Clinical trial NCT03917992: The Jordan Atrial Fibrillation Study: Baseline Risk Scores and One Year Outcome
Official title: The Baseline Features and CHA2DS2 VASc /HAS BLED Scores of Jordanian Patients With Atrial Fibrillation and the One Year Outcome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: Atrial fibrillation
Lead sponsor: Jordan Collaborating Cardiology Group
Sponsor class: OTHER
First posted: 2019-04-17
Enrollment: 2020
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive admissions aged 18+ years with new onset or known AF Admitted to participating hospitals

Brief summary: The Jordanian AF study, the first of its kind in Jordan, will evaluate patients with AF in an in-patient and out-patient settings. The morbidity and mortality associated with AF has not been studied in this region especially with the relation to the HAD BLED and CHADS VAC score.

Detailed description: The investigators are introducing The Jordan Atrial Fibrillation Study: Baseline Risk Scores and One Year Outcome" which is an investigator initiated, prospective, non interventional, observational study.

Medical research and clinical studies in Jordan are two basic responsibilities of all medical sectors in the country. Despite the drastic growth and advances of the medical services, the volume of the local medical research is, at best estimate, scarce. The emerging role of private medical groups, in cooperation with other medical sectors and medical schools, in conducting, presenting, and publishing such studies should be encouraged and welcomed by the other medical sectors in the country. A major indicator of judging the credibility and quality of any medical research project is to look at the conferences the research was presented at and the journals it was published in.

This is the 9th major project of the Jordan Collaborating Cardiology Group (JCC) in collaboration with the Jordan AF Study Group. (see Appendix 2. Timeline of our studies) The first project was JoHARTS (1-5) that evaluated coronary risk factors and dyslipidemia in 5000 individuals with ACS, stable CAD, and non CAD patients. The 2nd project was CAPRIS (6,7) evaluated the prognostic implications of hs-CRP in ACS from admission to 1 year. The 3rd project was MINTOR that evaluated onset, triggers, reperfusion strategies and hospital mortality in more than 950 Jordanians with acute ST elevation MI (8-10). The 4th project was GLORY study that evaluated the prevalence of glucometabolic states among ACS patients, prognosis up to 1 year, and TIMI risk score (11-15). The 5th was JoPCR1 that evaluated outcome post PCI in 2426 ACS and non ACS patients in 12 tertiary care centers for the incidence of death, stent thrombosis, revascularization, bleeding, impact of gender, DM, renal dysfunction and age on outcome, GRACE and CRUSADE risk scores (16-18). The 6th is the colchicine study of AF prevention in open heart surgery, one is completed with 1 mg dose and one is ongoing with reduced dose (19). The 7th and 8th projects are ongoing and study statin eligibility in patients admitted with MI (Statin EPIC) and decade or more survivors after coronary revascularization.

The Jordanian AF study, the first of its kind in Jordan, will evaluate patients with AF in an in-patient and out-patient settings.

Study Objectives

1. To study the demographic baseline features of AF patients, risk factors, and comorbid diseases, and types of AF.
2. To study CHADS2 VA2Sc score and HAS BLED scores in these patients.
3. To study patterns of treatment of AF, especially the use of oral anticoagulation and concomitant antiplatelet therapy.
4. To study 1 year incidence of stroke and systemic embolization and other cardiovascular events up to one year of follow up.
5. To present these findings in regional and international conferences and publish them.

The study PI is Dr Nazih Kadri. The assistant to the PI is Dr Eisa Ghanma. The director of the proceedings is Dr A Hammoudeh, and the assistant to the study director, Dr Ahmad Tamari will aid in study clinical initiation, clinical form development, analysis of data and manuscript writing along with the whole team of PI, Co PI, study director and other investigators.

Eligibility criteria: Inclusion Criteria:

* Age 18 years or above
* Admission with atrial fibrillation or clinic visit for atrial fibrillation
* Signing the consent form

Exclusion Criteria:

* Age less than 18 years
* Refusal of signing the censent form
* Grave systemic disease with high probability of in hospital death

Primary outcomes:
measure: Stroke and systemic embolization at one year
timeFrame: one year
measure: Major bleeding events at one year
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Istishari Hospital
city: Amman
country: Jordan
facility: The University of Jordan
city: Amman
country: Jordan
facility: Ep Clinics Khalidi S
city: Amman
country: Jordan
facility: Integrated Center for Cardiovascular and Electric Diseases
city: Amman
country: Jordan
facility: Jordan Hospital
city: Amman
country: Jordan
facility: Khalidi Hospital & Medical Center
city: Amman
country: Jordan
facility: Specialty Hospital
city: Irbid
country: Jordan
facility: King Abdullah University Hospital
Study officials:
affiliation: Cardiology Dept, Istishari Hospital, Amman, Jordan
name: Ayman Hammoudeh, MD, FACC
role: STUDY_CHAIR
References:
citation: Al-Makhamreh H, Alrabadi N, Haikal L, Krishan M, Al-Badaineh N, Odeh O, Barqawi T, Nawaiseh M, Shaban A, Abdin B, Khamies L, Hammoudeh A. Paroxysmal and Non-Paroxysmal Atrial Fibrillation in Middle Eastern Patients: Clinical Features and the Use of Medications. Analysis of the Jordan Atrial Fibrillation (JoFib) Study. Int J Environ Res Public Health. 2022 May 19;19(10):6173. doi: 10.3390/ijerph19106173.
citation: Alhaddad Z, Hammoudeh A, Khader Y, Alhaddad IA. Demographics and Risk Profile of Elderly Middle Eastern Patients with Atrial Fibrillation: The Jordan Atrial Fibrillation (JoFib) Study. Vasc Health Risk Manag. 2022 Apr 15;18:289-295. doi: 10.2147/VHRM.S360822. eCollection 2022.
citation: Hammoudeh AJ, Khader Y, Kadri N, Al-Mousa E, Badaineh Y, Habahbeh L, Tabbalat R, Janabi H, Alhaddad IA. Adherence to the 2019 AHA/ACC/HRS Focused Update of the 2014 AHA/ACC/HRS Guideline on the Use of Oral Anticoagulant Agents in Middle Eastern Patients with Atrial Fibrillation: The Jordan Atrial Fibrillation (JoFib) Study. Int J Vasc Med. 2021 Apr 8;2021:5515089. doi: 10.1155/2021/5515089. eCollection 2021.