National Tunisian Clinical Registry on CardioVascular Secondary Prevention Clinical

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-09

Study Completion Date

2025-07-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Secondary Prevention CHD CV Risk

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Coronary Event

Patient with any coronary event

No interventions assigned to this group

Eligibility Criteria

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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