Effect of Diltiazem on Coronary Artery Ectasia

May 5, 2015 updated by: Özgür Ulaş Özcan, Ankara University

Short Term Effect of Diltiazem on Myocardial Perfusion in Patients With Isolated Coronary Artery Ectasia- a Prospective Clinical Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06230
        • Ankara University School Of Medicine, Department of Cardiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Diltiazem
intracoronary diltiazem 5 milligrams which is diluted with 5 mL of saline
Drug: intracoronary administration of diltiazem
Placebo Comparator: Saline
intracoronary saline 5 mL
Drug: intracoronary injection of 5 mL saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Myocardial blush grade
Time Frame: within 3 minutes after intracoronary diltiazem administration
Myocardial blush grade which is a measure of myocardial perfusion will be analysed just after administration of intracoronary diltiazem.
within 3 minutes after intracoronary diltiazem administration
TIMI (Thrombolysis in myocardial infarction) flow grade
Time Frame: Within 3 minutes after intracoronary administration of diltiazem
TIMI (Thrombolysis in myocardial infarction) flow grade which is a measure of epicardial flow rate will be measured just after administration of intracoronary diltiazem
Within 3 minutes after intracoronary administration of diltiazem
TIMI (Thrombolysis in myocardial infarction) frame count
Time Frame: within 3 minutes after intracoronary administration of diltiazem
TIMI (Thrombolysis in myocardial infarction) frame count which is a measure of epicardial flow rate will be analysed just after administration of intracoronary diltiazem
within 3 minutes after intracoronary administration of diltiazem

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

December 29, 2013

First Submitted That Met QC Criteria

December 30, 2013

First Posted (Estimate)

December 31, 2013

Study Record Updates

Last Update Posted (Estimate)

May 6, 2015

Last Update Submitted That Met QC Criteria

May 5, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AnkaraU1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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