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

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ClinicalTrials.gov Identifier: NCT03917992
Recruitment Status : Not yet recruiting
First Posted : April 17, 2019
Last Update Posted : April 23, 2019
Sponsor:
Information provided by (Responsible Party):
Ayman J. Hammoudeh, MD, FACC, Jordan Collaborating Cardiology Group

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.

Condition or disease
Atrial Fibrillation

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.


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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Baseline Features and CHA2DS2 VASc /HAS BLED Scores of Jordanian Patients With Atrial Fibrillation and the One Year Outcome
Estimated Study Start Date : May 15, 2019
Estimated Primary Completion Date : May 15, 2021
Estimated Study Completion Date : May 15, 2022

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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)

  2. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
All consecutive admissions aged 18+ years with new onset or known AF Admitted to participating hospitals
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

Information from the National Library of Medicine

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


Contacts
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Contact: Nazih Kadri, MD, FACC 00962796999695 d.kadri@hotmail.com
Contact: Ayman J Hammoudeh, MD, FACC 0096265001000 ext 220 a.hammoudeh@istisharihospital.com

Sponsors and Collaborators
Ayman J. Hammoudeh, MD, FACC

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Responsible Party: Ayman J. Hammoudeh, MD, FACC, The Jordanian Comprehensive Center For Electophysiologic Heart Disease, Jordan Collaborating Cardiology Group
ClinicalTrials.gov Identifier: NCT03917992     History of Changes
Other Study ID Numbers: JOAF1Y
First Posted: April 17, 2019    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We will make available to researchers the clinical from of the study and eventually the results and publications

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ayman J. Hammoudeh, MD, FACC, Jordan Collaborating Cardiology Group:
Atrial fibrillation

Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes