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Statistically and clinically significant cognitive declines are observed in a small subset of individuals with Parkinson's Disease (PD) following treatment with Deep Brain Stimulation (DBS).We examine the association between multi-domain cognitive decline (MCD) and demographic and baseline clinical variables and the incidence of serious adverse events (SAE) arising within a six-month interval following DBS for PD.Study participants with PD who displayed MCD at 6-month follow-up evaluation after DBS (n = 18) were contrasted with individuals with PD from the same study who did not show cognitive decline after DBS (n = 146). Logistic regression analyses were employed to assess relationship between predictors, including age (70 years old), pre-DBS cognitive screening test performance, SAE, and MCD. MCD+ and MCD-groups were also compared on other baseline clinical and demographic variables.MCD showed modest association with older age and lower baseline neurocognitive screening performance, whereas the groups did not differ on most other baseline clinical and demographic variables. SAEs during the study interval were the most robust predictor of MCD in the DBS group. A variety of SAEs were documented in study participants experiencing MCD after DBS surgery, including, but not limited to, infections and small intracranial hemorrhages.Older age and lower baseline cognition measured prior to treatment are associated with MCD measured at six-months after DBS. SAE occurring following DBS surgery are also predictive of MCD. These predictors may reflect aspects of "frailty" in advanced PD. Risk factors for SAE warrant careful consideration in clinical trials.

Background and Purpose: Fewer women than men tend to be enrolled in clinical trials of intracerebral hemorrhage. It is unclear whether this reflects lower prevalence of intracerebral hemorrhage in women, selection bias, or poor recruitment efforts. We undertook this study to examine differences between men and women in the reasons for exclusion from the iDEF trial (Intracerebral Hemorrhage Deferoxamine). Methods: The screen failure log included 29 different reasons for exclusion. Chi-square statistics were used to evaluate the differences in reasons for exclusion between men and women. Results: A total of 38.2% of participants in iDEF were women. Three thousand nine hundred eighty-two women (45.7%) and 4736 men (54.3%) were screen failures ( P P =0.1). Patients or families declined participation in 1.26% of women versus 1.31% of men ( P =0.9). More women than men failed screening because of age>80 (22.40% versus 12.61%; adjusted P =0.0007) and preexisting do-not-resuscitate/do-not-intubate (3.69% versus 2.83%; adjusted P =0.067). Conclusions: Lower rates of women enrollment in the iDEF trial may be attributed to older age. Inability to obtain consent or declining participation was similar between women and men, arguing against selection bias. Our findings should be confirmed in other intracerebral hemorrhage trials to determine best strategies to improve women’s representation in future trials.

RATIONALE AND OBJECTIVE: The safety of intensive blood pressure (BP) targets is controversial for persons with chronic kidney disease (CKD). We studied the effects of hypertension treatment on cerebral perfusion and structure in those with and without CKD. STUDY DESIGN: Neuroimaging substudy of a randomized trial. SETTING & PARTICIPANTS: A subset of participants in the Systolic Blood Pressure Intervention Trial who underwent brain MRI studies. Presence of baseline CKD was assessed by estimated glomerular filtration rate (eGFR) and urine albumin to creatinine ratio (UACR). INTERVENTION: Participants were randomly assigned to intensive (systolic BP 30 mg/g (N=151), the effects of intensive versus standard BP treatment on change in global cerebral blood flow, WMLs and total brain volume were 1.91 ml/100g/min (95% CI −3.01, 6.82), 0.003 cm(3) (asinh transformed, 95% CI −0.13, 0.13), and −7.0 cm(3) (95% CI −13.3, −0.3), respectively. The overall treatment effects on cerebral blood flow and total brain volume were not modified by baseline eGFR or UACR; however the effect on WMLs was attenuated in participants with albuminuria (interaction p-value 0.04). LIMITATIONS: Measurement variability due to multi-site design. CONCLUSIONS: Among hypertensive adults with primarily early kidney disease, intensive versus standard blood pressure treatment did not appear to have a detrimental effect on brain perfusion or structure. The findings support the safety of intensive blood pressure treatment targets on brain health in persons with early kidney disease. FUNDING: The Systolic Blood Pressure Intervention Trial was funded by the National Institutes of Health (including the National Heart, Lung, and Blood Institute, the National Institute of Diabetes and Digestive and Kidney Diseases, the National Institute on Aging, and the National Institute of Neurological Disorders and Stroke), and this substudy was funded by the National Institutes of Diabetes and Digestive and Kidney Diseases. TRIAL REGISTRATION: SPRINT was registered at ClinicalTrials.gov with the study number NCT01206062.

