NATional TUnisian REgistry of Atrial Fibrillation

NCT03085576 | Completed DMC

• 1 other identifier: DAC-001-NATUREAF
• Study Type: observational
• Target: 910
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation; Anticoagulation; Stroke; Vitamin K antagonist; Cardioversion; INR (International Normalized Ratio)

Outcome Measures

Primary Outcomes (1)

• 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

  Every 3 months up to 1 year

Secondary Outcomes (3)

• Haemorrhagic accidents

  Every 3 months up to 1 year

• Measurement of INR (International Normalized Ratio)

  Every month for 1 year

• TTR (percent Time in Therapeutic INR Range)

  1 year

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with atrial fibrillation

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dacima Consulting: lead
• Société Tunisienne de Cardiologie & de Chirurgie Cardio-Vasculaire: collaborator

Study Sites (1)

STCCCV - Société Tunisienne de Cardiologie et de Chirurgie Cardio-Vasculaire

Tunis, 1053, Tunisia

Location

Related Publications (2)

• 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.

  PMID: 30322836 BACKGROUND

• 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.

  PMID: 33704830 BACKGROUND

Related Links

• Medscape : A first register on AF in the Maghreb

MeSH Terms

Conditions

Atrial Fibrillation; Stroke

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Study Officials

• Faouzi Addad, Professor

  Société Tunisienne de Cardiologie et de Chirurgie Cardiovasculaire

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2017
• First Posted: March 21, 2017
• Study Start: March 1, 2017
• Primary Completion: May 30, 2018
• Study Completion: July 30, 2018
• Last Updated: April 29, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)