跳至主要内容
临床试验/NCT02024919
NCT02024919已完成不适用

Short Term Effect of Diltiazem on Myocardial Perfusion in Patients With Isolated Coronary Artery Ectasia- a Prospective Clinical Study

Ankara University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2012年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
TIMI (Thrombolysis in myocardial infarction) flow grade

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with isolated coronary artery ectasia at least 1 major epicardial coronary artery

排除标准

  • 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

研究组 & 干预措施

Diltiazem

Active Comparator

intracoronary diltiazem 5 milligrams which is diluted with 5 mL of saline

干预措施: intracoronary administration of diltiazem (Drug)

Saline

Placebo Comparator

intracoronary saline 5 mL

干预措施: intracoronary injection of 5 mL saline (Drug)

结局指标

主要结局

TIMI (Thrombolysis in myocardial infarction) flow grade

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Özgür Ulaş Özcan

Dr

Ankara University

研究点 (1)

Loading locations...

相似试验