National Tunisian Clinical Registry on CardioVascular Secondary Prevention Clinical (NATURE STOP-CH)

DACIMA

Status: Enrolling

Conditions: CV Risk; CHD; Secondary Prevention

Study type: Observational

Funder types: Other

Identifiers

NCT07034274

DAC-017-NATURE STOP-CHD

Details and patient eligibility

About

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

Full 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.

Enrollment: 5,000 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

5,000 participants in 1 patient group

Coronary Event

Description:

Patient with any coronary event