri, Pooja, von Kummer, Ruediger, Sugg, Rebecca M, Zaidat, Osama O, Hussain, Syed I, Goyal, Mayank, Menon, Bijoy K, Al Ali, Firas, Yan, Bernard, Palesch, Yuko Y, and Broderick, Joseph P

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Neurosciences, Cerebrovascular, Clinical Research, Brain Disorders, Stroke, Biomedical Imaging, Clinical Trials and Supportive Activities, Adult, Aged, Aged, 80 and over, Blood Pressure, Cerebral Angiography, Collateral Circulation, Comorbidity, Diabetes Complications, Endovascular Procedures, Female, Fibrinolytic Agents, Humans, Male, Middle Aged, Multivariate Analysis, Reperfusion Injury, Thrombolytic Therapy, Tissue Plasminogen Activator, Treatment Outcome, Young Adult, angiography, collateral circulation, reperfusion, stroke, IMS III Investigators, Cardiorespiratory Medicine and Haematology, Neurology & Neurosurgery, Clinical sciences, Allied health and rehabilitation science
Abstract

Background and purposeEndovascular strategies provide unique opportunity to correlate angiographic measures of collateral circulation at the time of endovascular therapy. We conducted systematic analyses of collaterals at conventional angiography on recanalization, reperfusion, and clinical outcomes in the endovascular treatment arm of the Interventional Management of Stroke (IMS) III trial.MethodsProspective evaluation of angiographic collaterals was conducted via central review of subjects treated with endovascular therapy in IMS III (n=331). Collateral grade before endovascular therapy was assessed with the American Society of Interventional and Therapeutic Neuroradiology/Society of Interventional Radiology scale, blinded to all other data. Statistical analyses investigated the association between collaterals with baseline clinical variables, angiographic measures of recanalization, reperfusion and clinical outcomes.ResultsAdequate views of collateral circulation to the ischemic territory were available in 276 of 331 (83%) subjects. Collateral grade was strongly related to both recanalization of the occluded arterial segment (P=0.0016) and downstream reperfusion (P

Published
2014

16. Cigarette Smoking as a Risk Factor for Hematoma Expansion in Primary Intracerebral Hemorrhage: Analysis From a Randomized Clinical Trial

Author

Schupper, Alexander J., primary, Khorasanizadeh, Mirhojjat, additional, Rossitto, Christina P., additional, Foster, Lydia D., additional, Kellner, Christopher P., additional, Suarez, Jose I., additional, Qureshi, Adnan I., additional, Majidi, Shahram, additional, Palesch, Yuko Y., additional, Martin, Renee L., additional, Barsan, William G., additional, Silbergleit, Robert, additional, Hanley, Daniel F., additional, Moy, Claudia S., additional, Hsu, Chung Y., additional, Steiner, Thorsten, additional, Toyoda, Kazunori, additional, Wang, Yongjun, additional, Yamamoto, Haruko, additional, and Yoon, Byung‐Woo, additional

Published
2023
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17. Blood Pressure-Attained Analysis of ATACH 2 Trial

Author

Qureshi, Adnan I., Palesch, Yuko Y., Foster, Lydia D., Barsan, William G., Goldstein, Joshua N., Hanley, Daniel F., Hsu, Chung Y., Moy, Claudia S., Qureshi, Mushtaq H., Silbergleit, Robert, Suarez, Jose I., Toyoda, Kazunori, and Yamamoto, Haruko

Published
2018
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18. Percutaneous transhepatic vs. endoscopic retrograde biliary drainage for suspected malignant hilar obstruction: study protocol for a randomized controlled trial

