Atrial FibrillationJoAFRNCT02680483
Atrial Fibrillation Registry in Jordan
An observational study of Atrial Fibrillation, run by Jordan Collaborating Cardiology Group at 1 site in Jordan.
Trial summary
Prospective registry of all new comers with Atrial fibrillation Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 2,000 participants
- Where
- 1 siteJordan
- Study dates
- Aug 2016to Mar 2018
- How long will I take part?
- 1 Year
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All new admissions with atrial fibrillation above the age of 18 or those who develop atrial fibrillation during hospitalization for non AF reason.
Who may be able to join
- Admission with atrial fibrillation
- developing atrial fibrillation during hospitalization for mon AF reason.
- age 18 or more years.
- patients welling to participate in the registry.
Who cannot join
- age less than 18 years.
- patients not welling to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Prospective registry of all new comers with Atrial fibrillation
Read the detailed description
12 tertiary care centers will enroll all AF comers. Details of baseline clinical, EKG, echo, and lab data will be documented for all patients. Management is according to the physicians discretion. Patients will be followed up for 1 year for clinical endpoints including cardiovascular death, stroke, heart failure, systemic embolization and bleeding.. Anticoagulants and other cardiovascular medications will also be documented.
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, Registry, Middle East, Jordan, risk factors, in hospital management, long term management
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| AF cohort | AF consecutive patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of stroke and systemic embolization and cardiovascular death
all ischemic and hemorrhagic strokes and embolization to any arterial bed during follow up period
Measured: 1 year
Secondary outcomes (2)
Number of readmission for atrial fibrillation
readmission for atrial fibrillation related problem other than primary such as palpitations, hypotension, syncope, or near syncope.
Measured: 1 year
Number of readmission for other cardiovascular events
Atrial Fibrillation in Jordan: risk factors, presentations, in hospital management, long term management, clinical events in hospital and at one year
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2016 (estimated)
- Study startAug 2016
- Primary completionAug 2017
- Study completionMar 2018
Why it stopped: No interested parties agreed to enroll. Poor enrolling rate. In March 2018, the study was terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Jordan Collaborating Cardiology Group
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman J Hammoudeh, MD, FACC, Jordan Collaborating Cardiology Group
- Investigators
- Munir Zaqqa, MD FACC, Study director, Istishari Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02680483
- Sponsor's protocol ID
- JoAFR-JCCG
- Acronym
- JoAFR
- Status last verified
- May 2023
- First submitted
- 8 Feb 2016
- Last updated
- 25 May 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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
- Atrial Fibrillation Registry in Jordan
- ClinicalTrials.gov ID
- NCT02680483
- Acronym / sponsor ID
- JoAFR / JoAFR-JCCG
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, Registry, Middle East, Jordan, risk factors, in hospital management, long term management
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: No interested parties agreed to enroll. Poor enrolling rate. In March 2018, the study was terminated.
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Jordan Collaborating Cardiology GroupUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Aug 2017 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 11 Feb 2016 (estimated)
- 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.
Prospective registry of all new comers with Atrial fibrillation
Detailed description
12 tertiary care centers will enroll all AF comers. Details of baseline clinical, EKG, echo, and lab data will be documented for all patients. Management is according to the physicians discretion. Patients will be followed up for 1 year for clinical endpoints including cardiovascular death, stroke, heart failure, systemic embolization and bleeding.. Anticoagulants and other cardiovascular medications will also be documented.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AF cohort | – | –AF consecutive patients |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All new admissions with atrial fibrillation above the age of 18 or those who develop atrial fibrillation during hospitalization for non AF reason.
Key inclusion criteria (4 listed)
- Admission with atrial fibrillation
- developing atrial fibrillation during hospitalization for mon AF reason.
- age 18 or more years.
- patients welling to participate in the registry.
Key exclusion criteria (2 listed)
- age less than 18 years.
- patients not welling to participate.
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
Incidence of stroke and systemic embolization and cardiovascular death
Time frame: 1 year
all ischemic and hemorrhagic strokes and embolization to any arterial bed during follow up period
2 secondary outcomes
Number of readmission for atrial fibrillation
Time frame: 1 year
Number of readmission for other cardiovascular events
Time frame: 1 year
Results and safety
The study was stopped early (reason given: No interested parties agreed to enroll. Poor enrolling rate. In March 2018, the study was terminated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
- Individual participant dataSharing planned: No
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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.
Munir Zaqqa, MD FACC study director
Istishari Hospital
1 site 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 Jordan Collaborating Cardiology Group at 1 site 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 4 inclusion and 2 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: stopped early, 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 1 site 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 was stopped early (reason given: No interested parties agreed to enroll. Poor enrolling rate. In March 2018, the study was terminated.). Results are not available in the source record.
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?
Incidence of stroke and systemic embolization and cardiovascular death (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.