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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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.

Mahmoud I Izraiq, MD, FACC, FSCAI contact

00962795652260

izraiq@yahoo.com

Jordan1 site, 1 recruiting
  • Specialty Hospital

    Amman

    Mahmood Izraiq

    Recruiting

Other trials in Jordan

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 .
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.

  1. Cardiovascular events

    MI, stroke, angina and hospitalization

    Measured: 1 year

Secondary outcomes (1)
  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.

  1. First posted28 Jan 2022
  2. Study start1 Sep 2024
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

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)
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 27142049
  • Hartnell 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 4052280
  • Willner 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

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.

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