Author

Al-Kawas, Firas, Aslanian, Harry, Baillie, John, Banovac, Filip, Buscaglia, Jonathan M., Buxbaum, James, Chak, Amitabh, Chong, Bradford, Coté, Gregory A., Draganov, Peter V., Dua, Kulwinder, Durkalski, Valerie, Elmunzer, B. Joseph, Foster, Lydia D., Gardner, Timothy B., Geller, Brian S., Jamidar, Priya, Jamil, Laith H., Keswani, Rajesh N., Khashab, Mouen A., Lang, Gabriel D., Law, Ryan, Lichtenstein, David, Lo, Simon K., McCarthy, Sean, Melo, Silvio, Mullady, Daniel, Nieto, Jose, Bayne Selby, J., Singh, Vikesh K., Spitzer, Rebecca L., Strife, Brian, Tarnaksy, Paul, Taylor, Jason R., Tokar, Jeffrey, Wang, Andrew Y., Williams, April, Willingham, Field, Yachimski, Patrick, and In alphabetical order for the INTERCPT Study Group and the United States Cooperative for Outcomes Research in Endoscopy (USCORE)

Published
2018
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20. Effect of Deferoxamine on Outcome According to Baseline Hematoma Volume: A Post Hoc Analysis of the i-DEF Trial

Author

Wei, Chenchen, primary, Wang, Jeffrey, additional, Foster, Lydia D., additional, Yeatts, Sharon D., additional, Moy, Claudia, additional, Mocco, J, additional, Selim, Magdy, additional, Palesch, Yuko, additional, Griffin, Jessica, additional, Perlmutter, Aaron, additional, Norton, Casey, additional, Dillon, Catherine, additional, Thornhill, Andre, additional, Greenberg, Steven, additional, Morgenstern, Lewis, additional, Hanley, Daniel, additional, Xi, Guohua, additional, Bleck, Thomas P, additional, Balk, Robert, additional, Zhao, Wenle, additional, Kim, Jaemyung, additional, Kumar, Sandeep, additional, Farinella, Megan, additional, Siwila-Sackman, Erica, additional, Feigert, Caroline, additional, Schlaug, Gottfried, additional, Wang, Jasmine, additional, Wright, Clinton, additional, Janis, Scott, additional, Gilbert, Peter, additional, Kase, Carlos S, additional, Carson, Shannon, additional, Flaherty, Matthew, additional, Kessler, Craig M, additional, McClure, Leslie A, additional, Bannon, Donna, additional, Broderick, Joseph, additional, and Dill, Amy, additional

Published
2022
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21. sj-docx-2-ctj-10.1177_17407745221105897 – Supplemental material for An adaptive clinical trial design to identify the target dose of tenecteplase for treatment of acute pulmonary embolism

Author

Yeatts, Sharon D, Foster, Lydia D, Barsan, William G, Berry, Nicholas S, Callaway, Clifton W, Lewis, Roger J, Saville, Benjamin R, Silbergleit, Robert, and Kline, Jeffrey A

Subjects
FOS: Clinical medicine, 160807 Sociological Methodology and Research Methods, humanities, 111599 Pharmacology and Pharmaceutical Sciences not elsewhere classified, FOS: Sociology
Abstract

Supplemental material, sj-docx-2-ctj-10.1177_17407745221105897 for An adaptive clinical trial design to identify the target dose of tenecteplase for treatment of acute pulmonary embolism by Sharon D Yeatts, Lydia D Foster, William G Barsan, Nicholas S Berry, Clifton W Callaway, Roger J Lewis, Benjamin R Saville, Robert Silbergleit and Jeffrey A Kline in Clinical Trials

Published
2022
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22. 559 PATIENT CHARACTERISTICS ARE ASSOCIATED WITH RESPONSE TO ERCP FOR SPHINCTER OF ODDI DISORDERS, BUT PHYSICIAN-DEFINED SOD SUBTYPES ARE NOT: THE RESPOND LONGITUDINAL COHORT STUDY

Author

Cote, Gregory A., Nitchie, Haley, Elmunzer, Badih J., Kwon, Richard, Willingham, Field F., Wani, Sachin B., Kushnir, Vladimir, Chak, Amitabh, Singh, Vikesh, Papachristou, Georgios, Slivka, Adam, Freeman, Martin L., Gaddam, Srinivas, Jamidar, Priya A., Tarnasky, Paul R., Varadarajulu, Shyam, Foster, Lydia D., and Cotton, Peter B.

Published
2024
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23. Endovascular Therapy Is Effective and Safe for Patients With Severe Ischemic Stroke: Pooled Analysis of Interventional Management of Stroke III and Multicenter Randomized Clinical Trial of Endovascular Therapy for Acute Ischemic Stroke in the Netherlands Data

Author

Broderick, Joseph P., Berkhemer, Olvert A., Palesch, Yuko Y., Dippel, Diederik W.J., Foster, Lydia D., Roos, Yvo B.W.E.M., van der Lugt, Aad, Tomsick, Thomas A., Majoie, Charles B.L.M., van Zwam, Wim H., Demchuk, Andrew M., van Oostenbrugge, Robert J., Khatri, Pooja, Lingsma, Hester F., Hill, Michael D., Roozenbeek, Bob, Jauch, Edward C., Jovin, Tudor G., Yan, Bernard, von Kummer, Rüdiger, Molina, Carlos A., Goyal, Mayank, Schonewille, Wouter J., Mazighi, Mikael, Engelter, Stefan T., Anderson, Craig S., Spilker, Judith, Carrozzella, Janice, Ryckborst, Karla J., Janis, L. Scott, and Simpson, Kit N.

Published
2015
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24. Twelve-Month Clinical and Quality-of-Life Outcomes in the Interventional Management of Stroke III Trial

Author

Palesch, Yuko Y., Yeatts, Sharon D., Tomsick, Thomas A., Foster, Lydia D., Demchuk, Andrew M., Khatri, Pooja, Hill, Michael D., Jauch, Edward C., Jovin, Tudor G., Yan, Bernard, von Kummer, Rüdiger, Molina, Carlos A., Goyal, Mayank, Schonewille, Wouter J., Mazighi, Mikael, Engelter, Stefan T., Anderson, Craig, Spilker, Judith, Carrozzella, Janice, Ryckborst, Karla J., Janis, L. Scott, Simpson, Annie, Simpson, Kit N., and Broderick, Joseph P.

Published
2015
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26. Evolution of Practice During the Interventional Management of Stroke III Trial and Implications for Ongoing Trials

Author

Broderick, Joseph P., Palesch, Yuko Y., Demchuk, Andrew M., Yeatts, Sharon D., Khatri, Pooja, Hill, Michael D., Jauch, Edward C., Jovin, Tudor G., Yan, Bernard, von Kummer, Rüdiger, Molina, Carlos A., Goyal, Mayank, Mazighi, Mikael, Schonewille, Wouter J., Engelter, Stefan T., Anderson, Craig, Spilker, Judith, Carrozzella, Janice, Janis, L. Scott, Foster, Lydia D., and Tomsick, Thomas A.

Published
2014
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31. Endovascular Therapy after Intravenous t-PA versus t-PA Alone for Stroke

Author

Broderick, Joseph P., Palesch, Yuko Y., Demchuk, Andrew M., Yeatts, Sharon D., Khatri, Pooja, Hill, Michael D., Jauch, Edward C., Jovin, Tudor G., Yan, Bernard, Silver, Frank L., von Kummer, Rüdiger, Molina, Carlos A., Demaerschalk, Bart M., Budzik, Ronald, Clark, Wayne M., Zaidat, Osama O., Malisch, Tim W., Goyal, Mayank, Schonewille, Wouter J., Mazighi, Mikael, Engelter, Stefan T., Anderson, Craig, Spilker, Judith, Carrozzella, Janice, Ryckborst, Karla J., Janis, Scott L., Martin, Renée H., Foster, Lydia D., and Tomsick, Thomas A.

Published
2013
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35. The role of endoscopy and findings in COVID-19 patients, an early North American Cohort.

Author

Kuftinec, Gabriela, Elmunzer, B. Joseph, Amin, Sunil, North American Alliance for the Study of Digestive Manifestations of Covid-19, Elmunzer, Joseph, Spitzer, Rebecca L., Foster, Lydia D., Merchant, Ambreen A., Howard, Eric F., Patel, Vaishali A., West, Mary K., Qayad, Emad, Nustas, Rosemary, Zakaria, Ali, Piper, Marc S., Taylor, Jason R., Jaza, Lujain, Forbes, Nauzer, Chau, Millie, and Lara, Luis F.

