Atrial FibrillationNCT03917992
The Jordan Atrial Fibrillation Study: Baseline Risk Scores and One Year Outcome
An observational study of Atrial Fibrillation, run by Ayman J Hammoudeh, MD, FACC at 8 sites in Jordan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 2,020 participants
- Where
- 8 sitesJordan
- Study dates
- 25 May 2019to 25 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: All consecutive admissions aged 18+ years with new onset or known AF Admitted to participating hospitals
Who may be able to join
- Age 18 years or above
- Admission with atrial fibrillation or clinic visit for atrial fibrillation
- Signing the consent form
Who cannot join
- Age less than 18 years
- Refusal of signing the censent form
- Grave systemic disease with high probability of in hospital death
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Jordan8 sites
Istishari Hospital
Amman, 11184
The University of Jordan
Amman, 11942
Ep Clinics Khalidi S
Amman
Integrated Center for Cardiovascular and Electric Diseases
Amman
Jordan Hospital
Amman
Khalidi Hospital & Medical Center
Amman
Specialty Hospital
Amman
King Abdullah University Hospital
Irbid
About this study
Official title: 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.
Read the 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
- 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.
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke and systemic embolization at 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)
Measured: one year
Major bleeding events at 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).
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2019
- Study start25 May 2019
- Primary completion25 Nov 2021
- Study completion25 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,020 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ayman J Hammoudeh, MD, FACC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ayman J Hammoudeh, MD, FACC, Jordan Collaborating Cardiology Group
- Investigators
- Ayman Hammoudeh, MD, FACC, Study chair, Cardiology Dept, Istishari Hospital, Amman, Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03917992
- Sponsor's protocol ID
- JOAF1Y
- Status last verified
- May 2023
- First submitted
- 14 Apr 2019
- Last updated
- 25 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We will make available to researchers the clinical from of the study and eventually the results and publications
Publications
Al-Kasasbeh A, Alghzawi AA, Alfakhouri A, Kadri N, Aloqaily A, Al-Oakily M, Awad B, Hammoudeh AJ. Clinical Profiles of Hospitalized Middle Eastern Patients With Nonvalvular Atrial Fibrillation: Analysis From the JoFib Study. Int J Vasc Med. 2026 Aug 7;2026:6426995. doi: 10.1155/ijvm/6426995. eCollection 2026.
PubMed 42571272Abdin B, Abuqweider E, Alhaddad I, Shabaneh R, Bader G, Bader T, Abu-Shaban M, Salah Q, Hammoudeh A. The Effect of Multimorbidity and Anticoagulation Use in Patients with Atrial Fibrillation on The One-Year Outcome: Analysis from Jordan Atrial Fibrillation (JoFIB) Study - A Prospective Cohort Study. BMJ Open. 2025 Dec 28;15(12):e102661. doi: 10.1136/bmjopen-2025-102661.
PubMed 41461398Hammoudeh A, Badaineh Y, Tabbalat R, Ahmad A, Bahhour M, Ja'ara D, Shehadeh J, Jum'ah MA, Migdad A, Hani M, Alhaddad IA. The Intersection of Atrial Fibrillation and Coronary Artery Disease in Middle Eastern Patients. Analysis from the Jordan Atrial Fibrillation Study. Glob Heart. 2024 Mar 12;19(1):29. doi: 10.5334/gh.1312. eCollection 2024.
PubMed 38505303Alrabadi N, Al-Nusair M, Haddad R, Alburie L, Mhaidat N, Aljarrah M, Hamoudeh A. Cardiovascular medications used for comorbid diseases in patients with atrial fibrillation. The JoFib study. Eur J Clin Pharmacol. 2024 Apr;80(4):545-552. doi: 10.1007/s00228-024-03622-8. Epub 2024 Jan 23.
PubMed 38253701Al-Makhamreh H, Alrabadi N, Haikal L, Krishan M, Al-Badaineh N, Odeh O, Barqawi T, Nawaiseh M, Shaban A, Abdin B, Khamies L, Hammoudeh A. Paroxysmal and Non-Paroxysmal Atrial Fibrillation in Middle Eastern Patients: Clinical Features and the Use of Medications. Analysis of the Jordan Atrial Fibrillation (JoFib) Study. Int J Environ Res Public Health. 2022 May 19;19(10):6173. doi: 10.3390/ijerph19106173.
PubMed 35627709Alhaddad Z, Hammoudeh A, Khader Y, Alhaddad IA. Demographics and Risk Profile of Elderly Middle Eastern Patients with Atrial Fibrillation: The Jordan Atrial Fibrillation (JoFib) Study. Vasc Health Risk Manag. 2022 Apr 15;18:289-295. doi: 10.2147/VHRM.S360822. eCollection 2022.
