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

Not Applicable

Completed

• Conditions: Coronary Artery Disease; Ectasia
• Interventions: Drug: Anticoagulants; Drug: Antiplatelet Agents

• Registration Number: NCT03896321
• Lead Sponsor: Assiut University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-23
• Study First Submitted QC: 2019-03-28
• Study First Posted: 2019-03-29
• Study Start: 2019-12-01
• Primary Completion: 2021-12-01
• Study Completion: 2022-02-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-10
• Last Update Posted: 2024-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Novel oral anticoagulant	Anticoagulants	Patient will receive oral anticoagulation
Asprin	Antiplatelet Agents	Patient will receive dual anti platelet asprin And clopidogrel
Clopidogrel	Antiplatelet Agents	Patient will receive dual anti platelet asprin And clopidogrel
Warfarin	Anticoagulants	Patient will receive oral anticoagulation

Primary Outcome Measures

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

Trial Locations

Locations (1)

Martina Gamil; 🇪🇬 Assiut, Egypt