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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03896321
• Other study ID #: Coronary Artery Ectasia
• Status: Completed
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: February 1, 2022

Study information

• Verified date: February 2024
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: February 1, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Aneurysm
• Coronary Artery Disease
• Ectasia

Intervention

Drug:
• Antiplatelet Agents
effect of dual antiplatelet in management of coronary artery ectasia
• Anticoagulants
effect of oral anticoagulants in management of coronary artery ectasia

Locations

Country	Name	City	State
Egypt	Martina Gamil	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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