Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2025-12-24 @ 3:29 PM
Study NCT ID:
NCT03917992
Status:
COMPLETED
Last Update Posted:
2023-05-25
First Post:
2019-04-14
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Jordan Atrial Fibrillation Study: Baseline Risk Scores and One Year Outcome
Sponsor:
Ayman J Hammoudeh, MD, FACC
Organization:
Study Overview
Official Title:
The Baseline Features and CHA2DS2 VASc /HAS BLED Scores of Jordanian Patients With Atrial Fibrillation and the One Year Outcome
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: