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Effect of Diltiazem on Coronary Artery Ectasia

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ClinicalTrials.gov Identifier: NCT02024919
Recruitment Status : Completed
First Posted : December 31, 2013
Last Update Posted : May 6, 2015
Sponsor:
Information provided by (Responsible Party):
Özgür Ulaş Özcan, Ankara University

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.


Condition or disease Intervention/treatment Phase
Coronary Artery Ectasia Drug: intracoronary administration of diltiazem Drug: intracoronary injection of 5 mL saline Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : June 2012
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015


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



Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02024919


Locations
Turkey
Ankara University School Of Medicine, Department of Cardiology
Ankara, Turkey, 06230
Sponsors and Collaborators
Ankara University

Responsible Party: Özgür Ulaş Özcan, Dr, Ankara University
ClinicalTrials.gov Identifier: NCT02024919     History of Changes
Other Study ID Numbers: AnkaraU1
First Posted: December 31, 2013    Key Record Dates
Last Update Posted: May 6, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Dilatation, Pathologic
Coronary Aneurysm
Pathological Conditions, Anatomical
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Aneurysm
Vascular Diseases
Diltiazem
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents