Effect of Diltiazem on Coronary Artery Ectasia

NCT ID: NCT02024919

Last Updated: 2015-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2015-05-31

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.

Conditions

Coronary Artery Ectasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

Diltiazem

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

Group Type: ACTIVE_COMPARATOR

intracoronary administration of diltiazem

Intervention Type: DRUG

Saline

intracoronary saline 5 mL

Group Type: PLACEBO_COMPARATOR

intracoronary injection of 5 mL saline

Intervention Type: DRUG

Interventions

intracoronary administration of diltiazem

Intervention Type: DRUG

intracoronary injection of 5 mL saline

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ankara University

OTHER

Sponsor Role: lead

Responsible Party

Özgür Ulaş Özcan

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ankara University School Of Medicine, Department of Cardiology

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

AnkaraU1

Identifier Type: -

Identifier Source: org_study_id