Effects of Nicorandil on Cardiac Sympathetic Nerve Activity and Distribution in Patients With Acute Myocardial Infarction Treated With Primary Percutaneous Coronary Intervention
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 80
- 主要终点
- Comparison of the delayed heart/mediastinum count (H/M) ratio
研究概览
简要总结
The investigators evaluate the effects of intracoronary and intravenous administration of nicorandil on cardiac sympathetic nerve activity and distribution in patients with acute myocardial infarction undergoing primary percutaneous coronary intervention
详细描述
Reperfusion injury might occur in patients with acute ST segment elevation myocardial infarction undergoing the primary percutaneous coronary intervention(P-PCI),characterized by myocardial stunning, reperfusion-induced arrhythmia, microvascular dysfunction and injury of cardiac sympathetic nerve, etc.
Nicorandil is an antianginal agent with a dual mechanism of action: nitrate and K+ATP channel opener. The nitrate action causes vasodilation of systemic veins and epicardial coronary arteries, while the adenosine triphosphate (ATP)-sensitive potassium channel opener action causes vasodilation of peripheral and coronary resistance arterioles. Nicorandil not only decreases preload and afterload but also increases coronary blood flow.
The study will compare the effectiveness between nicorandil and placebo of preventing the reperfusion injury especially injury of cardiac sympathetic nerve in patients with acute ST segment elevation myocardial infarction undergoing the P-PCI.It is intended that before reperfusion injury ,nicorandil which was early used by intracoronary injection could prevent and release the microcirculatory spasm, release the coronary microvascular endothelial swelling,decrease embolism of atherosclerotic debris and thrombus formation,moreover,it could reduces the release of norepinephrine from sympathetic endings of the heart directly.So,it could decrease the phenomenon of no-reflow/slow reflow,reperfusion-induced arrhythmia and injury of cardiac sympathetic nerve.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •acute ST-segment elevation myocardial infarction within 12 hours of symptom onset;
- •Age20-80,All genders
- •anterior myocardial infarction
- •The first myocardial infarction
- •The infarct-related artery(IRA) is totally occlusive
- •Blood pressure is higher than 90/60 millimeters of mercury（mmHg）
- •The time from myocardial infarction onset to reach the hospital is less than 12 hs
排除标准
- •kidney dysfunction (creatinine >2 mg/dl),
- •History of previous liver disease,
- •Cardiogenic shock,
- •History of myocardial infarction (MI)
- •History of coronary artery bypass grafting
- •History of allergic response to drugs
- •Severe hypovolemia
研究组 & 干预措施
Nicorandil
Patients who received intracoronary and intravenous nicorandil before and after reperfusion with primary percutaneous coronary intervention
干预措施: nicorandil (Drug)
Placebo （normal saline）
Patients who received intracoronary and intravenous placebo before and after reperfusion with primary percutaneous coronary intervention
干预措施: Placebo（normal saline） (Drug)
结局指标
主要结局
Comparison of the delayed heart/mediastinum count (H/M) ratio
时间窗: 10 days after primary PCI
The delayed heart/mediastinum count (H/M) ratio was determined from 123I-meta-iodobenzylguanidine (MIBG) images
次要结局
- The total defect score (TDS)(7 days after primary PCI)
- Rate fo complete ST-segment resolution(2 hours after primary PCI)
- Rate of unplanned hospitalization for heart failure(6 months after primary PCI)
- The washout rate (WR)(10 days after primary PCI)
- Rate of slow re-flow/no-reflow phenomenon(5 minutes after primary PCI)