Effect of Diltiazem on Coronary Artery Ectasia
|ClinicalTrials.gov Identifier: NCT02024919|
Recruitment Status : Completed
First Posted : December 31, 2013
Last Update Posted : May 6, 2015
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
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|
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02024919
|Ankara University School Of Medicine, Department of Cardiology|
|Ankara, Turkey, 06230|