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

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ClinicalTrials.gov Identifier: NCT03896321
Recruitment Status : Not yet recruiting
First Posted : March 29, 2019
Last Update Posted : March 29, 2019
Sponsor:
Information provided by (Responsible Party):
Martina Gamil Fathi, 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


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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

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




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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03896321


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

Locations
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Egypt
Martina Gamil Recruiting
Assiut, Egypt, 23123
Contact: Martina G. Fathi         
Sponsors and Collaborators
Assiut University
Investigators
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Study Director: Salwa R. Demitry, Professor Assiut University

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Responsible Party: Martina Gamil Fathi, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03896321     History of Changes
Other Study ID Numbers: Coronary Artery Ectasia
First Posted: March 29, 2019    Key Record Dates
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

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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:
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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
Clopidogrel
Platelet Aggregation Inhibitors
Anticoagulants
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs