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