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

• ClinicalTrials.gov Identifier: NCT03896321
• Recruitment Status: Unknown
• First Posted: March 29, 2019
• Last Update Posted: March 29, 2019
• Sponsor: Assiut University
• Information provided by (Responsible Party): Martina Gamil Fathi, Assiut University

Study Description

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

Condition or disease	Intervention/treatment	Phase
Ectasia; Coronary Artery Disease	Drug: Antiplatelet Agents; Drug: Anticoagulants	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Coronary Artery Ectasia in Elective Coronary Angiography : Predictors, Outcomes and Management
• Estimated Study Start Date: April 1, 2019
• Estimated Primary Completion Date: April 1, 2020
• Estimated Study Completion Date: October 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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)
2. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Contacts

Contact: Martina G. Fathi; +201211253364; martena_nona2000@yahoo.com

Locations

Egypt

Martina Gamil

Assiut, Egypt, 23123

Contact: Martina G. Fathi

Sponsors and Collaborators

Assiut University

Investigators

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

More Information

• Responsible Party: Martina Gamil Fathi, Principal Investigator, Assiut University
• ClinicalTrials.gov Identifier: NCT03896321
• Other Study ID Numbers: Coronary Artery Ectasia
• First Posted: March 29, 2019
• Last Update Posted: March 29, 2019
• Last Verified: March 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

• 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

Additional relevant MeSH terms:

Coronary Artery Disease; Coronary Aneurysm; Dilatation, Pathologic; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathological Conditions, Anatomical; Aneurysm; Anticoagulants; Platelet Aggregation Inhibitors