ClinicalTrials.gg
RecruitingNCT05213429MECAERUpdated May 4, 2025

Middle East Coronary Artery Ectasia Registry

An observational study in Coronary Artery Ectasia, sponsored by Interventional Cardiovascular Innovation Group, Jordan. Recruiting at 1 site in Jordan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-04.

Sponsored by Interventional Cardiovascular Innovation Group, Jordan · Observational

From the registry’s dates

  • Started Sep 2024; still recruiting 2 years 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
11,000
Ages
18 Years and older
Sex
All
01

Study 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 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 .
02

Conditions studied

  • Coronary Artery Ectasia

Browse trials for

03

In context

Coronary Aneurysm

31 studies on the registry are indexed under Coronary Aneurysm; 10 are open to participants now.

This study's planned enrollment of 11,000 is above the median of 100 across 13 observational studies indexed under Coronary Aneurysm.

Browse Coronary Aneurysm studies →

Lead sponsor

This is the only study on the registry with Interventional Cardiovascular Innovation Group, Jordan as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients with a coronary Ectasia diagnosis after PCI imaging

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subjects with suspected CAD who are referred for elective coronary angiography and fit the Coronary ectasia definition.

Exclusion criteria

Exclusion Criteria:

  • Patient younger than 18 years old.
  • Patients who refuse to sign a consent form . Patients who are enrolled in another Ectasia study
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
11,000 participants (estimated)
Patient registry
No

Interventions

  • Othernon interventional study

    non interventional

06

What researchers measure

Primary outcomes

  1. Cardiovascular events

    MI, stroke, angina and hospitalization

    Time frame: 1 year

Secondary outcomes

  1. all cause of death

    CV death , Non-CV death

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Sep 2024 (actual). Primary completion is estimated for Dec 2027, 39 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 4, 2022
First posted
Jan 28, 2022
StartActual
Sep 1, 2024
Primary completionEst.
Dec 31, 2027
CompletionEst.
Dec 31, 2027
Last update
May 4, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05213429
Lead sponsor
Interventional Cardiovascular Innovation Group, Jordan
Responsible party
Sponsor
First posted
Jan 28, 2022
Start date
Sep 1, 2024
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
May 4, 2025

Study contacts

Mahmoud I Izraiq, MD, FACC, FSCAI
Contact
izraiq@yahoo.com
00962795652260
Mahmoud I Izraiq, MD, FACC, FSCAI
study chair · Interventional Cardiovascular Innovation Group, Jordan

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion