A non-interventional, national longitudinal study of atrial fibrillation performed with 91 cardiologists.
The NATURE-AF study is carried out in Tunisia at cardiology consultations in hospitals and in the liberal sector. A total of 91 cardiologists participate in the selection of patients as investigators. The study is a longitudinal non-interventional registry of atrial fibrillation. 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 Type
OBSERVATIONAL
Enrollment
910
STCCCV - Société Tunisienne de Cardiologie et de Chirurgie Cardio-Vasculaire
Tunis, Tunisia
Incidence of stroke or transient ischemic attack, thromboembolic events and cardiovascular death
Number of patients with ischemic stroke and/or transient ischemic attack, and/or arterial embolization during the follow-up period
Time frame: Every 3 months up to 1 year
Haemorrhagic accidents
All bleeding events (digestive, cerebral, other locations)
Time frame: Every 3 months up to 1 year
Measurement of INR (International Normalized Ratio)
INR measurement of venous blood sampling
Time frame: Every month for 1 year
TTR (percent Time in Therapeutic INR Range)
The mean TTR obtained in patients who received anticoagulant therapy
Time frame: 1 year
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