Dataset Information

Design and Rationale of the National Tunisian Registry of Percutaneous Coronary Intervention: Protocol for a Prospective Multicenter Observational Study.

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.

SUBMITTER: Hammami R

PROVIDER: S-EPMC9391981 | biostudies-literature | 2022 Aug

REPOSITORIES: biostudies-literature

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Publications

Design and Rationale of the National Tunisian Registry of Percutaneous Coronary Intervention: Protocol for a Prospective Multicenter Observational Study.

Hammami Rania R Boudiche Selim S Rami Tlili T Ben Halima Nejeh N Jamel Ahmed A Rekik Bassem B Gribaa Rym R Imtinene Ben Mrad BM Charfeddine Salma S Ellouze Tarek T Bahloul Amine A Hédi Ben Slima BS Langar Jamel J Ben Ahmed Habib H Ibn Elhadj Zied Z Hmam Mohamed M Ben Abdessalem Mohamed Aymen MA Maaoui Sabri S Fennira Sana S Lobna Laroussi L Hassine Majed M Ouanes Sami S Mohamed Faouzi Drissi D Mallek Souad S Mahdhaoui Abdallah A Meriem Dghim D Jomaa Walid W Zayed Sofien S Kateb Tawfik T Bouchahda Nidhal N Azaiez Fares F Ben Salem Helmi H Marouen Morched M Noamen Aymen A Abdesselem Salem S Hichem Denguir D Ibn Hadj Amor Hassen H Abdeljelil Farhati F Amara Amine A Bejar Karim K Khaldoun Ben Hamda BH Hamza Chiheb C Ben Jamaa Mohsen M Fourati Sami S Elleuch Faycal F Grati Zeineb Z Chtourou Slim S Marouene Sami S Sahnoun Mohamed M Hadrich Morched M Mohamed Abdelkader Maalej M Bouraoui Hatem H Kamoun Kamel K Hadrich Moufid M Ben Chedli Tarek T Drissa Mohamed Akrem MA Charfeddine Hanene H Saadaoui Nizar N Achraf Gargouri G Ahmed Siala S Ayari Mokdad M Nabil Marsit M Mnif Sabeur S Sahnoun Maher M Kammoun Helmi H Ben Jemaa Khaled K Mostari Gharbi G Hamrouni Nebil N Yamen Maazoun M Ellouz Yassine Y Smiri Zahreddine Z Hdiji Amine A Bassem Jerbi J Ayadi Wacef W Zouari Amir A Abbassi Chedly C Fatma Boujelben Masmoudi BM Battikh Kais K Kharrat Elyes E Gtif Imen I Sami Milouchi M Bezdah Leila L Kachboura Salem S Maatouk Mohamed Faouzi MF Kraiem Sondes S Jeridi Gouider G Neffati Elyes E Kammoun Samir S Ben Ameur Youssef Y Fehri Wafa W Gamra Habib H Zakhama Lilia L Addad Faouzi F Mohamed Sami Mourali M Abid Leila L

JMIR research protocols 20220805 8

<h4>Background</h4>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.<h4>Objective</h4>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.<h4>Methods</h4>We will conduct a prospective multicentric observational st ...[more]

PMID: 35930353

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Project description:BACKGROUND:Atrial fibrillation (AF) is an important health problem in Tunisia. A significant change in the epidemiological pattern of heart disease has been seen in the last 3 decades; however, no large prospective multicenter trial reflecting national data has been published so far. Robust data on the contemporary epidemiological profile and management of AF patients in Tunisia are limited. OBJECTIVE:The aim of this study is to analyze, follow, and evaluate patients with AF in a large multicenter nationwide trial. METHODS:A total of 1800 consecutive patients with AF by electrocardiogram, reflecting all populations of all geographical regions of Tunisia, will be included in the study, with the objective of describing the epidemiological pattern of AF. Patients will be officially enrolled in the National Tunisian Registry of Atrial Fibrillation (NATURE-AF) only if an electrocardiogram diagnosis (12-lead, 24-hour Holter, or other electrocardiographic documentation) confirming AF is made. The qualifying episode of AF should have occurred within the last year, and patients do not need to be in AF at the time of enrollment. Patients will be followed for 1 year. Incidence of stroke or transient ischemic attack, thromboembolic events, and cardiovascular death will be recorded as the primary end point, and hemorrhagic accidents, measurement of international normalized ratio, and time in therapeutic range will be recorded as secondary end points. RESULTS:Results will be available at the end of the study; the demographic profile and general risk profile of Tunisian AF patients, frequency of anticoagulation, frequency of effective treatment, and risks of thromboembolism and bleeding will be evaluated according to the current guidelines. Major adverse events will be determined. NATURE-AF will be the largest registry for North African AF patients. CONCLUSIONS:This study would add data and provide a valuable opportunity for real-world clinical epidemiology in North African AF patients with insights into the uptake of contemporary AF management in this developing region. TRIAL REGISTRATION:ClinicalTrials.gov NCT03085576; https://clinicaltrials.gov/ct2/show/NCT03085576 (Archived by WebCite at http://www.webcitation.org/6zN2DN2QX). REGISTERED REPORT IDENTIFIER:RR1-10.2196/8523.

Dataset Information

Design and Rationale of the National Tunisian Registry of Percutaneous Coronary Intervention: Protocol for a Prospective Multicenter Observational Study.

Background

Objective

Methods

Results

Conclusions

Trial registration

International registered report identifier (irrid)

Publications

Design and Rationale of the National Tunisian Registry of Percutaneous Coronary Intervention: Protocol for a Prospective Multicenter Observational Study.

Similar Datasets

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