Coronary Artery EctasiaMECAERNCT05213429
Middle East Coronary Artery Ectasia Registry
An observational study of Coronary Artery Ectasia, run by Jordanian Research and Artificial Intelligence Group at 1 site in Jordan.
Trial summary
This research project is the first in Jordan and Middle East in providing detailed registration of coronary ectasia cases provided by their primary healthcare providers. The investigators responsible for conducting this research are physicians and their teams who deal with patients with coronary ectasia in their… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Ectasia
- What is being tested?
- non interventional study
- How many people
- 11,000 participants
- Where
- 1 siteJordan
- Study dates
- 1 Sep 2024to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: All patients with a coronary Ectasia diagnosis after PCI imaging
Who may be able to join
- Subjects with suspected CAD who are referred for elective coronary angiography and fit the Coronary ectasia definition.
Who cannot join
- Patient younger than 18 years old.
- Patients who refuse to sign a consent form . Patients who are enrolled in another Ectasia study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Middle East Coronary Artery Ectasia Registry (MECAER): Incidence, Management, and One-Year Prognosis: A Multi-Centre Prospective Cohort Study.
This research project is the first in Jordan and Middle East in providing detailed registration of coronary ectasia cases provided by their primary healthcare providers. The investigators responsible for conducting this research are physicians and their teams who deal with patients with coronary ectasia in their clinics including the public and private medical sectors.
Read the detailed description
Coronary artery ectasia (CAE) is the diffuse dilatation of coronary artery. It is defined as a dilatation with a diameter of 1.5 times the adjacent normal coronary artery. Its prevalence ranges from 1.2%-4.9% with male to female ratio of 3:1 .
Coronary ectasia likely represents an exaggerated form of expansive vascular remodeling (i.e. excessive expansive remodeling) in response to atherosclerotic plaque growth .
CAE is more common in males. Hypertension is a risk Factor. Interestingly, patients with DM have low incidence of CAE. This may be due to down regulation of MMP with negative remodeling in response to atherosclerosis . Smoking appears to be more common in patients with CAE than in those with coronary artery disease (CAD).
The angiographic classification for CAE (described by Markis et al.) categorizes the severity based on the extent of coronary arterial involvement: Type 1: Diffuse ectasia of 2-3 arteries; Type 2: Diffuse ectasia in one artery and localized in another; Type 3: Diffuse single arterial ectasia; Type 4: Localized or segmental ectasia.
Stable angina is the most common presentation in patients with CAE . Patients with CAE without stenosis had positive results during treadmill exercise tests. ST-elevation myocardial infarction (MI) , non-ST elevation MI can occur from altered blood flow by distal embolization or occlusion of ectatic segment with thrombus.
Medical management for CAE is a controversial area as there is lack of evidence based medicine, especially the role of antiplatelet versus anticoagulant agents. Aspirin was suggested in all patients because of coexistence of CAE with obstructive coronary lesions in the great majority of patients and the observed incidence of myocardial infarction, even in patients with isolated coronary ectasia .The role of dual anti platelet therapy has not been evaluated in prospective randomized studies. Based on the significant flow disturbances within the ecstatic segments, chronic anticoagulation with warfarin as main therapy was suggested
this study aims to fill the existing gap in the cardiac community about the topic of coronary ectasia. There is a substantial lack of dependable scientific data regarding the prevalence and disease prognosis of coronary ectasia. Screening, management and follow-up of coronary ectasia patients combined with comparative tests with reference studies will be initiated. A direct impact on improving coronary ectasia prognostic outcomes is expected by focusing efforts on determining the prevalence, prognosis and management procedures of ectasia. collected data will aid in improving the current therapeutic approaches to coronary ectasia and providing better control and management of coronary ectasia cases in the Middle East.
Study objectives:
Taking into account the classical coronary ectasia definition, the investigators propose:
- ANATOMIC OBJECTIVES.