Subjects
COVID-19, GASTROINTESTINAL hemorrhage, ENDOSCOPY, ENTEROSCOPY, CRITICALLY ill, RESOURCE allocation
Abstract

Background and Aims: Gastrointestinal manifestations in patients with COVID-19 are common but the role of endoscopy in this patient population remains unclear. We investigated the need for endoscopic procedures, their findings, and impact on patient care in a systematic and geographically diverse sample of patients hospitalized with COVID-19.Methods: As part of the North American Alliance for the Study of Digestive Manifestations of COVID-19, we identified consecutive patients hospitalized with COVID-19 at 36 medical centers in the USA and Canada. We performed a secondary analysis of patients who underwent endoscopy, collecting information on endoscopic indications, findings, interventions, staffing, procedure location, anesthesia utilization, and adverse events.Results: Data were collected on 1992 patients; 24 (1.2%) underwent 27 endoscopic procedures (18 upper endoscopies, 7 colonoscopies, 2 endoscopic retrograde cholangiopancreatographies). The most common indications were: gastrointestinal bleeding (13) and enteral access (6). The most common findings were erosive or inflammatory changes. Ten patients underwent an endoscopic intervention for hemostatic therapy (2), enteral access (6), or biliary obstruction (2). Half of cases employed anesthesiology support; no sedation-related adverse events were reported. One-third of cases were performed in the intensive care setting and one quarter in the endoscopy unit.Conclusions: In this large, systematic, geographically diverse cohort of patients hospitalized with COVID-19 in North America, very few patients underwent endoscopy despite a high prevalence of gastrointestinal manifestations. Almost all endoscopic findings and interventions were thought related to critical illness rather than direct viral injury. This systematic assessment of endoscopic necessity and outcomes may help guide resource allocation in the event of ongoing and future surges. [ABSTRACT FROM AUTHOR]

Published
2021
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37. Erratum : Endovascular therapy is effective and safe for patients with severe ischemic stroke: Pooled analysis of Interventional Management of Stroke III and Multicenter Randomized Clinical Trial of Endovascular Therapy for Acute Ischemic Stroke in the Netherlands Data (Stroke (2015) 46 (3416-3422) DOI: 10.1161/STROKEAHA.115.011397)

Author

Broderick, Joseph P., Berkhemer, Olvert A., Palesch, Yuko Y., Dippel, Diederik W J, Foster, Lydia D., Roos, Y.B.W.E.M., van der Lugt, A., Tomsick, Thomas A., Majoie, Charles B L M, van Zwam, Wim H, Demchuk, Andrew M., van Oostenbrugge, R. J., Khatri, Pooja, Lingsma, Hester F., Hill, Michael D., Roozenbeek, Bob, Jauch, Edward C., Jovin, Tudor G., Yan, Bernard, von Kummer, R., Molina, Carlos A., Goyal, Mayank, Schonewille, Wouter J., Mazighi, M., Engelter, Stefan T., Anderson, Craig S., Spilker, Judith, Carrozzella, Janice, Ryckborst, Karla J., Janis, L. Scott, and Simpson, Kit N.

Subjects
Published Erratum, Clinical Neurology, Advanced and Specialised Nursing, Cardiology and Cardiovascular Medicine
Published
2016

38. Differential effect of baseline CTA Collaterals on Clinical Outcome in patients enrolled in the IMS-III trial

Author

Menon, Bijoy K., Qazi, Emmad, Nambiar, Vivek, Foster, Lydia D., Yeatts, Sharon D., Liebeskind, David, Jovin, Tudor G., Goyal, Mayank, Hill, Michael D., Tomsick, Thomas A., Broderick, Joseph P., and Demchuk, Andrew M.

