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Effect of Diltiazem on Coronary Artery Ectasia

Primary Purpose

Coronary Artery Ectasia

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
intracoronary administration of diltiazem
intracoronary injection of 5 mL saline
Sponsored by
Ankara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Ectasia

Eligibility Criteria

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

Inclusion Criteria: Patients with isolated coronary artery ectasia at least 1 major epicardial coronary artery

Exclusion Criteria:

Patients with known allergy to diltiazem acute coronary syndrome left ventricular systolic dysfunction significant valvular heart disease heart failure systolic blood pressure <90 mmHg heart rate <60 atrioventricular block (grade > I) severe liver or kidney failure significant coronary artery stenosis and patients on treatment with calcium channel blockers were excluded

Sites / Locations

  • Ankara University School Of Medicine, Department of Cardiology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Diltiazem

Saline

Arm Description

intracoronary diltiazem 5 milligrams which is diluted with 5 mL of saline

intracoronary saline 5 mL

Outcomes

Primary Outcome Measures

Myocardial blush grade
Myocardial blush grade which is a measure of myocardial perfusion will be analysed just after administration of intracoronary diltiazem.
TIMI (Thrombolysis in myocardial infarction) flow grade
TIMI (Thrombolysis in myocardial infarction) flow grade which is a measure of epicardial flow rate will be measured just after administration of intracoronary diltiazem
TIMI (Thrombolysis in myocardial infarction) frame count
TIMI (Thrombolysis in myocardial infarction) frame count which is a measure of epicardial flow rate will be analysed just after administration of intracoronary diltiazem

Secondary Outcome Measures

Full Information

First Posted
December 29, 2013
Last Updated
May 5, 2015
Sponsor
Ankara University
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1. Study Identification

Unique Protocol Identification Number
NCT02024919
Brief Title
Effect of Diltiazem on Coronary Artery Ectasia
Official Title
Short Term Effect of Diltiazem on Myocardial Perfusion in Patients With Isolated Coronary Artery Ectasia- a Prospective Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
Coronary artery ectasia (CAE) has been defined as localized or diffuse dilatation of epicardial coronary arteries more than 1.5 fold of adjacent normal segments. Isolated CAE constitutes minor portion of the total CAE cases, with an incidence of 0.1% to 0.79% in which coronary artery stenosis or severe valvular heart diseases are not present. CAE represents not only an anatomical variant but also a clinical constellation of coronary artery disease (CAD) like association with myocardial ischemia and acute coronary syndromes. Patients with CAE without significant coronary narrowing may still present with angina pectoris, positive stress tests, or acute coronary syndromes. Impaired epicardial and microvascular perfusion were demonstrated in ectatic coronary arteries. Myocardial blush grading (MBG) technique has been utilized in various conditions such as acute myocardial infarction, coronary artery ectasia, syndrome X and idiopathic dilated cardiomyopathy to evaluate myocardial perfusion. There is still no consensus for management of CAE. Previously improvement of coronary flow has been demonstrated by mibefradil in patients with slow coronary flow. A new trial is needed to explore the effect of calcium channel blockers (CCB) in isolated CAE. Diltiazem improves myocardial perfusion by blocking calcium channels in coronary arteries. This agent has been widely used in coronary catheter labs to prevent and treat no-reflow. The current study with prospective design was therefore set up to assess whether epicardial flow and tissue level perfusion would be improved by diltiazem in myocardial regions subtended by the ectatic coronary arteries among patients with isolated CAE.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diltiazem
Arm Type
Active Comparator
Arm Description
intracoronary diltiazem 5 milligrams which is diluted with 5 mL of saline
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
intracoronary saline 5 mL
Intervention Type
Drug
Intervention Name(s)
intracoronary administration of diltiazem
Intervention Type
Drug
Intervention Name(s)
intracoronary injection of 5 mL saline
Primary Outcome Measure Information:
Title
Myocardial blush grade
Description
Myocardial blush grade which is a measure of myocardial perfusion will be analysed just after administration of intracoronary diltiazem.
Time Frame
within 3 minutes after intracoronary diltiazem administration
Title
TIMI (Thrombolysis in myocardial infarction) flow grade
Description
TIMI (Thrombolysis in myocardial infarction) flow grade which is a measure of epicardial flow rate will be measured just after administration of intracoronary diltiazem
Time Frame
Within 3 minutes after intracoronary administration of diltiazem
Title
TIMI (Thrombolysis in myocardial infarction) frame count
Description
TIMI (Thrombolysis in myocardial infarction) frame count which is a measure of epicardial flow rate will be analysed just after administration of intracoronary diltiazem
Time Frame
within 3 minutes after intracoronary administration of diltiazem

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: Patients with isolated coronary artery ectasia at least 1 major epicardial coronary artery Exclusion Criteria: Patients with known allergy to diltiazem acute coronary syndrome left ventricular systolic dysfunction significant valvular heart disease heart failure systolic blood pressure <90 mmHg heart rate <60 atrioventricular block (grade > I) severe liver or kidney failure significant coronary artery stenosis and patients on treatment with calcium channel blockers were excluded
Facility Information:
Facility Name
Ankara University School Of Medicine, Department of Cardiology
City
Ankara
ZIP/Postal Code
06230
Country
Turkey

12. IPD Sharing Statement

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Effect of Diltiazem on Coronary Artery Ectasia

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