National Tunisian Clinical Registry on CardioVascular Secondary Prevention Clinical

Recruiting

• Conditions: Secondary Prevention; CHD; CV Risk

• Registration Number: NCT07034274
• Lead Sponsor: Dacima Consulting

Brief Summary

A non-interventional, national longitudinal multicenter study of CV secondary prevention in Tunisia

Detailed Description

The NATURE-STOP-CHD study is carried out in Tunisia at cardiology consultations in hospitals and in the liberal sector. The study is a longitudinal non-interventional registry of patient undergoing secondary CV prevention. The data collected are managed by the DACIMA Clinical Suite® platform, which complies with international standards: FDA 21 CFR part 11 (Food and Drug Administration 21 Code of Federal Regulations part 11), HIPPA (Health Insurance Portability and Accountability Act), ICH (International Conference on Harmonisation), MedDRA (Medical Dictionary for Regulatory Activities). The DACIMA Clinical Suite® platform allows to track the data entered, check for inconsistencies and missing data, and schedule monitoring visits. A Steering Committee is set up to monitor patient inclusions, verify data sources, perform audit trails and prepare the statistical analysis plan for the study.

Study Timeline

• Status Verified: 2025-06
• Study Start: 2025-06-09
• Study First Submitted: 2025-06-15
• Study First Submitted QC: 2025-06-15
• Last Update Submitted: 2025-06-15
• Study First Posted: 2025-06-24
• Last Update Posted: 2025-06-24
• Primary Completion: 2025-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

• Age > 18 years and < 80 years
• Patients who have been hospitalized for at least one acute coronary event with coronary revascularization, either percutaneous or surgical by coronary artery bypass grafting, or who have confirmed coronary artery disease requiring optimal medical treatment for more than 6 months
• Coronary event happening in 2024
• Informed, read and signed consent

Exclusion Criteria

• Familial hypercholesterolemia

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Compliance	From enrollment to the end of the follow-up (12 months)	Number of subjects with sufficient adherence to their cardiovascular medication

Trial Locations

Locations (1)

Tunisian Society of Cardiology and Cardiovascular Surgery; 🇹🇳 Tunis, Tunisia