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临床试验/NCT05399576
NCT05399576Unknown2 期

The Preventive Effect of Combined Intracoronary of Nicorandil and Verapamil on Myocardial Injury in Preioperative Period of PCI

The First Affiliated Hospital of Zhejiang Chinese Medical University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2022年5月17日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
发起方
入组人数
150
试验地点
1
主要终点
Incidence of periprocedural myocardial injury and infarction after PCI

研究概览

简要总结

Percutaneous coronary intervention (PCI) remains the major revascularization strategy for patients with obstructive coronary artery disease (CAD).However,in a substantial number of PCI cases for acute coronary syndrome (ACS) and chronic coronary syndrome (CCS),periprocedural myocardial injury or myocardial infarction (MI) occurs,both these PCI-related complications may be associated with an increased risk of future major adverse cardiovascular events (such as death, re-infarction, and revascularization).The incidence of periprocedural myocardial injury varies according to the different definition and cardiac biomarker .For 4th UDMI criteria with hs-cTn, 78% to 85% patients who undergoing elective PCI may suffer from periprocedural myocardial injury.

Experimental and clinical evidence highlight the abnormalities of the coronary microcirculation is one of the causes of myocardial ischemia.Coronary microvascular disturbances (CMD) have been associated with early stages of atherosclerosis even prior to any angiographic evidence of epicardial coronary stenosis, as well as to other cardiac pathologies such as myocardial hypertrophy and heart failure.

In this study, we try to conduct a double blinded, randomized, placebo-controlled trial,the aim of our trial is: (1) to observe whether the prophylactically intracoronary administration of nicorandil and verapamil could reduce the occurrence of periprocedural myocardial injury and infarction in CAD patients undergoing elective PCI.;(2) to observe whether the prophylactically intracoronary administration of nicorandil and verapamil has protective effect on coronary microcirculation after elective PCI.

详细描述

Simple randomization in a 1:1 ratio will be made in blocks of variable size according to a random numbers generated by Excel 2019 to divide the patients to treatment group (Nicorandil and verapamil) and control group (Saline). The primary end points are the incidence of periprocedural myocardial injury and 4a MI and the level of the IMR,secondary end points include levels of hs-cTnI, CK-MB ,NT-proBNP and hs-CRP before, and 24 hours following PCI, and major adverse cardiovascular events at day 30. SPSS 26.0 will be used, and P-value < .05 will be considered statistically signifificant.

研究设计

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

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 1.diagnosis of CHD with FFR<0.8;2.elective PCI;

排除标准

  • Patients with AMI, lesion at the opening of the main coronary artery,kidney dysfunction, Liver dysfunction,blood coagulation disorder ,NYHA III-IV,Degree II-III atrioventricular block,and restenosis after PCI,CABG will be excluded.

研究组 & 干预措施

Nicorandil and verapamil

Experimental

intracoronary of 2mg Nicorandil and 500ug verapamil

干预措施: Nicorandil (Drug)

saline

Placebo Comparator

intracoronary of 4ml saline

干预措施: Saline (Drug)

结局指标

主要结局

Incidence of periprocedural myocardial injury and infarction after PCI

时间窗: Within 24 hours after surgery

2.periprocedural myocardial injury was defined as hypersensitive troponin exceeding the upper limit of normal after surgery

次要结局

未报告次要终点

研究者

发起方
The First Affiliated Hospital of Zhejiang Chinese Medical University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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