Introduction: Small vessel disease is associated with decreased cognitive function, possibly differential by race. Age-related central arterial stiffening increases pulsatility resulting in hypoperfusion, microvascular damage and remodeling in the brain, potentially impairing cognition. We examined if arterial stiffness and pressure amplification are associated with lacunar infarcts and greater volumes of white matter hyperintensities (WMH) in a sample of Caucasian and African American (AA) older adults. Methods: We analyzed a cross-sectional sample of ARIC participants aged 67-90 years (n=1486) from visit 5 (2011-2013), with brain magnetic resonance imaging (MRI). The Omron VP-1000 Plus was used to measure aortic stiffness (carotid-femoral pulse wave velocity [cfPWV]) and pressure amplification measures (pulse pressure amplification [PPA], central pulse pressure [cPP], and estimated central systolic blood pressure [cSBP]). Aortic stiffness and pressure amplification were dichotomized at race-specific 25th percentile cut points. Brain MRI using 3D-1.5T equipment quantified the presence of lacunar infarcts and volumes of WMH following a standardized protocol. Logistic regression, adjusted for age, sex, education, ApoE4, heart rate, smoking and body mass index, was used to quantify the odds of lacunar infarcts in participants with high vs. low cfPWV, cPP, cSBP, and low vs. high PPA. Linear regression models, additionally adjusted for intracranial volume, estimated the difference in log-transformed volumes of WMH among participants with high vs. low cfPWV, cPP, cSBP, and low vs. high PPA. Probability sampling weights for an MRI were included to allow for generalizability to the full visit 5 cohort. Results: Among the 1486 participants with a brain MRI (mean age: 76, 41% male, 26% AA), measures of aortic stiffness and pressure amplification were associated with lacunar infarcts in Caucasians, but not in AAs. Caucasian participants with a high cfPWV had greater odds of lacunar infarcts (Odds Ratio [OR] =2.02, 95% confidence interval [CI]: 1.23, 2.20). Caucasians with high cSBP had higher odds of lacunar infarcts (OR=1.72, 95% CI: 1.10, 2.69). In Caucasians, high cfPWV was associated with a 21% (95% CI: 6, 38) greater volume of WMH as compared to a low cfPWV; high cSBP was associated with a 28% (95% CI: 14, 45) greater volume of WMH compared to a low cSBP. In AAs, high cfPWV was associated with a 32% (95% CI: 7, 62) greater volume of WMH as compared to low cfPWV. Cerebral microvascular imaging markers did not differ quantitatively with measures of PPA and cPP. Conclusions: Central arterial stiffening and pressure amplification are plausible microvascular contributors to cognitive aging, providing new information on modifiable pathways for previously observed associations between cardiovascular disease risk factors and the rates of cognitive decline and dementia among older adults.

