CHD, CV Risk, Secondary Prevention
Conditions
Keywords
Secondary Prevention, STCCCV, CHD, CV Risk
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.
Interventions
None listed
Sponsors
Dacima Consulting
Tunisian Society of Cardiology and Cardiovascular Surgery
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compliance | From enrollment to the end of the follow-up (12 months) | Number of subjects with sufficient adherence to their cardiovascular medication |
Countries
Tunisia
Contacts
STUDY_CHAIRYoussef Ben Ameur, MD
Tunisian Society of Cardiology and Cardiovascular Surgery
STUDY_CHAIRSalma Charfeddine, MD
Tunisian Society of Cardiology and Cardiovascular Surgery
STUDY_CHAIRIhsen Zairi, MD
Tunisian Society of Cardiology and Cardiovascular Surgery
Outcome results
None listed