National Tunisian Registry of Percutaneous Coronary Intervention

Completed

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

• Registration Number: NCT04219761
• Lead Sponsor: Dacima Consulting

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-05
• Study First Submitted QC: 2020-01-05
• Study First Posted: 2020-01-07
• Study Start: 2020-01-30
• Primary Completion: 2021-12-31
• Study Completion: 2022-03-30
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-01
• Last Update Posted: 2022-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2698

Inclusion Criteria

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

Exclusion Criteria

• Withdrawn consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MACE endopoint (Major adverse cardiovascular event)	Time-To-Event measure up to 12 months from baseline	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Société Tunisienne de Cardiologie & de Chirurgie Cardiovasculaire; 🇹🇳 Tunis, Tunisia