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Accepted for/Published in: JMIR Research Protocols

Date Submitted: Sep 30, 2020
Date Accepted: Oct 12, 2021

The final, peer-reviewed published version of this preprint can be found here:

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

Hammami R, Boudiche S, Tlili R, Ben Hlima N, Jamel A, Rekik B, Gribaa R, Ben Mrad I, Charfeddine S, Ellouz T, Bahloul A, Ben Slima H, Langar J, Ben Ahmed H, Ibn Bel Hadj Z, Hmem M, Ben Abdessalem MA, Maaoui S, Fennira S, Laroussi L, Hassine M, Ouannes S, Drissi F, Mallek S, Mahdhaoui A, Dghim M, Jomaa W, Zayed S, Kateb T, Bouchahda N, Azaiez F, Ben Salem H, Marouene M, Noamen A, Abdesselem S, Denguir HD, Hadj Amor H, Farhati A, Amara A, Bejjar K, Ben Hamda K, Hamza C, Ben Jemaa M, Fourati S, Elleuch F, Grati Z, Chtourou S, Marouene S, Sahnoun M, Hadrich M, Maalej A, Bouraoui H, Kamoun K, Hadrich M, Ben Chedli T, Drissa MA, Charfeddine H, Saadaoui N, Gargouri A, Siala A, Ayari M, Marsit N, Mnif S, Sahnoun M, Kamoun H, Ben Jemaa K, Gharbi M, Hamrouni N, Maazoun Y, Ellouz Y, Smiri Z, Hadiji A, Jerbi B, Ayadi W, Zouari A, Abbassi C, Boujelben Masmoudi F, Battikh K, Kharrat E, Mnif S, Gtif I, Milouchi S, Bezdah L, Kachboura S, Maatoug F, Kraiem S, Jeridi G, Nafati E, Kammoun S, Ben Ameur Y, Fehri Siala W, Gamra H, Zakhama L, Addad F, Mourali MS, Abid L

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

JMIR Res Protoc 2022;11(8):e24595

DOI: 10.2196/24595

PMID: 35930353

PMCID: 9391981

Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.

Design and Rationale of the National Tunisian Registry of Percutaneous coronary Intervention: Protocol for a Prospective, Multicenter Trial

  • Rania Hammami; 
  • Slim Boudiche; 
  • Rami Tlili; 
  • Nejeh Ben Hlima; 
  • Ahmed Jamel; 
  • Bassem Rekik; 
  • Rym Gribaa; 
  • Imtinen Ben Mrad; 
  • Selma Charfeddine; 
  • Tarek Ellouz; 
  • Amin Bahloul; 
  • Hedi Ben Slima; 
  • Jamel Langar; 
  • Habib Ben Ahmed; 
  • Zied Ibn Bel Hadj; 
  • Mohamed Hmem; 
  • Mohamed Aymen Ben Abdessalem; 
  • Sabri Maaoui; 
  • Sana Fennira; 
  • Lobna Laroussi; 
  • Majed Hassine; 
  • Sami Ouannes; 
  • Faouzi Drissi; 
  • Souad Mallek; 
  • Abdallah Mahdhaoui; 
  • Mariem Dghim; 
  • Walid Jomaa; 
  • Sofiene Zayed; 
  • Tawfik Kateb; 
  • Nidhal Bouchahda; 
  • Fares Azaiez; 
  • Helmi Ben Salem; 
  • Morched Marouene; 
  • Aymen Noamen; 
  • Salem Abdesselem; 
  • Hichem Denguir Denguir; 
  • Hassen Hadj Amor; 
  • Abdeljelil Farhati; 
  • Amine Amara; 
  • Karim Bejjar; 
  • Khaldoun Ben Hamda; 
  • Chiheb Hamza; 
  • Mohsen Ben Jemaa; 
  • Sami Fourati; 
  • Faycal Elleuch; 
  • Zeineb Grati; 
  • Slim Chtourou; 
  • Sami Marouene; 
  • Mohamed Sahnoun; 
  • Morched Hadrich; 
  • Abdelkader Maalej; 
  • Hatem Bouraoui; 
  • Kamel Kamoun; 
  • Moufid Hadrich; 
  • Tarek Ben Chedli; 
  • Mohamed Akrem Drissa; 
  • Hanene Charfeddine; 
  • Nizar Saadaoui; 
  • Achraf Gargouri; 
  • Ahmed Siala; 
  • Mokdad Ayari; 
  • Nabil Marsit; 
  • Sabeur Mnif; 
  • Maher Sahnoun; 
  • Helmi Kamoun; 
  • Khaled Ben Jemaa; 
  • Mostari Gharbi; 
  • Nebil Hamrouni; 
  • Yamen Maazoun; 
  • Yassine Ellouz; 
  • Zahreddine Smiri; 
  • Amin Hadiji; 
  • Bassem Jerbi; 
  • Wacef Ayadi; 
  • Amir Zouari; 
  • Chedly Abbassi; 
  • Fatma Boujelben Masmoudi; 
  • Kais Battikh; 
  • Elyes Kharrat; 
  • Sabeur Mnif; 
  • Imen Gtif; 
  • Sami Milouchi; 
  • Leila Bezdah; 
  • Salem Kachboura; 
  • Faouzi Maatoug; 
  • Sondes Kraiem; 
  • Gouider Jeridi; 
  • Elyes Nafati; 
  • Samir Kammoun; 
  • Youssef Ben Ameur; 
  • Wafa Fehri Siala; 
  • Habib Gamra; 
  • Lilia Zakhama; 
  • Faouzi Addad; 
  • Mohamed Sami Mourali; 
  • Leila Abid

