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Effect of Diltiazem on Coronary Artery Ectasia

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Ankara University
Sponsor:
Information provided by (Responsible Party):
Özgür Ulaş Özcan, Ankara University
ClinicalTrials.gov Identifier:
NCT02024919
First received: December 29, 2013
Last updated: February 25, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Coronary Artery Ectasia
Drug: intracoronary administration of diltiazem
Drug: intracoronary injection of 5 mL saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Official Title: Short Term Effect of Diltiazem on Myocardial Perfusion in Patients With Isolated Coronary Artery Ectasia- a Prospective Clinical Study

Resource links provided by NLM:


Further study details as provided by Ankara University:

Primary Outcome Measures:
  • Myocardial blush grade [ Time Frame: within 3 minutes after intracoronary diltiazem administration ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    TIMI (Thrombolysis in myocardial infarction) frame count which is a measure of epicardial flow rate will be analysed just after administration of intracoronary diltiazem


Estimated Enrollment: 40
Study Start Date: June 2012
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02024919

Contacts
Contact: Ozgur U Ozcan, MD 00903125082410 ozgurulasozcan@yahoo.com.tr

Locations
Turkey
Ankara University School Of Medicine, Department of Cardiology Recruiting
Ankara, Turkey, 06230
Contact: Ozgur U Ozcan, MD    00903125082410    ozgurulasozcan@yahoo.com.tr   
Sponsors and Collaborators
Ankara University
  More Information

No publications provided

Responsible Party: Özgür Ulaş Özcan, Dr, Ankara University
ClinicalTrials.gov Identifier: NCT02024919     History of Changes
Other Study ID Numbers: AnkaraU1
Study First Received: December 29, 2013
Last Updated: February 25, 2014
Health Authority: Turkey: Ministry of Health

Additional relevant MeSH terms:
Dilatation, Pathologic
Pathological Conditions, Anatomical
Diltiazem
Antihypertensive Agents
Calcium Channel Blockers
Cardiovascular Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on November 24, 2014