Subjects
Adult, Aged, 80 and over, Male, Endovascular Procedures, Collateral Circulation, Middle Aged, Article, Brain Ischemia, Cerebral Angiography, Stroke, Treatment Outcome, Fibrinolytic Agents, Tissue Plasminogen Activator, Image Processing, Computer-Assisted, Humans, Female, Thrombolytic Therapy, Tomography, X-Ray Computed, Aged
Abstract

In the Interventional Management of Stroke (IMS) III trial, we sought to demonstrate evidence of a differential treatment effect of endovascular treatment of acute ischemic stroke compared with intravenous tissue-type plasminogen activator, according to baseline collateral status measured using computed tomographic angiography.Of 656 patients enrolled in Interventional Management of Stroke III trial, 306 had baseline computed tomographic angiography. Of these, 185 patients had M1 middle cerebral artery ± intracranial internal carotid artery occlusion, where baseline collateral status could be measured. Collateral status was assessed by consensus using 3 different ordinal scales and categorized as good, intermediate, and poor. Multivariable modeling was used to assess the effect of collateral status and treatment type on clinical outcome by modified Rankin Scale (mRS 0-2, mRS 0-1, and the ordinal mRS).Of 185 patients, 126 randomized to endovascular therapy (87.6% recanalized, 41.3% 90-day mRS 0-2) and 59 to intravenous tissue-type plasminogen activator only (60.5% recanalized, 30.5% 90-day mRS 0-2). In multivariable modeling, collateral status was a significant predictor of all clinical outcomes (P0.05). Maximal benefit with endovascular treatment across all clinical outcomes was seen in patients with intermediate collaterals, some benefit in patients with good collaterals, and none in patients with poor collaterals, although small sample size limited the power of the analysis to show a statistically significant interaction between collateral status and treatment type (P0.05).Using data from a large randomized controlled trial (IMS III), we show that baseline computed tomographic angiography collaterals are a robust determinant of final clinical outcome and could be used to select patients for endovascular therapy.URL: http://www.clinicaltrials.gov/ct2/show/. Unique identifier: 0020NCT00359424.

Published
2015

39. Erratum: Endovascular therapy is effective and safe for patients with severe ischemic stroke: Pooled analysis of Interventional Management of Stroke III and Multicenter Randomized Clinical Trial of Endovascular Therapy for Acute Ischemic Stroke in the Netherlands Data (Stroke (2015) 46 (3416-3422) DOI: 10.1161/STROKEAHA.115.011397)

Author

ZL Algemene Neurologie Medisch, Broderick, Joseph P., Berkhemer, Olvert A., Palesch, Yuko Y., Dippel, Diederik W J, Foster, Lydia D., Roos, Y.B.W.E.M., van der Lugt, A., Tomsick, Thomas A., Majoie, Charles B L M, van Zwam, Wim H, Demchuk, Andrew M., van Oostenbrugge, R. J., Khatri, Pooja, Lingsma, Hester F., Hill, Michael D., Roozenbeek, Bob, Jauch, Edward C., Jovin, Tudor G., Yan, Bernard, von Kummer, R., Molina, Carlos A., Goyal, Mayank, Schonewille, Wouter J., Mazighi, M., Engelter, Stefan T., Anderson, Craig S., Spilker, Judith, Carrozzella, Janice, Ryckborst, Karla J., Janis, L. Scott, Simpson, Kit N., ZL Algemene Neurologie Medisch, Broderick, Joseph P., Berkhemer, Olvert A., Palesch, Yuko Y., Dippel, Diederik W J, Foster, Lydia D., Roos, Y.B.W.E.M., van der Lugt, A., Tomsick, Thomas A., Majoie, Charles B L M, van Zwam, Wim H, Demchuk, Andrew M., van Oostenbrugge, R. J., Khatri, Pooja, Lingsma, Hester F., Hill, Michael D., Roozenbeek, Bob, Jauch, Edward C., Jovin, Tudor G., Yan, Bernard, von Kummer, R., Molina, Carlos A., Goyal, Mayank, Schonewille, Wouter J., Mazighi, M., Engelter, Stefan T., Anderson, Craig S., Spilker, Judith, Carrozzella, Janice, Ryckborst, Karla J., Janis, L. Scott, and Simpson, Kit N.

