1. Design and Rationale of the National Tunisian Registry of Percutaneous Coronary Intervention: Protocol for a Prospective Multicenter Observational Study
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Hanene Charfeddine, Khaled Ben Jemaa, Fares Azaiez, Achraf Gargouri, Selma Charfeddine, Sabeur Mnif, Tawfik Kateb, Karim Bejjar, Leila Bezdah, Mohsen Ben Jemaa, Sana Fennira, Chiheb Hamza, Abdelkader Maalej, Moufid Hadrich, Bassem Rekik, Sami Marouene, Amin Bahloul, Souad Mallek, Yassine Ellouz, Rania Hammami, Walid Jomaa, Mohamed Aymen Ben Abdessalem, Bassem Jerbi, Nizar Saadaoui, Faycal Elleuch, Slim Boudiche, Jamel Langar, Leila Abid, Zahreddine Smiri, Samir Kammoun, Amine Amara, Faouzi Maatoug, Sami Ouannes, Habib Ben Ahmed, Wafa Fehri Siala, Tarek Ellouz, Maher Sahnoun, Faouzi Drissi, Abdeljelil Farhati, Sondes Kraiem, Chedly Abbassi, Ahmed Siala, Nejeh Ben Hlima, Sami Fourati, Zied Ibn Bel Hadj, Amir Zouari, Mohamed Akrem Drissa, Tarek Ben Chedli, Amin Hadiji, Mariem Dghim, Elyes Kharrat, Rami Tlili, Majed Hassine, Nidhal Bouchahda, Kais Battikh, Elyes Nafati, Mokdad Ayari, Morched Hadrich, Rym Gribaa, Nebil Hamrouni, Yamen Maazoun, Hichem Denguir Denguir, Nabil Marsit, Salem Kachboura, Hassen Hadj Amor, Salem Abdesselem, Hatem Bouraoui, Sofiene Zayed, Hedi Ben Slima, Mohamed Hmem, Kamel Kamoun, Gouider Jeridi, Zeineb Grati, Khaldoun Ben Hamda, Helmi Ben Salem, Wacef Ayadi, Mostari Gharbi, Fatma Boujelben Masmoudi, Slim Chtourou, Youssef Ben Ameur, Mohamed Sahnoun, Habib Gamra, Imtinen Ben Mrad, Ahmed Jamel, Imen Gtif, Helmi Kamoun, Mohamed Sami Mourali, S. Milouchi, Abdallah Mahdhaoui, L. Zakhama, Lobna Laroussi, Sabri Maaoui, Morched Marouene, F. Addad, and Aymen Noamen
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Protocol (science) ,medicine.medical_specialty ,business.industry ,medicine.medical_treatment ,Emergency medicine ,Medicine ,Percutaneous coronary intervention ,Observational study ,General Medicine ,business - Abstract
Background Coronary artery diseases remain the leading cause of death in the world. The management of this condition has improved remarkably in the recent years owing to the development of new technical tools and multicentric registries. Objective The aim of this study is to investigate the in-hospital and 1-year clinical outcomes of patients treated with percutaneous coronary intervention (PCI) in Tunisia. Methods We will conduct a prospective multicentric observational study with patients older than 18 years who underwent PCI between January 31, 2020 and June 30, 2020. The primary end point is the occurrence of a major adverse cardiovascular event, defined as cardiovascular death, myocardial infarction, cerebrovascular accident, or target vessel revascularization with either repeat PCI or coronary artery bypass grafting (CABG). The secondary end points are procedural success rate, stent thrombosis, and the rate of redo PCI/CABG for in-stent restenosis. Results In this study, the demographic profile and the general risk profile of Tunisian patients who underwent PCI and their end points will be analyzed. The complexity level of the procedures and the left main occlusion, bifurcation occlusion, and chronic total occlusion PCI will be analyzed, and immediate as well as long-term results will be determined. The National Tunisian Registry of PCI (NATURE-PCI) will be the first national multicentric registry of angioplasty in Africa. For this study, the institutional ethical committee approval was obtained (0223/2020). This trial consists of 97 cardiologists and 2498 patients who have undergone PCI with a 1-year follow-up period. Twenty-eight catheterization laboratories from both public (15 laboratories) and private (13 laboratories) sectors will enroll patients after receiving informed consent. Of the 2498 patients, 1897 (75.9%) are managed in the public sector and 601 (24.1%) are managed in the private sector. The COVID-19 pandemic started in Tunisia in March 2020; 719 patients (31.9%) were included before the COVID-19 pandemic and 1779 (60.1%) during the pandemic. The inclusion of patients has been finished, and we expect to publish the results by the end of 2022. Conclusions This study would add data and provide a valuable opportunity for real-world clinical epidemiology and practice in the field of interventional cardiology in Tunisia with insights into the uptake of PCI in this limited-income region. Trial Registration Clinicaltrials.gov NCT04219761; https://clinicaltrials.gov/ct2/show/NCT04219761 International Registered Report Identifier (IRRID) RR1-10.2196/24595
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- 2022