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出境医 / 临床实验 / The Jordan Atrial Fibrillation Study: Baseline Risk Scores and One Year Outcome

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

Study Description
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.

Study Design
Layout table for study information
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
Actual Study Start Date : May 25, 2019
Estimated Primary Completion Date : May 25, 2021
Estimated Study Completion Date : May 15, 2022
Arms and Interventions
Outcome Measures
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).


Eligibility Criteria
Layout table for eligibility information
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
Contacts and Locations

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

Locations
Layout table for location information
Jordan
Istishari Hospital Recruiting
Amman, Jordan, 11184
Contact: Ayman Hammoudeh, MD, FACC    0096265001000    a.hammoudeh@istisharihospital.com   
Contact: Walaa Abu Moghli, PharmD    0096265001000    a.hammoudeh@istisharihospital.com   
The University of Jordan Recruiting
Amman, Jordan, 11942
Contact: Hanna Makhamreh, MD    +962 6 5355000    osobaidat@yahoo.com   
Ep Clinics Khalidi S Recruiting
Amman, Jordan
Contact: Munir Zaqqa, MD, FACC         
Sub-Investigator: Ismail Hamam, MD         
Integrated Center for Cardiovascular and Electric Diseases Recruiting
Amman, Jordan
Contact: Nazih Kadri, MD, FACC         
Jordan Hospital Recruiting
Amman, Jordan
Contact: Imad Alhaddad, MD    00962795303502    alhaddad63@gmail.com   
Khalidi Hospital & Medical Center Recruiting
Amman, Jordan
Contact: Ramzi Tabbalat, MD, FACC       RAMZI_MD@YAHOO.COM   
Specialty Hospital Recruiting
Amman, Jordan
Contact: Mahmoud Izraiq Mahmoud Izraiq, MD         
King Abdullah University Hospital Recruiting
Irbid, Jordan
Contact: Mohamad Jarrah, MD         
Sponsors and Collaborators
Ayman J. Hammoudeh, MD, FACC
Investigators
Layout table for investigator information
Study Chair: Ayman Hammoudeh, MD, FACC Cardiology Dept, Istishari Hospital, Amman, Jordan
Tracking Information
First Submitted Date April 14, 2019
First Posted Date April 17, 2019
Last Update Posted Date June 25, 2019
Actual Study Start Date May 25, 2019
Estimated Primary Completion Date May 25, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 20, 2019)
  • 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).
Original Primary Outcome Measures
 (submitted: April 14, 2019)
  • Stroke and systemic embolization at one year [ Time Frame: one year ]
    Composite number of patients who at 1 year develop thrombo-embolic or hemorrhagic stroke/TIA/systemic embolization
  • Major bleeding events at one year [ Time Frame: one year ]
    Major bleeding events as defined by the HAS BLED score investigators at one year
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures
 (submitted: April 14, 2019)
  • Relation between CHADS2 VA2Sc score and thromboembolic events [ Time Frame: one year ]
    Composite number of patients who at 1 year develop thrombo-embolic or hemorrhagic stroke/TIA/systemic embolization in relation to the score of 1 or less, 2, 3 or more
  • Major bleeding events at one year [ Time Frame: one year ]
    Major bleeding events as defined by the HAS BLED score investigators at one year in relation to the HAS BLED score
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Jordan Atrial Fibrillation Study: Baseline Risk Scores and One Year Outcome
Official Title The Baseline Features and CHA2DS2 VASc /HAS BLED Scores of Jordanian Patients With Atrial Fibrillation and the One Year Outcome
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All consecutive admissions aged 18+ years with new onset or known AF Admitted to participating hospitals
Condition Atrial Fibrillation
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Hammoudeh AJ, Khader Y, Kadri N, Al-Mousa E, Badaineh Y, Habahbeh L, Tabbalat R, Janabi H, Alhaddad IA. Adherence to the 2019 AHA/ACC/HRS Focused Update of the 2014 AHA/ACC/HRS Guideline on the Use of Oral Anticoagulant Agents in Middle Eastern Patients with Atrial Fibrillation: The Jordan Atrial Fibrillation (JoFib) Study. Int J Vasc Med. 2021 Apr 8;2021:5515089. doi: 10.1155/2021/5515089. eCollection 2021.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 14, 2019)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 15, 2022
Estimated Primary Completion Date May 25, 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Nazih Kadri, MD, FACC 00962796999695 d.kadri@hotmail.com
Contact: Ayman J Hammoudeh, MD, FACC 0096265001000 ext 220 a.hammoudeh@istisharihospital.com
Listed Location Countries Jordan
Removed Location Countries  
 
Administrative Information
NCT Number NCT03917992
Other Study ID Numbers JOAF1Y
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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
Responsible Party Ayman J. Hammoudeh, MD, FACC, Jordan Collaborating Cardiology Group
Study Sponsor Ayman J. Hammoudeh, MD, FACC
Collaborators Not Provided
Investigators
Study Chair: Ayman Hammoudeh, MD, FACC Cardiology Dept, Istishari Hospital, Amman, Jordan
PRS Account Jordan Collaborating Cardiology Group
Verification Date April 2019