Published
2016

40. The Challenges of Decision-making Regarding Futility in a Randomized Trial: the IMS III Experience

Author

Yeatts, Sharon D, Martin, Renee’ H, Coffey, Christopher S, Lyden, Patrick D, Foster, Lydia D, Woolson, Robert F, Broderick, Joseph P, Di Tullio, Marco R., Jungreis, Charles A, and Palesch, Yuko Y

Subjects
Decision Making, Disease Management, Combined Modality Therapy, Severity of Illness Index, Article, Brain Ischemia, Stroke, Treatment Outcome, Fibrinolytic Agents, Research Design, Data Interpretation, Statistical, Tissue Plasminogen Activator, Humans, Thrombolytic Therapy, Medical Futility, Randomized Controlled Trials as Topic
Abstract

Interventional Management of Stroke (IMS) III is a randomized, parallel arm trial comparing the approach of intravenous tissue-type plasminogen activator followed by endovascular treatment with intravenous tissue-type plasminogen activator alone in patients with acute ischemic stroke presenting3 hours of symptom onset. The trial intended to enroll 900 subjects to ensure adequate statistical power to detect an absolute 10% difference in the percentage of subjects with good outcome, defined as modified Rankin Scale score of 0 to 2 at 3 months. In April 2012, after 656 subjects were randomized, further enrollment was terminated by the National Institute of Neurological Disorders and Stroke based on the prespecified criterion for futility using conditional power20%.Conditional power was defined as the likelihood of finding statistical significance at the end of the study, given the accumulated data to date and with the assumption that a minimum hypothesized difference of 10% truly exists between the 2 groups. The evolution of study data leading to futility determination is described, including the interaction between the unblinded study statisticians and the Data and Safety Monitoring Board in the complex deliberation of analysis results.The futility boundary was crossed at the trial's fourth interim analysis. At this point, based on the conditional power criteria, the Data and Safety Monitoring Board recommended termination of the trial.Even in spite of prespecified interim analysis boundaries, interim looks at data pose challenges in interpretation and decision making, underscoring the importance of objective stopping criteria.http://www.clinicaltrials.gov. Unique identifier: NCT00359424.

Published
2014

43. Endovascular therapy is effective and safe for patients with severe ischemic stroke: Pooled analysis of interventional management of Stroke III and multicenter randomized clinical trial of endovascular therapy for acute ischemic stroke in the Netherlands data

Author

ZL Algemene Neurologie Medisch, Broderick, Joseph P., Berkhemer, Olvert A., Palesch, Yuko Y., Dippel, Diederik W J, Foster, Lydia D., Roos, Yvo B. W. E. M., van der Lugt, Aad, Tomsick, Thomas A., Majoie, Charles B L M, van Zwam, Wim H, Demchuk, Andrew M., Oostenbrugge, Robert J., Khatri, Pooja, Lingsma, Hester F., Hill, Michael D., Roozenbeek, Bob, Jauch, Edward C., Jovin, Tudor G., Yan, Bernard, Von Kummer, Rüdiger, Molina, Carlos A., Goyal, Mayank, Schonewille, Wouter J., Mazighi, Mikael, Engelter, Stefan T., Anderson, Craig S., Spilker, Judith, Carrozzella, Janice, Ryckborst, Karla J., Janis, L. Scott, Simpson, Kit N., ZL Algemene Neurologie Medisch, Broderick, Joseph P., Berkhemer, Olvert A., Palesch, Yuko Y., Dippel, Diederik W J, Foster, Lydia D., Roos, Yvo B. W. E. M., van der Lugt, Aad, Tomsick, Thomas A., Majoie, Charles B L M, van Zwam, Wim H, Demchuk, Andrew M., Oostenbrugge, Robert J., Khatri, Pooja, Lingsma, Hester F., Hill, Michael D., Roozenbeek, Bob, Jauch, Edward C., Jovin, Tudor G., Yan, Bernard, Von Kummer, Rüdiger, Molina, Carlos A., Goyal, Mayank, Schonewille, Wouter J., Mazighi, Mikael, Engelter, Stefan T., Anderson, Craig S., Spilker, Judith, Carrozzella, Janice, Ryckborst, Karla J., Janis, L. Scott, and Simpson, Kit N.