- To characterize coronary ectasia prevalence causing invasive coronary angiography.
- To describe anatomy, location and aneurysms features.
- To assess intracoronary imaging data if available.
- To determine the underlying causes of coronary ectasia in patients
- CLINICAL OBJECTIVES.
- Determine the cause for the diagnostic catheterization and ectasia symptoms, if present.
- Patient´s clinical features.
- Long-term outcomes.
- THERAPEUTIC OBJECTIVES.
- To assess management strategies (conservative, interventional or surgical) and its short and long term results.
- Disease management outcomes .
- Conditions
- Coronary Artery Ectasia
- Being tested
- non interventional study
- Medical subject headings
- Coronary Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non interventional studyOther
non interventional
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular events
MI, stroke, angina and hospitalization
Measured: 1 year
Secondary outcomes (1)
all cause of death
CV death , Non-CV death
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 posted28 Jan 2022
- Study start1 Sep 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery EctasiaStudies 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
- 11,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jordanian Research and Artificial Intelligence Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mahmoud I Izraiq, MD, FACC, FSCAI, Study chair, Jordanian Research and Artificial Intelligence Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05213429
- Sponsor's protocol ID
- JoRAI group
- Acronym
- MECAER
- Status last verified
- May 2025
- First submitted
- 4 Jan 2022
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Devabhaktuni S, Mercedes A, Diep J, Ahsan C. Coronary Artery Ectasia-A Review of Current Literature. Curr Cardiol Rev. 2016;12(4):318-323. doi: 10.2174/1573403x12666160504100159.
PubMed 27142049Hartnell GG, Parnell BM, Pridie RB. Coronary artery ectasia. Its prevalence and clinical significance in 4993 patients. Br Heart J. 1985 Oct;54(4):392-5. doi: 10.1136/hrt.54.4.392.
PubMed 4052280Willner NA, Ehrenberg S, Musallam A, Roguin A. Coronary artery ectasia: prevalence, angiographic characteristics and clinical outcome. Open Heart. 2020 Apr;7(1):e001096. doi: 10.1136/openhrt-2019-001096.
PubMed 32515749
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Middle East Coronary Artery Ectasia Registry (MECAER): Incidence, Management, and One-Year Prognosis: A Multi-Centre Prospective Cohort Study.
- ClinicalTrials.gov ID
- NCT05213429
- Acronym / sponsor ID
- MECAER / JoRAI group
- Conditions
- Coronary Artery Ectasia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 11,000 participants (estimated)
- Lead sponsor
- Jordanian Research and Artificial Intelligence GroupUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 28 Jan 2022 (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.
This research project is the first in Jordan and Middle East in providing detailed registration of coronary ectasia cases provided by their primary healthcare providers. The investigators responsible for conducting this research are physicians and their teams who deal with patients with coronary ectasia in their clinics including the public and private medical sectors.
Detailed description
Coronary artery ectasia (CAE) is the diffuse dilatation of coronary artery. It is defined as a dilatation with a diameter of 1.5 times the adjacent normal coronary artery. Its prevalence ranges from 1.2%-4.9% with male to female ratio of 3:1 .
Coronary ectasia likely represents an exaggerated form of expansive vascular remodeling (i.e. excessive expansive remodeling) in response to atherosclerotic plaque growth .
CAE is more common in males. Hypertension is a risk Factor. Interestingly, patients with DM have low incidence of CAE. This may be due to down regulation of MMP with negative remodeling in response to atherosclerosis . Smoking appears to be more common in patients with CAE than in those with coronary artery disease (CAD).
The angiographic classification for CAE (described by Markis et al.) categorizes the severity based on the extent of coronary arterial involvement: Type 1: Diffuse ectasia of 2-3 arteries; Type 2: Diffuse ectasia in one artery and localized in another; Type 3: Diffuse single arterial ectasia; Type 4: Localized or segmental ectasia.
