The Jordan Atrial Fibrillation Study: Baseline Risk Scores and One Year Outcome

Atrial Fibrillation Clinical Trial

Official title:

The Baseline Features and CHA2DS2 VASc /HAS BLED Scores of Jordanian Patients With Atrial Fibrillation and the One Year Outcome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03917992
• Other study ID #: JOAF1Y
• Status: Completed
• Start date: May 25, 2019
• Est. completion date: November 25, 2021

Study information

• Verified date: May 2023
• Source: Jordan Collaborating Cardiology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2020
• Est. completion date: November 25, 2021
• Est. primary completion date: November 25, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
Jordan	Ep Clinics Khalidi S	Amman
Jordan	Integrated Center for Cardiovascular and Electric Diseases	Amman
Jordan	Istishari Hospital	Amman
Jordan	Jordan Hospital	Amman
Jordan	Khalidi Hospital & Medical Center	Amman
Jordan	Specialty Hospital	Amman
Jordan	The University of Jordan	Amman
Jordan	King Abdullah University Hospital	Irbid

Sponsors (1)

Lead Sponsor	Collaborator
Ayman J Hammoudeh, MD, FACC

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stroke and systemic embolization at one year	Stroke that develops from enrollment to one year of follow up (Scale: 0= no stroke at one year, 1= stroke at one year). Systemic embolization that develops in any arterial bed other than the brain from enrollment to one year of follow up (Scale: no systemic embolization at one year =0, systemic embolization at one year=1)	one year
Primary	Major bleeding events at one year	Major bleeding events from enrollment to one year of follow up including: intracranial bleeding (scale: present= 1, absent=0), hospitalization for bleeding (scale: present=1, absent=2), hemoglobin decrease more than 2 gm/dL (scale: 1=present, 2=absent), and /or transfusion (scale: 1=present, 0=absent).	one year