PubMed 35449533Hammoudeh 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.
PubMed 33898065
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Baseline Features and CHA2DS2 VASc /HAS BLED Scores of Jordanian Patients With Atrial Fibrillation and the One Year Outcome
- ClinicalTrials.gov ID
- NCT03917992
- Acronym / sponsor ID
- JOAF1Y
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,020 participants (actual)
- Lead sponsor
- Ayman J Hammoudeh, MD, FACCUniversity, hospital or other
- Study start
- 25 May 2019 (actual)
- Primary completion
- 25 Nov 2021 (actual)
- Study completion
- 25 Nov 2021 (actual)
- First posted
- 17 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All consecutive admissions aged 18+ years with new onset or known AF Admitted to participating hospitals
Key inclusion criteria (3 listed)
- Age 18 years or above
- Admission with atrial fibrillation or clinic visit for atrial fibrillation
- Signing the consent form
Key exclusion criteria (3 listed)
- Age less than 18 years
- Refusal of signing the censent form
- Grave systemic disease with high probability of in hospital death
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
- Derived from this study: PubMed 42571272Al-Kasasbeh A, Alghzawi AA, Alfakhouri A, Kadri N, Aloqaily A, Al-Oakily M, Awad B, Hammoudeh AJ. Clinical Profiles of Hospitalized Middle Eastern Patients With Nonvalvular Atrial Fibrillation: Analysis From the JoFib Study. Int J Vasc Med. 2026 Aug 7;2026:6426995. doi: 10.1155/ijvm/6426995. eCollection 2026.
- Derived from this study: PubMed 41461398Abdin B, Abuqweider E, Alhaddad I, Shabaneh R, Bader G, Bader T, Abu-Shaban M, Salah Q, Hammoudeh A. The Effect of Multimorbidity and Anticoagulation Use in Patients with Atrial Fibrillation on The One-Year Outcome: Analysis from Jordan Atrial Fibrillation (JoFIB) Study - A Prospective Cohort Study. BMJ Open. 2025 Dec 28;15(12):e102661. doi: 10.1136/bmjopen-2025-102661.
- Derived from this study: PubMed 38505303Hammoudeh A, Badaineh Y, Tabbalat R, Ahmad A, Bahhour M, Ja'ara D, Shehadeh J, Jum'ah MA, Migdad A, Hani M, Alhaddad IA. The Intersection of Atrial Fibrillation and Coronary Artery Disease in Middle Eastern Patients. Analysis from the Jordan Atrial Fibrillation Study. Glob Heart. 2024 Mar 12;19(1):29. doi: 10.5334/gh.1312. eCollection 2024.
- Derived from this study: PubMed 38253701Alrabadi N, Al-Nusair M, Haddad R, Alburie L, Mhaidat N, Aljarrah M, Hamoudeh A. Cardiovascular medications used for comorbid diseases in patients with atrial fibrillation. The JoFib study. Eur J Clin Pharmacol. 2024 Apr;80(4):545-552. doi: 10.1007/s00228-024-03622-8. Epub 2024 Jan 23.
- Derived from this study: PubMed 35627709Al-Makhamreh H, Alrabadi N, Haikal L, Krishan M, Al-Badaineh N, Odeh O, Barqawi T, Nawaiseh M, Shaban A, Abdin B, Khamies L, Hammoudeh A. Paroxysmal and Non-Paroxysmal Atrial Fibrillation in Middle Eastern Patients: Clinical Features and the Use of Medications. Analysis of the Jordan Atrial Fibrillation (JoFib) Study. Int J Environ Res Public Health. 2022 May 19;19(10):6173. doi: 10.3390/ijerph19106173.
- Derived from this study: PubMed 35449533Alhaddad Z, Hammoudeh A, Khader Y, Alhaddad IA. Demographics and Risk Profile of Elderly Middle Eastern Patients with Atrial Fibrillation: The Jordan Atrial Fibrillation (JoFib) Study. Vasc Health Risk Manag. 2022 Apr 15;18:289-295. doi: 10.2147/VHRM.S360822. eCollection 2022.
- Derived from this study: PubMed 33898065Hammoudeh 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.
- Individual participant dataSharing planned: Undecided. We will make available to researchers the clinical from of the study and eventually the results and publications
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayman Hammoudeh, MD, FACC study chair
Cardiology Dept, Istishari Hospital, Amman, Jordan
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Ayman J Hammoudeh, MD, FACC at 8 sites in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroke and systemic embolization at one year (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03917992, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2023.