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NCT Number: NCT05213429

Middle East Coronary Artery Ectasia Registry

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Specialty Hospital

Amman, Jordan

Location status: Recruiting

Location contact

Mahmood Izraiq

CONTACT

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Non interventional study

Other

non interventional

Primary outcomes

  1. Cardiovascular events

    Time frame: 1 year

    MI, stroke, angina and hospitalization

Secondary outcomes

  1. all cause of death

    Time frame: 1 year

    CV death , Non-CV death

Study contacts

Contact information is provided by the study sponsor or research team.

Mahmoud I Izraiq, MD, FACC, FSCAI

CONTACT

[email protected]

00962795652260

Sponsors and collaborators

Lead sponsor

Jordanian Research and Artificial Intelligence Group

Other

Registry information

Official study title

Middle East Coronary Artery Ectasia Registry (MECAER): Incidence, Management, and One-Year Prognosis: A Multi-Centre Prospective Cohort Study.

Acronym: MECAER

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jan 28, 2022
Registry last updated
May 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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