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NCT04219761 Clinical Trial

National Tunisian Registry of Percutaneous Coronary Intervention

Myocardial Infarction Clinical Trial

— NATURE-PCI  

Official title:
National Tunisian Registry of Percutaneous Coronary Intervention

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04219761
Other study ID # DAC-009-NATUREPCI
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 30, 2020
Est. completion date March 30, 2022

Study information
Verified date April 2022
Source Dacima Consulting
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 2698
Est. completion date March 30, 2022
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Tunisian patient needing PCI (Percutaneous Coronary Intervention) at the enrollment period - Informed and signed consent Exclusion Criteria: - Withdrawn consent

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Tunisia Société Tunisienne de Cardiologie & de Chirurgie Cardiovasculaire Tunis

Sponsors (2)
Lead Sponsor Collaborator
Dacima Consulting Tunisian Society of Cardiology and Cardiovascular Surgery

Country where clinical trial is conducted

Tunisia, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Death Occurence of death incident (cardiovascular and non cardiovascular) Time-To-Event measure up to 12 months from baseline
Secondary 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
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