ABSTRACT

Background:

Coronary diseases remain the first cause of death in the world; the management of this condition has improved, thanks to new technical tools and multicentric registries. Recently in Tunisia, the number of intervention procedures has markedly increased, giving the explosion of cardiovascular risk factors among Tunisian people.

Objective:

The aim of the study was to investigate the in-hospital and one-year clinical outcome of patients treated with percutaneous coronary intervention (PCI) in Tunisia.

Methods:

We will conduct a prospective, multicentric, observational study including patients > 18 year-old who underwent a PCI between 31January and 30 June 2020. The primary end point are the occurrence of a major adverse cardiovascular event , defined as cardiovascular death, myocardial infarction, cerebrovascular accident, and target vessel revascularization with either repeat PCI or coronary artery bypass surgery (CABG). Secondary end-points consist in procedural success rate, stent thrombosis, and the rate of redo-PCI/CABG for in-stent restenosis.

Results:

Results will be available at the end of the study as well as the demographic profile and general risk profile of Tunisian patients undergoing PCI. The complexity level of procedures, as left main, bifurcation, chronic occlusion PCI will be analyzed and immediate as well as long term results will be determined. NATURE-PCI will be the first national multicentric registry of angioplasty in Africa.

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 contemporary coronary artery disease in this developing region. Clinical Trial: clinicaltrials.gov


 Citation

Please cite as:

Hammami R, Boudiche S, Tlili R, Ben Hlima N, Jamel A, Rekik B, Gribaa R, Ben Mrad I, Charfeddine S, Ellouz T, Bahloul A, Ben Slima H, Langar J, Ben Ahmed H, Ibn Bel Hadj Z, Hmem M, Ben Abdessalem MA, Maaoui S, Fennira S, Laroussi L, Hassine M, Ouannes S, Drissi F, Mallek S, Mahdhaoui A, Dghim M, Jomaa W, Zayed S, Kateb T, Bouchahda N, Azaiez F, Ben Salem H, Marouene M, Noamen A, Abdesselem S, Denguir HD, Hadj Amor H, Farhati A, Amara A, Bejjar K, Ben Hamda K, Hamza C, Ben Jemaa M, Fourati S, Elleuch F, Grati Z, Chtourou S, Marouene S, Sahnoun M, Hadrich M, Maalej A, Bouraoui H, Kamoun K, Hadrich M, Ben Chedli T, Drissa MA, Charfeddine H, Saadaoui N, Gargouri A, Siala A, Ayari M, Marsit N, Mnif S, Sahnoun M, Kamoun H, Ben Jemaa K, Gharbi M, Hamrouni N, Maazoun Y, Ellouz Y, Smiri Z, Hadiji A, Jerbi B, Ayadi W, Zouari A, Abbassi C, Boujelben Masmoudi F, Battikh K, Kharrat E, Mnif S, Gtif I, Milouchi S, Bezdah L, Kachboura S, Maatoug F, Kraiem S, Jeridi G, Nafati E, Kammoun S, Ben Ameur Y, Fehri Siala W, Gamra H, Zakhama L, Addad F, Mourali MS, Abid L

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

JMIR Res Protoc 2022;11(8):e24595

DOI: 10.2196/24595

PMID: 35930353

PMCID: 9391981

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