Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2022 Aug 5;11(8):e24595.
doi: 10.2196/24595.

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

Rania Hammami  1 , Selim Boudiche  2 , Tlili Rami  3 , Nejeh Ben Halima  4 , Ahmed Jamel  4 , Bassem Rekik  2 , Rym Gribaa  5 , Ben Mrad Imtinene  6 , Salma Charfeddine  1 , Tarek Ellouze  1 , Amine Bahloul  1 , Ben Slima Hédi  7 , Jamel Langar  8 , Habib Ben Ahmed  9 , Zied Ibn Elhadj  10 , Mohamed Hmam  8 , Mohamed Aymen Ben Abdessalem  11 , Sabri Maaoui  12 , Sana Fennira  6 , Laroussi Lobna  10 , Majed Hassine  13 , Sami Ouanes  13 , Drissi Mohamed Faouzi  8 , Souad Mallek  1 , Abdallah Mahdhaoui  11 , Dghim Meriem  14 , Walid Jomaa  15 , Sofien Zayed  3 , Tawfik Kateb  8 , Nidhal Bouchahda  13 , Fares Azaiez  3 , Helmi Ben Salem  16 , Morched Marouen  17 , Aymen Noamen  14 , Salem Abdesselem  8 , Denguir Hichem  18 , Hassen Ibn Hadj Amor  19 , Farhati Abdeljelil  2 , Amine Amara  17 , Karim Bejar  20 , Ben Hamda Khaldoun  15 , Chiheb Hamza  8 , Mohsen Ben Jamaa  21 , Sami Fourati  17 , Faycal Elleuch  17 , Zeineb Grati  8 , Slim Chtourou  17 , Sami Marouene  8 , Mohamed Sahnoun  17 , Morched Hadrich  17 , Maalej Mohamed Abdelkader  17 , Hatem Bouraoui  11 , Kamel Kamoun  8 , Moufid Hadrich  8 , Tarek Ben Chedli  8 , Mohamed Akrem Drissa  8 , Hanene Charfeddine  17 , Nizar Saadaoui  17 , Gargouri Achraf  8 , Siala Ahmed  17 , Mokdad Ayari  8 , Marsit Nabil  8 , Sabeur Mnif  17 , Maher Sahnoun  17 , Helmi Kammoun  17 , Khaled Ben Jemaa  21 , Gharbi Mostari  22 , Nebil Hamrouni  21 , Maazoun Yamen  17 , Yassine Ellouz  8 , Zahreddine Smiri  8 , Amine Hdiji  17 , Jerbi Bassem  17 , Wacef Ayadi  17 , Amir Zouari  17 , Chedly Abbassi  8 , Boujelben Masmoudi Fatma  17 , Kais Battikh  21 , Elyes Kharrat  17 , Imen Gtif  14 , Milouchi Sami  19 , Leila Bezdah  9 , Salem Kachboura  11 , Mohamed Faouzi Maatouk  15 , Sondes Kraiem  6 , Gouider Jeridi  11 , Elyes Neffati  5 , Samir Kammoun  1 , Youssef Ben Ameur  3 , Wafa Fehri  14 , Habib Gamra  13 , Lilia Zakhama  14 , Faouzi Addad  10 , Mourali Mohamed Sami  2 , Leila Abid  1
Affiliations

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

Rania Hammami et al. JMIR Res Protoc. .

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.

Keywords: 1-year outcome; Tunisia; artery disease; coronary; multicentric; national; percutaneous; percutaneous coronary intervention; registry.

PubMed Disclaimer

Conflict of interest statement

Conflicts of Interest: None declared.

Figures

Figure 1
Figure 1
Repartition of the investigating centers in this study.
See this image and copyright information in PMC

References

    1. Ritchie H, Roser M. Causes of death. Our World in Data. 2018. Feb 14, [2020-05-12]. https://ourworldindata.org/causes-of-death .
    1. Jemaa R, Razgallah R, Ben Ghorbel I, Rais L, Kallel A. Prevalence of cardiovascular risk factors in the Tunisian population: The ATERA-survey. Archives of Cardiovascular Diseases Supplements. 2020 Jan;12(1):159. doi: 10.1016/j.acvdsp.2019.09.328. - DOI
    1. Fokkema ML, James SK, Albertsson P, Aasa M, Åkerblom Axel, Calais F, Eriksson P, Jensen J, Schersten F, de Smet BJ, Sjögren Iwar, Tornvall P, Lagerqvist B. Outcome after percutaneous coronary intervention for different indications: long-term results from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR) EuroIntervention. 2016 Jun 20;12(3):303–11. doi: 10.4244/EIJY15M10_07. http://www.pcronline.com/eurointervention/100th_issue/50 20140421-05 - DOI - PubMed
    1. Wijns W, Barbato E. Let's talk BIG DATA. EuroIntervention. 2016 Oct 20;12(9):1081–1082. doi: 10.4244/EIJV12I9A177. http://www.pcronline.com/eurointervention/106th_issue/177 EIJV12I9A177 - DOI - PubMed
    1. Levine GN, Bates ER, Blankenship JC, Bailey SR, Bittl JA, Cercek B, Chambers CE, Ellis SG, Guyton RA, Hollenberg SM, Khot UN, Lange RA, Mauri L, Mehran R, Moussa ID, Mukherjee D, Nallamothu BK, Ting HH, ACCF. AHA. SCAI 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention: executive summary: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions. Catheter Cardiovasc Interv. 2012 Feb 15;79(3):453–95. doi: 10.1002/ccd.23438. - DOI - PubMed

Associated data