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

Primary Purpose

Ectasia, Coronary Artery Disease

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Antiplatelet Agents
Anticoagulants
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ectasia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Martina Gamil

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Asprin

Clopidogrel

Warfarin

Novel oral anticoagulant

Arm Description

Patient will receive dual anti platelet asprin And clopidogrel

Patient will receive dual anti platelet asprin And clopidogrel

Patient will receive oral anticoagulation

Patient will receive oral anticoagulation

Outcomes

Primary Outcome Measures

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)
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

Secondary Outcome Measures

Full Information

First Posted
March 23, 2019
Last Updated
March 28, 2019
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03896321
Brief Title
Coronary Artery Ectasia in Elective Coronary Angiography : Predictors, Outcomes and Management
Official Title
Coronary Artery Ectasia in Elective Coronary Angiography : Predictors, Outcomes and Management
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2019 (Anticipated)
Primary Completion Date
April 1, 2020 (Anticipated)
Study Completion Date
October 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

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

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ectasia, Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Asprin
Arm Type
Active Comparator
Arm Description
Patient will receive dual anti platelet asprin And clopidogrel
Arm Title
Clopidogrel
Arm Type
Active Comparator
Arm Description
Patient will receive dual anti platelet asprin And clopidogrel
Arm Title
Warfarin
Arm Type
Active Comparator
Arm Description
Patient will receive oral anticoagulation
Arm Title
Novel oral anticoagulant
Arm Type
Active Comparator
Arm Description
Patient will receive oral anticoagulation
Intervention Type
Drug
Intervention Name(s)
Antiplatelet Agents
Intervention Description
effect of dual antiplatelet in management of coronary artery ectasia
Intervention Type
Drug
Intervention Name(s)
Anticoagulants
Intervention Description
effect of oral anticoagulants in management of coronary artery ectasia
Primary Outcome Measure Information:
Title
Efficacy of dual antiplatelet therapy vs oral anticoagulants in patients with CAE - occurance of major adverse cardiovascular events
Description
Efficacy endpoints defined as the occurance of major adverse cardiovascular events (MACE)
Time Frame
6 months
Title
safety of dual antiplatelet therapy vs oral anticoagulants in patients with CAE - occurance of major or minor bleeding
Description
safety endpoints of occurance of major or minor bleeding
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martina G. Fathi
Phone
+201211253364
Email
martena_nona2000@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salwa R. Demitry, Professor
Organizational Affiliation
Assiut University
Official's Role
Study Director
Facility Information:
Facility Name
Martina Gamil
City
Assiut
ZIP/Postal Code
23123
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martina G. Fathi

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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