Effect of Diltiazem on Coronary Artery Ectasia
- Conditions
- Coronary Artery Ectasia
- Interventions
- Drug: intracoronary injection of 5 mL salineDrug: intracoronary administration of diltiazem
- Registration Number
- NCT02024919
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
Patients with isolated coronary artery ectasia at least 1 major epicardial coronary artery
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Saline intracoronary injection of 5 mL saline intracoronary saline 5 mL Diltiazem intracoronary administration of diltiazem intracoronary diltiazem 5 milligrams which is diluted with 5 mL of saline
- Primary Outcome Measures
Name Time Method TIMI (Thrombolysis in myocardial infarction) flow grade 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 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
Myocardial blush grade 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Ankara University School Of Medicine, Department of Cardiology
š¹š·Ankara, Turkey