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OpenTrials
Completed

NCT Number: NCT03896321

Coronary Artery Ectasia in Elective Coronary Angiography : Predictors, Outcomes and Management

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 remodelling (i.e. excessive expansive remodelling) 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 remodelling 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 ectatic segments, chronic anticoagulation with warfarin as main therapy was suggested

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Martina Gamil

Asyut, 23123, Egypt

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subjects with suspected CAD who are referred for elective coronary angiography

Exclusion criteria

  • Previous admission with an acute coronary event, previous PCI or CABG.
  • History of bleeding tendency or those with high bleeding risk according to the HAS-BLED bleeding risk score

Treatment and study plan

Antiplatelet Agents

Drug

effect of dual antiplatelet in management of coronary artery ectasia

Anticoagulants

Drug

effect of oral anticoagulants in management of coronary artery ectasia

Primary outcomes

  1. Efficacy of dual antiplatelet therapy vs oral anticoagulants in patients with CAE - occurance of major adverse cardiovascular events

    Time frame: 6 months

    Efficacy endpoints defined as the occurance of major adverse cardiovascular events (MACE)

  2. safety of dual antiplatelet therapy vs oral anticoagulants in patients with CAE - occurance of major or minor bleeding

    Time frame: 6 months

    safety endpoints of occurance of major or minor bleeding

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Mar 29, 2019
Registry last updated
Feb 13, 2024

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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