Clinical trial NCT03085576: NATional TUnisian REgistry of Atrial Fibrillation
Official title: National Tunisian Registry of Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
Anticoagulation
Stroke
Vitamin K antagonist
Cardioversion
INR (International Normalized Ratio)
Lead sponsor: Dacima Consulting
Sponsor class: OTHER
Collaborators: name: Société Tunisienne de Cardiologie & de Chirurgie Cardio-Vasculaire
First posted: 2017-03-21
Enrollment: 910
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with atrial fibrillation

Brief summary: A non-interventional, national longitudinal study of atrial fibrillation performed with 91 cardiologists.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* At least one episode of atrial fibrillation, documented on a 12-lead ECG and / or a rhythmic holter (duration of the episode: 30 seconds or more)
* Recent atrial fibrillation diagnosed for less than a year
* Regular monitoring every 3 months is ensured
* Informed, read and signed consent

Exclusion Criteria:

* Estimated life expectancy at less than 12 months
* Transient atrial fibrillation due to reversible cause (eg acute myocardial infarction, following cardiac surgery, acute alcohol intoxication, hyperthyroidism, pulmonary embolism or other acute pulmonary disease, pericarditis, myocarditis, hydro-electrolyte disorder, metabolic disorder)
* Cardiac surgery ≤ 3 months
* Atrial flutter isolated without atrial fibrillation
* Mental disorders
* Ongoing anticoagulation for reasons other than atrial fibrillation

Primary outcomes:
measure: Incidence of stroke or transient ischemic attack, thromboembolic events and cardiovascular death
timeFrame: Every 3 months up to 1 year
Secondary outcomes:
measure: Haemorrhagic accidents
timeFrame: Every 3 months up to 1 year
measure: Measurement of INR (International Normalized Ratio)
timeFrame: Every month for 1 year
measure: TTR (percent Time in Therapeutic INR Range)
timeFrame: 1 year
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: STCCCV - Société Tunisienne de Cardiologie et de Chirurgie Cardio-Vasculaire
Study officials:
affiliation: Société Tunisienne de Cardiologie et de Chirurgie Cardiovasculaire
name: Faouzi Addad, Professor
role: STUDY_CHAIR
References:
citation: Ben Halima A, Ouali S, Mourali MS, Chabrak S, Chettaoui R, Ben Halima M, Haggui A, Larbi N, Krichene S, Marrakchi S, Kacem S, Chrigui R, Abbes MF, Baccar H, Baraket N, Ben Halima N, Ben Khalfallah A, Ben Mbarek M, Ben Youssef S, Boughzala E, Boujnah MR, Drissa H, Gamra H, Gasmi A, Haouala H, Harrath Y, Issa I, Jeridi G, Kachboura S, Kammoun S, Kraiem S, Maatouk F, Milouchi S, Nasraoui W, Neji A, Sayahi K, Sdiri W, Smati W, Tlili S, Abid L, Abdesselem S, Zakhama L, Mahdhaoui A, Kammoun H, Ben Omrane S, Addad F. Design and Rationale of the National Tunisian Registry of Atrial Fibrillation: Protocol for a Prospective, Multicenter Trial. JMIR Res Protoc. 2018 Oct 15;7(10):e181. doi: 10.2196/resprot.8523.
citation: Ouali S, Ben Halima A, Chabrak S, Chettaoui R, Ben Halima M, Haggui A, Krichane S, Noureddine L, Marrakchi S, Charfeddine S, Hassine M, Sayahi K, Abbes Mohamed F, Nasraoui W, Ajmi H, Ben Miled M, Jebbari Z, Meghaieth MA, Allouche E, Mechmeche R, Zakhama L, Sdiri W, Ben Khalfallah A, Gharbi A, Milouchi S, Neji A, Antit S, Battikh K, Drissa M, Kaabachi S, Najar T, Tlili R, Chahbani I, Charfeddine H, Ben MM, Braham S, Maatouk F, Abdesselem S, Ayari M, Garbaa R, Hamrouni N, Mbarek D, Rekik H, Zaghdoudi H, Ayadi W, Baraket F, Ben Brahim K, Ben Romdhane M, Bousadia H, Brahim W, Mezri M, Guesmi A, Ounissi T, Kammoun S, Smati W, Tlili S, Zoughi K, Zemni J, Cheikh Bouhlel M, Islem S, Jemli R, Joulak A, Mzoughi K, Naanea H, Hached L, Hadrich M, Hmem M, Kacem S, Kammoun I, Othmani R, Ouerghi A, Abid S, Ennouri R, Haidar S, Heraiech S, Jammali M, Jarrar M, Riahi L, Trimech B, Azaiez MA, Azzouzi F, Ben Jemaa K, Ben Rejab O, Chrigui R, Wechtati W, Boughzela E, Jridi G, Bezdah L, Kraiem S, Drissa H, Ben Youssef S, Fehri W, Kachboura S, Gamra H, Kammoun S, Mourali MS, Addad F, Abid L. Epidemiological characteristics, management, and outcomes of atrial fibrillation in TUNISIA: Results from the National Tunisian Registry of Atrial Fibrillation (NATURE-AF). Clin Cardiol. 2021 Apr;44(4):501-510. doi: 10.1002/clc.23558. Epub 2021 Mar 11.