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

NCT03896321 | Completed

• 1 other identifier: Coronary Artery Ectasia
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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

Conditions

Ectasia; Coronary Artery Disease

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (4)

Asprin

ACTIVE COMPARATOR

Patient will receive dual anti platelet asprin And clopidogrel

Drug: Antiplatelet Agents

Clopidogrel

ACTIVE COMPARATOR

Patient will receive dual anti platelet asprin And clopidogrel

Drug: Antiplatelet Agents

Warfarin

ACTIVE COMPARATOR

Patient will receive oral anticoagulation

Drug: Anticoagulants

Novel oral anticoagulant

ACTIVE COMPARATOR

Patient will receive oral anticoagulation

Drug: Anticoagulants

Interventions

Antiplatelet Agents DRUG

effect of dual antiplatelet in management of coronary artery ectasia

Asprin; Clopidogrel

Anticoagulants DRUG

effect of oral anticoagulants in management of coronary artery ectasia

Novel oral anticoagulant; Warfarin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Martina Gamil

Asyut, 23123, Egypt

Location

MeSH Terms

Conditions

Dilatation, Pathologic; Coronary Artery Disease

Interventions

Platelet Aggregation Inhibitors; Anticoagulants

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Hematologic Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Salwa R. Demitry, Professor

  Assiut University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 23, 2019
• First Posted: March 29, 2019
• Study Start: December 1, 2019
• Primary Completion: December 1, 2021
• Study Completion: February 1, 2022
• Last Updated: February 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

EG (1)