Effect of Diltiazem on Coronary Artery Ectasia

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.

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Key information

Conditions

Coronary Artery Ectasia Aneurysm Cardiovascular Diseases Coronary Aneurysm Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara University School Of Medicine, Department of Cardiology

Ankara, 06230, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intracoronary administration of diltiazem

Drug

intracoronary injection of 5 mL saline

Drug

Primary outcomes

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.
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
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

Sponsors and collaborators

Lead sponsor

Ankara University

Other

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2015
Study completion: 2015
First posted: Dec 31, 2013
Registry last updated: May 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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