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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Assiut, Egypt, 23123
- Martina Gamil
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Asprin
Patient will receive dual anti platelet asprin And clopidogrel
|
effect of dual antiplatelet in management of coronary artery ectasia
|
|
Active Comparator: Clopidogrel
Patient will receive dual anti platelet asprin And clopidogrel
|
effect of dual antiplatelet in management of coronary artery ectasia
|
|
Active Comparator: Warfarin
Patient will receive oral anticoagulation
|
effect of oral anticoagulants in management of coronary artery ectasia
|
|
Active Comparator: Novel oral anticoagulant
Patient will receive oral anticoagulation
|
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
Time Frame: 6 months
|
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
Time Frame: 6 months
|
safety endpoints of occurance of major or minor bleeding
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Salwa R. Demitry, Professor, Assiut University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Coronary Artery Ectasia
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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