The Jordan Atrial Fibrillation Study: Baseline Risk Scores and One Year Outcome
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|ClinicalTrials.gov Identifier: NCT03917992|
Recruitment Status : Recruiting
First Posted : April 17, 2019
Last Update Posted : June 25, 2019
|Condition or disease|
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.
- To study the demographic baseline features of AF patients, risk factors, and comorbid diseases, and types of AF.
- To study CHADS2 VA2Sc score and HAS BLED scores in these patients.
- To study patterns of treatment of AF, especially the use of oral anticoagulation and concomitant antiplatelet therapy.
- To study 1 year incidence of stroke and systemic embolization and other cardiovascular events up to one year of follow up.
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||The Baseline Features and CHA2DS2 VASc /HAS BLED Scores of Jordanian Patients With Atrial Fibrillation and the One Year Outcome|
|Actual Study Start Date :||May 25, 2019|
|Estimated Primary Completion Date :||May 25, 2021|
|Estimated Study Completion Date :||May 15, 2022|
- Stroke and systemic embolization at one year [ Time Frame: 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)
- Major bleeding events at one year [ Time Frame: 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03917992
|Contact: Nazih Kadri, MD, FACCemail@example.com|
|Contact: Ayman J Hammoudeh, MD, FACC||0096265001000 ext firstname.lastname@example.org|
|Amman, Jordan, 11184|
|Contact: Ayman Hammoudeh, MD, FACC 0096265001000 email@example.com|
|Contact: Walaa Abu Moghli, PharmD 0096265001000 firstname.lastname@example.org|
|The University of Jordan||Recruiting|
|Amman, Jordan, 11942|
|Contact: Hanna Makhamreh, MD +962 6 5355000 email@example.com|
|Ep Clinics Khalidi S||Recruiting|
|Contact: Munir Zaqqa, MD, FACC|
|Sub-Investigator: Ismail Hamam, MD|
|Integrated Center for Cardiovascular and Electric Diseases||Recruiting|
|Contact: Nazih Kadri, MD, FACC|
|Contact: Imad Alhaddad, MD 00962795303502 firstname.lastname@example.org|
|Khalidi Hospital & Medical Center||Recruiting|
|Contact: Ramzi Tabbalat, MD, FACC RAMZI_MD@YAHOO.COM|
|Contact: Mahmoud Izraiq Mahmoud Izraiq, MD|
|King Abdullah University Hospital||Recruiting|
|Contact: Mohamad Jarrah, MD|
|Study Chair:||Ayman Hammoudeh, MD, FACC||Cardiology Dept, Istishari Hospital, Amman, Jordan|