TY - JOUR AU - Hammami, Rania AU - Boudiche, Selim AU - Rami, Tlili AU - Ben Halima, Nejeh AU - Jamel, Ahmed AU - Rekik, Bassem AU - Gribaa, Rym AU - Imtinene, Ben Mrad AU - Charfeddine, Salma AU - Ellouze, Tarek AU - Bahloul, Amine AU - Hédi, Ben Slima AU - Langar, Jamel AU - Ben Ahmed, Habib AU - Ibn Elhadj, Zied AU - Hmam, Mohamed AU - Ben Abdessalem, Mohamed Aymen AU - Maaoui, Sabri AU - Fennira, Sana AU - Lobna, Laroussi AU - Hassine, Majed AU - Ouanes, Sami AU - Mohamed Faouzi, Drissi AU - Mallek, Souad AU - Mahdhaoui, Abdallah AU - Meriem, Dghim AU - Jomaa, Walid AU - Zayed, Sofien AU - Kateb, Tawfik AU - Bouchahda, Nidhal AU - Azaiez, Fares AU - Ben Salem, Helmi AU - Marouen, Morched AU - Noamen, Aymen AU - Abdesselem, Salem AU - Hichem, Denguir AU - Ibn Hadj Amor, Hassen AU - Abdeljelil, Farhati AU - Amara, Amine AU - Bejar, Karim AU - Khaldoun, Ben Hamda AU - Hamza, Chiheb AU - Ben Jamaa, Mohsen AU - Fourati, Sami AU - Elleuch, Faycal AU - Grati, Zeineb AU - Chtourou, Slim AU - Marouene, Sami AU - Sahnoun, Mohamed AU - Hadrich, Morched AU - Mohamed Abdelkader, Maalej AU - Bouraoui, Hatem AU - Kamoun, Kamel AU - Hadrich, Moufid AU - Ben Chedli, Tarek AU - Drissa, Mohamed Akrem AU - Charfeddine, Hanene AU - Saadaoui, Nizar AU - Achraf, Gargouri AU - Ahmed, Siala AU - Ayari, Mokdad AU - Nabil, Marsit AU - Mnif, Sabeur AU - Sahnoun, Maher AU - Kammoun, Helmi AU - Ben Jemaa, Khaled AU - Mostari, Gharbi AU - Hamrouni, Nebil AU - Yamen, Maazoun AU - Ellouz, Yassine AU - Smiri, Zahreddine AU - Hdiji, Amine AU - Bassem, Jerbi AU - Ayadi, Wacef AU - Zouari, Amir AU - Abbassi, Chedly AU - Fatma, Boujelben Masmoudi AU - Battikh, Kais AU - Kharrat, Elyes AU - Gtif, Imen AU - Sami, Milouchi AU - Bezdah, Leila AU - Kachboura, Salem AU - Maatouk, Mohamed Faouzi AU - Kraiem, Sondes AU - Jeridi, Gouider AU - Neffati, Elyes AU - Kammoun, Samir AU - Ben Ameur, Youssef AU - Fehri, Wafa AU - Gamra, Habib AU - Zakhama, Lilia AU - Addad, Faouzi AU - Mohamed Sami, Mourali AU - Abid, Leila PY - 2022 DA - 2022/8/5 TI - Design and Rationale of the National Tunisian Registry of Percutaneous Coronary Intervention: Protocol for a Prospective Multicenter Observational Study JO - JMIR Res Protoc SP - e24595 VL - 11 IS - 8 KW - percutaneous coronary intervention KW - 1-year outcome KW - Tunisia KW - national KW - multicentric KW - registry KW - percutaneous KW - coronary KW - artery disease AB - 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 SN - 1929-0748 UR - https://www.researchprotocols.org/2022/8/e24595 UR - https://doi.org/10.2196/24595 UR - http://www.ncbi.nlm.nih.gov/pubmed/35930353 DO - 10.2196/24595 ID - info:doi/10.2196/24595 ER -