| Condition or disease |
|---|
| Atrial Fibrillation |
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
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 |
| 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 |
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
| Contact: Nazih Kadri, MD, FACC | 00962796999695 | d.kadri@hotmail.com | |
| Contact: Ayman J Hammoudeh, MD, FACC | 0096265001000 ext 220 | a.hammoudeh@istisharihospital.com |
| 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 | |
| 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 |
|
||||||||
| Original Primary Outcome Measures |
|
||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures | Not Provided | ||||||||
| Original Secondary Outcome Measures |
|
||||||||
| 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
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 |
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:
Exclusion Criteria:
|
||||||||
| Sex/Gender |
|
||||||||
| Ages | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | Not Provided | ||||||||
| Contacts |
|
||||||||
| 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 |
|
||||||||
| IPD Sharing Statement |
|
||||||||
| Responsible Party | Ayman J. Hammoudeh, MD, FACC, Jordan Collaborating Cardiology Group | ||||||||
| Study Sponsor | Ayman J. Hammoudeh, MD, FACC | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators |
|
||||||||
| PRS Account | Jordan Collaborating Cardiology Group | ||||||||
| Verification Date | April 2019 | ||||||||