Neuro-QoL is a multidimensional patient-reported outcome measurement system assessing aspects of physical, mental, and social health identified by neurology patients and caregivers as important. One of the first neurology-specific patient-reported outcome measure systems created using modern test development methods, Neuro-Qol enables brief, yet precise, assessment and the ability to conduct both PD-specific and cross-disease comparisons. We present results of Neuro-QoL clinical validation using a sample of PD patients.A total of 120 PD patients recruited from academic medical centers were assessed at baseline, 1 week, and 6 months. Assessments included Neuro-QoL and general and PD-specific validity measures.Participants were 62% male and 95% white (average age = 66); HY stages were 1 (16%), 2 (61%), 3 (18%), and 4 (5%). Internal consistency and test-retest reliability of Neuro-QoL ranged from Cronbach's alphas = 0.81 to 0.94 with intraclass correlation coefficients = 0.66 to 0.80. Pearson's correlations between Neuro-QoL and legacy measures were generally moderate and in expected directions. UPDRS Part 2 was moderately correlated with Neuro-QoL Upper Extremity and Mobility, respectively (r's = -0.44; -0.59). Parkinson's Disease Questionnaire-39 and Neuro-QoL measures of similar constructs showed strong-to-moderate correlations (r's = 0.70-0.44). Neuro-QoL measures of fatigue, mobility, positive emotion, and emotional/behavioral control showed responsiveness to self-reported change.Neuro-QoL is valid for use in PD clinical research. Reliability for all but two measures is sufficient for group comparisons, with some evidence supporting responsiveness to change. Neuro-QoL possesses characteristics, such as brevity, flexibility in administration, and suitability, for cross-disease comparisons that may be advantageous to users in a variety of settings. © 2016 Movement Disorder Society.

Background&Purpose: There are limited diet regarding the potential association of adherence to Mediterranean Diet (MeD) with incident stroke. We sought to determine longitudinally the relationship between higher adherence to Mediterranean diet and lower likelihood of incident stroke before and after controlling for factors that are independently related to cerebrovascular disease burden by capitalizing on the large, geographically dispersed, race- and gender-balanced sample of REGARDS subjects. Subjects&Methods: A prospective, population-based, cohort of individuals enrolled in REGARDS Study was evaluated after excluding participants with history of stroke and missing data with respect to demographic, cognitive or food intake variables. Adherence to a MeD was computed from Food Frequency Questionnaires (FFQ) and was categorized as high, moderate and low using MeD-score tertiles (MeD-score: 6-9, 4-5 & 0-3 respectively). The main outcome of the present analyses was incident stroke that had been diagnosed by a committee of trained clinicians during a mean follow-up period of 5 years. The association of adherence to MeD with incident stroke (ischemic and hemorrhagic) was evaluated using a set of incremental logistic regression models. Results: Incident stroke was identified in 565 (1.9%; 497 cases of ischemic and 68 cases of hemorrhagic stroke) out of 30,239 individuals fulfilling the inclusion criteria. After adjusting for age, race, region, gender, income, education, total energy, smoking status, sedentary behavior, body mass index, waist circumference and vascular risk factors, low adherence to MeD was associated with a higher likelihood of incident ischemic stroke (OR versus high adherence: 1.29; 95%CI:0.99-1.67; p=0.057). A similar relationship was documented for moderate adherence to MeD (OR versus high adherence: 1.25; 95%CI:0.98-1.58; p=0.079). We documented no association of adherence to MeD with incident hemorrhagic stroke (p=0.38). There was no interaction of race (p=0.38) on the association of adherence to MeD with incident ischemic stroke. Conclusions: Low adherence to MeD was associated with a higher likelihood of incident ischemic stroke independent of numerous potential confounders.

The Collaborative Ocular Melanoma Study (COMS) is a set of randomized clinical trials sponsored by the National Eye Institute of the National Institutes of Health. The COMS is being conducted to evaluate the role of radiotherapy in the treatment of patients with choroidal melanoma. Primary choroidal melanoma can enlarge or metastasize and eventually cause death in a significant percentage of cases. The primary COMS trial is designed to determine whether enucleation (removal of the eye) or radiotherapy without removal of the eye provides the patient with the longest remaining lifespan. More than 40 clinical centers in the United States and Canada are participating in the COMS. The objective of the COMS is to assess the effect of treatment upon 5-year and 10-year survival and the reduction or elimination of the disease process in patients randomly assigned to receive either radiation or enucleation. An ancillary component of the COMS, referred to as the COMS-QOLS, was designed to measure the impact of disea...