Stable angina is the most common presentation in patients with CAE . Patients with CAE without stenosis had positive results during treadmill exercise tests. ST-elevation myocardial infarction (MI) , non-ST elevation MI can occur from altered blood flow by distal embolization or occlusion of ectatic segment with thrombus.
Medical management for CAE is a controversial area as there is lack of evidence based medicine, especially the role of antiplatelet versus anticoagulant agents. Aspirin was suggested in all patients because of coexistence of CAE with obstructive coronary lesions in the great majority of patients and the observed incidence of myocardial infarction, even in patients with isolated coronary ectasia .The role of dual anti platelet therapy has not been evaluated in prospective randomized studies. Based on the significant flow disturbances within the ecstatic segments, chronic anticoagulation with warfarin as main therapy was suggested
this study aims to fill the existing gap in the cardiac community about the topic of coronary ectasia. There is a substantial lack of dependable scientific data regarding the prevalence and disease prognosis of coronary ectasia. Screening, management and follow-up of coronary ectasia patients combined with comparative tests with reference studies will be initiated. A direct impact on improving coronary ectasia prognostic outcomes is expected by focusing efforts on determining the prevalence, prognosis and management procedures of ectasia. collected data will aid in improving the current therapeutic approaches to coronary ectasia and providing better control and management of coronary ectasia cases in the Middle East.
Study objectives:
Taking into account the classical coronary ectasia definition, the investigators propose:
- ANATOMIC OBJECTIVES.
- To characterize coronary ectasia prevalence causing invasive coronary angiography.
- To describe anatomy, location and aneurysms features.
- To assess intracoronary imaging data if available.
- To determine the underlying causes of coronary ectasia in patients
- CLINICAL OBJECTIVES.
- Determine the cause for the diagnostic catheterization and ectasia symptoms, if present.
- Patient´s clinical features.
- Long-term outcomes.
- THERAPEUTIC OBJECTIVES.
- To assess management strategies (conservative, interventional or surgical) and its short and long term results.
- Disease management outcomes .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with a coronary Ectasia diagnosis after PCI imaging
Key inclusion criteria (1 listed)
- Subjects with suspected CAD who are referred for elective coronary angiography and fit the Coronary ectasia definition.
Key exclusion criteria (2 listed)
- Patient younger than 18 years old.
- Patients who refuse to sign a consent form . Patients who are enrolled in another Ectasia study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non interventional studynon interventional | Other | – |
Primary outcome
Cardiovascular events
Time frame: 1 year
MI, stroke, angina and hospitalization
1 secondary outcome
all cause of death
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- Background: PubMed 27142049Devabhaktuni S, Mercedes A, Diep J, Ahsan C. Coronary Artery Ectasia-A Review of Current Literature. Curr Cardiol Rev. 2016;12(4):318-323. doi: 10.2174/1573403x12666160504100159.
- Background: PubMed 4052280Hartnell GG, Parnell BM, Pridie RB. Coronary artery ectasia. Its prevalence and clinical significance in 4993 patients. Br Heart J. 1985 Oct;54(4):392-5. doi: 10.1136/hrt.54.4.392.
- Background: PubMed 32515749Willner NA, Ehrenberg S, Musallam A, Roguin A. Coronary artery ectasia: prevalence, angiographic characteristics and clinical outcome. Open Heart. 2020 Apr;7(1):e001096. doi: 10.1136/openhrt-2019-001096.
- 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.
Mahmoud I Izraiq, MD, FACC, FSCAI study chair
Jordanian Research and Artificial Intelligence Group
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 Coronary Artery Ectasia, run by Jordanian Research and Artificial Intelligence 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 1 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: looking for participants now, as of the sponsor's last update on 4 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud I Izraiq, MD, FACC, FSCAI (00962795652260, izraiq@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular events (time frame: 1 year). 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 NCT05213429, which also lists 3 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 4 May 2025.