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

May 24, 2023 updated by: Ayman J Hammoudeh, MD, FACC

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

2020

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Jordan
      • Amman, Jordan, 11184
        • Istishari Hospital
      • Amman, Jordan, 11942
        • The University of Jordan
      • Amman, Jordan
        • Jordan Hospital
      • Amman, Jordan
        • Specialty Hospital
      • Amman, Jordan
        • Khalidi Hospital & Medical Center
      • Amman, Jordan
        • Ep Clinics Khalidi S
      • Amman, Jordan
        • Integrated Center for Cardiovascular and Electric Diseases
      • Irbid, Jordan
        • King Abdullah University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

All consecutive admissions aged 18+ years with new onset or known AF Admitted to participating hospitals

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
one year
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).
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ayman J Hammoudeh, MD, FACC

Investigators

  • Study Chair: Ayman Hammoudeh, MD, FACC, Cardiology Dept, Istishari Hospital, Amman, Jordan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 25, 2019

Primary Completion (Actual)

November 25, 2021

Study Completion (Actual)

November 25, 2021

Study Registration Dates

First Submitted

April 14, 2019

First Submitted That Met QC Criteria

April 14, 2019

First Posted (Actual)

April 17, 2019

Study Record Updates

Last Update Posted (Actual)

May 25, 2023

Last Update Submitted That Met QC Criteria

May 24, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JOAF1Y

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

We will make available to researchers the clinical from of the study and eventually the results and publications

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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