National Tunisian Registry of Percutaneous Coronary Intervention (NATURE-PCI)

The National Tunisian Registry of Percutaneous Coronary Intervention is an observational, prospective and multicenter study aiming to assess coronary intervention strategies in tunisian departments of cardiology. Cardiologists from both sectors (public and private) are participating in the study, with 37 investigational centers. Data will be captured electronically by DACIMA Clinical Suite, according to FDA 21 CFR part 11 (Food and Drug Administration 21 Code of Federal Regulations part 11), HIPAA (Health Insurance Portability and Accountability Act) & ICH (International Conference on Harmonisation) requirements.

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction; Myocardial Ischemia; ACS - Acute Coronary Syndrome; Angor Pectoris

• Study Type: Observational
• Enrollment (Actual): 2698

Contacts and Locations

Study Locations

• Tunisia
  • Tunis, Tunisia, 105
    • Société Tunisienne de Cardiologie & de Chirurgie Cardiovasculaire

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Tunisian patients needing percutaneous coronray intervention

Description

Inclusion Criteria:

• Tunisian patient needing PCI (Percutaneous Coronary Intervention) at the enrollment period
• Informed and signed consent

Exclusion Criteria:

• Withdrawn consent

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACE endopoint (Major adverse cardiovascular event)	Composite endpoint (MACE: major adverse cardiovascular event) : occurence of cardiovascular death, or non fatal myocardial infraction, or non fatal stroke, or Target Lesion revascularisation, or Target Vessel Revascularisation	Time-To-Event measure up to 12 months from baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death	Occurence of death incident (cardiovascular and non cardiovascular)	Time-To-Event measure up to 12 months from baseline
PCI (Percutaneous Coronary Intervention)	PCI (Percutaneous Coronary Intervention) complications: any side effect event occuring per or post cardiac intervention	Time-To-Event measure up to 12 months from baseline

Collaborators and Investigators

• Sponsor: Dacima Consulting
• Collaborators: Tunisian Society of Cardiology and Cardiovascular Surgery
• Investigators: Study Chair: Leila Abid, MD, Tunisian Society of Cardiology and Cardiovascular Surgery; Principal Investigator: Rania Hammami, MD, Tunisian Society of Cardiology and Cardiovascular Surgery

Publications and helpful links

General Publications

• Hammami R, Boudiche S, Rami T, Ben Halima N, Jamel A, Rekik B, Gribaa R, Imtinene BM, Charfeddine S, Ellouze T, Bahloul A, Hedi BS, Langar J, Ben Ahmed H, Ibn Elhadj Z, Hmam M, Ben Abdessalem MA, Maaoui S, Fennira S, Lobna L, Hassine M, Ouanes S, Mohamed Faouzi D, Mallek S, Mahdhaoui A, Meriem D, Jomaa W, Zayed S, Kateb T, Bouchahda N, Azaiez F, Ben Salem H, Marouen M, Noamen A, Abdesselem S, Hichem D, Ibn Hadj Amor H, Abdeljelil F, Amara A, Bejar K, Khaldoun BH, Hamza C, Ben Jamaa M, Fourati S, Elleuch F, Grati Z, Chtourou S, Marouene S, Sahnoun M, Hadrich M, Mohamed Abdelkader M, Bouraoui H, Kamoun K, Hadrich M, Ben Chedli T, Drissa MA, Charfeddine H, Saadaoui N, Achraf G, Ahmed S, Ayari M, Nabil M, Mnif S, Sahnoun M, Kammoun H, Ben Jemaa K, Mostari G, Hamrouni N, Yamen M, Ellouz Y, Smiri Z, Hdiji A, Bassem J, Ayadi W, Zouari A, Abbassi C, Fatma BM, Battikh K, Kharrat E, Gtif I, Sami M, Bezdah L, Kachboura S, Maatouk MF, Kraiem S, Jeridi G, Neffati E, Kammoun S, Ben Ameur Y, Fehri W, Gamra H, Zakhama L, Addad F, Mohamed Sami M, 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 Aug 5;11(8):e24595. doi: 10.2196/24595.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 30, 2020
• Primary Completion (ACTUAL): December 31, 2021
• Study Completion (ACTUAL): March 30, 2022

Study Registration Dates

• First Submitted: January 5, 2020
• First Submitted That Met QC Criteria: January 5, 2020
• First Posted (ACTUAL): January 7, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 4, 2022
• Last Update Submitted That Met QC Criteria: April 1, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: PCI; ACS; MI
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Myocardial Infarction; Infarction; Myocardial Ischemia; Ischemia; Acute Coronary Syndrome; Angina Pectoris
• Other Study ID Numbers: DAC-009-NATUREPCI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No