TY  - JOUR
AU  - Ben Halima, Afef
AU  - Ouali, Sana
AU  - Mourali, Mohamed Sami
AU  - Chabrak, Sonia
AU  - Chettaoui, Rafik
AU  - Ben Halima, Manel
AU  - Haggui, Abdeddayem
AU  - Larbi, Noureddine
AU  - Krichène, Salma
AU  - Marrakchi, Sonia
AU  - Kacem, Slim
AU  - Chrigui, Rim
AU  - Abbes, Mohamed Fahmi
AU  - Baccar, Hédi
AU  - Baraket, Nadia
AU  - Ben Halima, Najeh
AU  - Ben Khalfallah, Ali
AU  - Ben Mbarek, Mohamed
AU  - Ben Youssef, Soraya
AU  - Boughzala, Essia
AU  - Boujnah, Mohamed Rachid
AU  - Drissa, Habiba
AU  - Gamra, Habib
AU  - Gasmi, Ali
AU  - Haouala, Habib
AU  - Harrath, Youssef
AU  - Issa, Ines
AU  - Jeridi, Gouider
AU  - Kachboura, Salem
AU  - Kammoun, Samir
AU  - Kraiem, Sondes
AU  - Maatouk, Faouzi
AU  - Milouchi, Sami
AU  - Nasraoui, Wided
AU  - Neji, Ali
AU  - Sayahi, Khaled
AU  - Sdiri, Wissem
AU  - Smati, Wajih
AU  - Tlili, Samir
AU  - Abid, Leila
AU  - Abdesselem, Salem
AU  - Zakhama, Lilia
AU  - Mahdhaoui, Abdallah
AU  - Kammoun, Helmi
AU  - Ben Omrane, Skander
AU  - Addad, Faouzi
PY  - 2018
DA  - 2018/10/15
TI  - Design and Rationale of the National Tunisian Registry of Atrial Fibrillation: Protocol for a Prospective, Multicenter Trial
JO  - JMIR Res Protoc
SP  - e181
VL  - 7
IS  - 10
KW  - atrial fibrillation
KW  - registry
KW  - North African
KW  - NATURE-AF
AB  - Background: Atrial fibrillation (AF) is an important health problem in Tunisia. A significant change in the epidemiological pattern of heart disease has been seen in the last 3 decades; however, no large prospective multicenter trial reflecting national data has been published so far. Robust data on the contemporary epidemiological profile and management of AF patients in Tunisia are limited. Objective: The aim of this study is to analyze, follow, and evaluate patients with AF in a large multicenter nationwide trial. Methods: A total of 1800 consecutive patients with AF by electrocardiogram, reflecting all populations of all geographical regions of Tunisia, will be included in the study, with the objective of describing the epidemiological pattern of AF. Patients will be officially enrolled in the National Tunisian Registry of Atrial Fibrillation (NATURE-AF) only if an electrocardiogram diagnosis (12-lead, 24-hour Holter, or other electrocardiographic documentation) confirming AF is made. The qualifying episode of AF should have occurred within the last year, and patients do not need to be in AF at the time of enrollment. Patients will be followed for 1 year. Incidence of stroke or transient ischemic attack, thromboembolic events, and cardiovascular death will be recorded as the primary end point, and hemorrhagic accidents, measurement of international normalized ratio, and time in therapeutic range will be recorded as secondary end points. Results: Results will be available at the end of the study; the demographic profile and general risk profile of Tunisian AF patients, frequency of anticoagulation, frequency of effective treatment, and risks of thromboembolism and bleeding will be evaluated according to the current guidelines. Major adverse events will be determined. NATURE-AF will be the largest registry for North African AF patients. Conclusions: This study would add data and provide a valuable opportunity for real-world clinical epidemiology in North African AF patients with insights into the uptake of contemporary AF management in this developing region. Trial Registration: ClinicalTrials.gov NCT03085576; https://clinicaltrials.gov/ct2/show/NCT03085576 (Archived by WebCite at http://www.webcitation.org/6zN2DN2QX) Registered Report Identifier: RR1-10.2196/8523 
SN  - 1929-0748
UR  - http://www.researchprotocols.org/2018/10/e181/
UR  - https://doi.org/10.2196/resprot.8523
UR  - http://www.ncbi.nlm.nih.gov/pubmed/30322836
DO  - 10.2196/resprot.8523
ID  - info:doi/10.2196/resprot.8523
ER  -