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

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Ectasia
• Intervention / Treatment: Drug: Antiplatelet Agents; Drug: Anticoagulants

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 23123
    • Martina Gamil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Asprin; Patient will receive dual anti platelet asprin And clopidogrel	Drug: Antiplatelet Agents; effect of dual antiplatelet in management of coronary artery ectasia
Active Comparator: Clopidogrel; Patient will receive dual anti platelet asprin And clopidogrel	Drug: Antiplatelet Agents; effect of dual antiplatelet in management of coronary artery ectasia
Active Comparator: Warfarin; Patient will receive oral anticoagulation	Drug: Anticoagulants; effect of oral anticoagulants in management of coronary artery ectasia
Active Comparator: Novel oral anticoagulant; Patient will receive oral anticoagulation	Drug: Anticoagulants; effect of oral anticoagulants in management of coronary artery ectasia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of dual antiplatelet therapy vs oral anticoagulants in patients with CAE - occurance of major adverse cardiovascular events	Efficacy endpoints defined as the occurance of major adverse cardiovascular events (MACE)	6 months
safety of dual antiplatelet therapy vs oral anticoagulants in patients with CAE - occurance of major or minor bleeding	safety endpoints of occurance of major or minor bleeding	6 months

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: Salwa R. Demitry, Professor, Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): February 1, 2022

Study Registration Dates

• First Submitted: March 23, 2019
• First Submitted That Met QC Criteria: March 28, 2019
• First Posted (Actual): March 29, 2019

Study Record Updates

• Last Update Posted (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 10, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pathological Conditions, Anatomical; Coronary Disease; Aneurysm; Coronary Artery Disease; Dilatation, Pathologic; Coronary Aneurysm; Anticoagulants; Platelet Aggregation Inhibitors
• Other Study ID Numbers: Coronary Artery Ectasia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No