Excess urinary albumin excretion is more common in black than white individuals and is more strongly associated with incident stroke risk in black vs white individuals. Whether similar associations extend to coronary heart disease (CHD) is unclear.To determine whether the association of urinary albumin excretion with CHD events differs by race.Prospective cohort study of black and white US adults aged 45 years and older who were enrolled within the Reasons for Geographic and Racial Differences in Stroke (REGARDS) study between 2003 and 2007 with follow-up through December 31, 2009. We examined race-stratified associations of urinary albumin-to-creatinine ratio (ACR) in 2 groups: (1) incident CHD among 23,273 participants free of CHD at baseline; and (2) first recurrent CHD event among 4934 participants with CHD at baseline.Expert-adjudicated incident and recurrent myocardial infarction and acute CHD death.A total of 616 incident CHD events (421 nonfatal MIs and 195 CHD deaths) and 468 recurrent CHD events (279 nonfatal MIs and 189 CHD deaths) were observed over a mean time of 4.4 years of follow-up. Among those free of CHD at baseline, age- and sex-adjusted incidence rates of CHD per 1000 person-years of follow-up increased with increasing categories of ACR in black and white participants, with rates being nearly 1.5-fold greater in the highest category of ACR (300 mg/g) in black participants (20.59; 95% CI, 14.36-29.51) vs white participants (13.60; 95% CI, 7.60-24.25). In proportional hazards models adjusted for traditional cardiovascular risk factors and medications, higher baseline urinary ACR was associated with greater risk of incident CHD among black participants (hazard ratio [HR] comparing ACR300 vs10 mg/g, 3.21 [95% CI, 2.02-5.09]) but not white participants (HR comparing ACR300 vs10 mg/g, 1.49 [95% CI, 0.80-2.76]) (P value for interaction = .03). Among those with CHD at baseline, fully adjusted associations of baseline urinary ACR with first recurrent CHD event were similar between black participants (HR comparing ACR300 vs10 mg/g, 2.21 [95% CI, 1.22-4.00]) vs white participants (HR comparing ACR300 vs10 mg/g, 2.48 [95% CI, 1.61-3.78]) (P value for interaction = .53).Higher urinary ACR was associated with greater risk of incident but not recurrent CHD in black individuals when compared with white individuals. These data confirm that black individuals appear more susceptible to vascular injury.

Background and Purpose— In a previous study, 0.3 and 0.45 mg/kg of intravenous recombinant tissue plasminogen activator (rt-PA) were safe when combined with eptifibatide 75 mcg/kg bolus and a 2-hour infusion (0.75 mcg/kg per minute). The Combined Approach to Lysis Utilizing Eptifibatide and rt-PA in Acute Ischemic Stroke–Enhanced Regimen (CLEAR-ER) trial sought to determine the safety of a higher-dose regimen and to establish evidence for a phase III trial. Methods— CLEAR-ER was a multicenter, double-blind, randomized safety study. Ischemic stroke patients were randomized to 0.6 mg/kg rt-PA plus eptifibatide (135 mcg/kg bolus and a 2-hour infusion at 0.75 mcg/kg per minute) versus standard rt-PA (0.9 mg/kg). The primary safety end point was the incidence of symptomatic intracranial hemorrhage within 36 hours. The primary efficacy outcome measure was the modified Rankin Scale (mRS) score ≤1 or return to baseline mRS at 90 days. Analysis of the safety and efficacy outcomes was done with multiple logistic regression. Results— Of 126 subjects, 101 received combination therapy, and 25 received standard rt-PA. Two (2%) patients in the combination group and 3 (12%) in the standard group had symptomatic intracranial hemorrhage (odds ratio, 0.15; 95% confidence interval, 0.01–1.40; P =0.053). At 90 days, 49.5% of the combination group had mRS ≤1 or return to baseline mRS versus 36.0% in the standard group (odds ratio, 1.74; 95% confidence interval, 0.70–4.31; P =0.23). After adjusting for age, baseline National Institutes of Health Stroke Scale, time to intravenous rt-PA, and baseline mRS, the odds ratio was 1.38 (95% confidence interval, 0.51–3.76; P =0.52). Conclusions— The combined regimen of intravenous rt-PA and eptifibatide studied in this trial was safe and provides evidence that a phase III trial is warranted to determine efficacy of the regimen. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00894803.