Published
2015

44. Abstract T P12: Intraarterial (IA) Iodinated Radiographic Contrast Media (IRCM) Effect in the Interventional Management of Stroke (IMS) III Trial

Author

Tomsick, Thomas, primary, Foster, Lydia D, additional, Yeatts, Sharon D, additional, Hill, Michael D, additional, Carrozzella, Janice, additional, Liebeskind, David S, additional, Khatri, Pooja, additional, Goyal, Mayank, additional, Puetz, Volker, additional, Dzialowski, Imanuel, additional, Morales, Humberto, additional, Demchuk, Andrew M, additional, Palesch, Yuko Y, additional, and Broderick, Joseph P, additional

Published
2015
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46. Rationale and Design of the Statin Use in Intracerebral Hemorrhage Patients (SATURN) Trial.

Author

Marchina, Sarah, Yeatts, Sharon D., Foster, Lydia D., Janis, Scott, Shoamanesh, Ashkan, Khatri, Pooja, Bernstein, Kimberlee, Perlmutter, Aaron, Stever, Catherine, Heistand, Elizabeth C., Broderick, Joseph P., Greenberg, Steven M., Leira, Enrique C., Rosand, Jonathan, Lioutas, Vasileios-Arsenios, Salman, Rustam Al Shahi, Tirschwell, David, Marti-Fabregas, Joan, and Selim, Magdy

Abstract

Introduction: The benefits and risks of HMG-CoA reductase inhibitor (statin) drugs in survivors of intracerebral hemorrhage (ICH) are unclear. Observational studies suggest an association between statin use and increased risk of lobar ICH, particularly in patients with apolipoprotein-E (APOE) ε2 and ε4 genotypes. There are no randomized controlled trials addressing the effects of statins after ICH leading to uncertainty as to whether statins should be used in patients with lobar ICH who are at high risk for ICH recurrence. The SATURN trial aims to evaluate the effects of continuation versus discontinuation of statin on the risk of ICH recurrence and ischemic major adverse cerebro-cardio-vascular events (MACCEs) in patients with lobar ICH. Secondary aims include the assessment of whether the APOE genotype modifies the effects of statins on ICH recurrence, functional and cognitive outcomes, and quality of life. Methods: The SATURN trial is a multi-center, pragmatic, prospective, randomized, open-label, phase III clinical trial with blinded end-point assessment. A planned total of 1,456 patients with lobar ICH will be recruited from 140 sites in the USA, Canada, and Spain. Patients presenting within 7 days of a spontaneous lobar ICH that occurred while taking a statin will be randomized (1:1) to continuation (control) versus discontinuation (intervention) of the same statin drug and dose that they were using at ICH onset. The primary outcome is the time to recurrent symptomatic ICH within a 2-year follow-up period. The primary safety outcome is the occurrence of ischemic MACCE. Conclusion: The results will help to determine the best strategy for statin use in survivors of lobar ICH and may help to identify if there is a subset of patients who would benefit from or be harmed by statins. [ABSTRACT FROM AUTHOR]

Published
2024
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47. Observed Cost and Variations in Short Term Cost-Effectiveness of Therapy for Ischemic Stroke in Interventional Management of Stroke (IMS) III.

Author

Simpson, Kit N., Simpson, Annie N., Mauldin, Patrick D., Palesch, Yuko Y., Yeatts, Sharon D., Kleindorfer, Dawn, Tomsick, Thomas A., Foster, Lydia D., Demchuk, Andrew M., Khatri, Pooja, Hill, Michael D., Jauch, Edward C., Jovin, Tudor G., Yan, Bernard, Kummer, Rüdiger von, Molina, Carlos A., Goyal, Mayank, Schonewille, Wouter J., Mazighi, Mikael, and Engelter, Stefan T.

Published
2017
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50. Abstract 7: Differential Effect of Baseline Cta Collateral Status on Clinical Outcomes in Patients Enrolled in the Ims-3 Trial

Author

Menon, Bijoy K, primary, Qazi, Emmad, additional, Nambiar, Vivek, additional, Foster, Lydia D, additional, Yeatts, Sharon, additional, Liebeskind, David, additional, Jovin, Tudor, additional, Hill, Michael D, additional, Goyal, Mayank, additional, Tomsick, Tom, additional, Broderick, Joseph, additional, and Demchuk, Andrew M, additional

Published
2014
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