An interventional study of intracoronary administration of diltiazem and intracoronary injection of 5 mL saline in Coronary Artery Ectasia, sponsored by Ankara University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-05-06.
Sponsored by Ankara University · Not applicable, Interventional, and Diagnostic
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.
31 studies on the registry are indexed under Coronary Aneurysm; 11 are open to participants now.
This study's enrollment of 60 is below the median of 100 across 17 interventional studies indexed under Coronary Aneurysm.
Browse Coronary Aneurysm studies →Ankara University is the lead sponsor of 312 studies on the registry; 68 are open to participants now.
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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
intracoronary diltiazem 5 milligrams which is diluted with 5 mL of saline
Drug: intracoronary administration of diltiazem
intracoronary saline 5 mL
Drug: intracoronary injection of 5 mL saline
Myocardial blush grade
Myocardial blush grade which is a measure of myocardial perfusion will be analysed just after administration of intracoronary diltiazem.
Time frame: within 3 minutes after intracoronary diltiazem administration
TIMI (Thrombolysis in myocardial infarction) flow grade
TIMI (Thrombolysis in myocardial infarction) flow grade which is a measure of epicardial flow rate will be measured just after administration of intracoronary diltiazem
Time frame: Within 3 minutes after intracoronary administration of diltiazem
TIMI (Thrombolysis in myocardial infarction) frame count
TIMI (Thrombolysis in myocardial infarction) frame count which is a measure of epicardial flow rate will be analysed just after administration of intracoronary diltiazem
Time frame: within 3 minutes after intracoronary administration of diltiazem
This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.
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Ankara University