Background and Purpose— Black/white disparities in stroke incidence are well documented, but few studies have assessed the contributions to the disparity. Here we assess the contribution of “traditional” risk factors. Methods— A total of 25 714 black and white men and women, aged ≥45 years and stroke-free at baseline, were followed for an average of 4.4 years to detect stroke. Mediation analysis using proportional hazards analysis assessed the contribution of traditional risk factors to racial disparities. Results— At age 45 years, incident stroke risk was 2.90 (95% CI: 1.72–4.89) times more likely in blacks than in whites and 1.66 (95% CI: 1.34–2.07) times at age 65 years. Adjustment for risk factors attenuated these excesses by 40% and 45%, respectively, resulting in relative risks of 2.14 (95% CI: 1.25–3.67) and 1.35 (95% CI: 1.08–1.71). Approximately one half of this mediation is attributable to systolic blood pressure. Further adjustment for socioeconomic factors resulted in total mediation of 47% and 53% to relative risks of 2.01 (95% CI: 1.16–3.47) and 1.30 (1.03–1.65), respectively. Conclusions— Between ages 45 to 65 years, approximately half of the racial disparity in stroke risk is attributable to traditional risk factors (primarily systolic blood pressure) and socioeconomic factors, suggesting a critical need to understand the disparity in the development of these traditional risk factors. Because half of the excess stroke risk in blacks is not attributable to traditional risk factors and socioeconomic factors, differential impact of risk factors, residual confounding, or nontraditional risk factors may also play a role.

Background and purpose Periodontal disease results in tooth loss, may contribute to systemic inflammation, and is associated with stroke. We examined cross-sectional associations between tooth loss, inflammation markers, stroke, race, and geographic region among participants in the reasons for geographic and racial differences in stroke (REGARDS) study of whites and blacks ≥45 years. Methods We studied 24,393 participants. Associations of tooth loss and inflammation markers (C-reactive protein (CRP), white blood cell count (WBC) and albumin) were examined by linear regression, and associations of tooth loss with geographic region, race, and prevalent stroke by logistic regression. Results Compared to whites, blacks had an odds ratio of 1.48 (95% confidence interval 1.37–1.60) of having more teeth lost. There were no geographic differences in tooth loss. Compared to no tooth loss, those with 17–32 teeth lost had 1.17mg/L higher CRP ( p × 10 9 /L higher WBC ( p =0.008), did not differ in albumin, and had an odds ratio of prevalent stroke of 1.28 (1.09–1.49). Those with 1–16 teeth lost did not differ in CRP and WBC, had 0.03g/dL higher albumin ( p =0.004), and had no increased stroke prevalence. CRP or WBC did not attenuate associations between tooth loss and stroke. Conclusions Tooth loss, which varied with race, but not region of residence, was associated with inflammation markers and stroke. The latter association was not confounded by inflammation markers.

We thank Drs Robert Adams, Gary Friday, Philip Gorelick, and Sylvia Wasserthiel-Smoller, members of Stroke Statistics Subcommittee; Drs Joe Broderick, Brian Eigel, Kimberlee Gauveau, Jane Khoury, Jerry Potts, Jane Newburger, and Kathryn Taubert; and Sean Coady and Michael Wolz for their valuable comments and contributions. We acknowledge Tim Anderson and Tom Schneider for their editorial contributions and Karen Modesitt for her administrative assistance. View this table: Writing Group Disclosures # Summary {#article-title-2} Each year the American Heart Association, in conjunction with the Centers for Disease Control and Prevention, the National Institutes of Health, and other government agencies, brings together the most up-to-date statistics on heart disease, stroke, and their risk factors and presents them in its Heart Disease and Stroke Statistical Update. The Statistical Update is a valuable resource for researchers, clinicians, healthcare policy makers, media, the lay public, and many others who seek the …

The Pittsburgh project evaluating the epidemiology and etiology of insulin-dependent diabetes mellitus (IDDM) is currently one of the large ongoing studies of childhood diabetes. This paper traces the evolution of the project, from the initial basic epidemiologic approach in the early 1980s, to the current thrust where complex molecular genetic approaches are being incorporated into population-based research. The epidemiology models employed in the Pittsburgh project are similar to those that could be used in many areas of chronic disease research. The integration of immunogenetics into epidemiology produces a powerful approach for understanding the complex interaction of host susceptibility and environmental agents that contribute to the development of IDDM.

1. About These Statistics…e70 2. Cardiovascular Diseases…e72 3. Coronary Heart Disease, Acute Coronary Syndrome, and Angina Pectoris…e89 4. Stroke…e99 5. High Blood Pressure…e111 6. Congenital Cardiovascular Defects…e116 7. Heart Failure…e119 8. Other Cardiovascular Diseases…e122 9. Risk Factor: Smoking/Tobacco Use…e128 10. Risk Factor: High Blood Cholesterol and Other Lipids…e132 11. Risk Factor: Physical Inactivity…e136 12. Risk Factor: Overweight and Obesity…e139 13. Risk Factor: Diabetes Mellitus…e143 14. End-Stage Renal Disease and Chronic Kidney Disease…e149 15. Metabolic Syndrome…e151 16. Nutrition…e153 17. Quality of Care…e155 18. Medical Procedures…e159 19. Economic Cost of Cardiovascular Diseases…e162 20. At-a-Glance Summary Tables…e164 21. Glossary and Abbreviation Guide…e168 Writing Group Disclosures…e171 Appendix I: List of Statistical Fact Sheets: http://www.americanheart.org/presenter.jhtml?identifier=2007 We thank Drs Robert Adams, Philip Gorelick, Matt Wilson, and Philip Wolf (members of the Statistics Committee or Stroke Statistics Subcommittee); Brian Eigel; Gregg Fonarow; Kathy Jenkins; Gail Pearson; and Michael Wolz for their valuable comments and contributions. We would like to acknowledge Tim Anderson and Tom Schneider for their editorial contributions and Karen Modesitt for her administrative assistance. # 1. About These Statistics {#article-title-2} The American Heart Association (AHA) works with the Centers for Disease Control and Prevention’s National Center for Health Statistics (CDC/NCHS); the National Heart, Lung, and Blood Institute (NHLBI); the National Institute of Neurological Disorders and Stroke (NINDS); and other government agencies to derive the annual statistics in this Update. This chapter describes the most important sources and the types of data we use from them. For more details and an alphabetical list of abbreviations, see Chapter 21 of this document, the Glossary and Abbreviation Guide. The surveys used are

To assess the internal consistency of a short, widely-used health-related quality of life instrument in patients with choroidal melanoma, its appropriateness for use in a large clinical trial in patients with that disease, and the feasibility of various methods of instrument administration.The SF-36 was administered to 31 choroidal melanoma patients identified from two ocular oncology practices. Fifteen patients were interviewed by telephone, 4 were interviewed in person at the clinic, and 12 patients completed the instrument themselves while at the clinic.Twenty-three patients had already been treated for choroidal melanoma; 20 patients were treated with some form of radiation. The remaining 8 patients had not yet been treated. Metastasis had not been diagnosed in any of the patients. Patient age ranged from 37 to 85 years with a median of 59 years; 55% of the patients were female. The in-person and telephone interviews performed better than self-administered interviews in terms of missing items due to non-response (0% vs. 3.2%). The overall SF-36 health profile for the choroidal melanoma patients was similar in shape to that expected for a general U.S. population sample with the same age and gender distribution, although the choroidal melanoma patients averaged 4 to 11 points higher, indicating better health-related quality of life, for all scales except the role functioning-emotional scale.The results supported the internal consistency of the SF-36 in this population. Interviewer administration of the SF-36 either in-person or by telephone was acceptable to the patients and provided more complete data.