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临床试验/NCT04632121
NCT04632121Unknown不适用

Early Administration of Oral Nicorandil in ST Elevation Myocardial Infarction Patients Undergoing Primary Percutaneous Coronary Intervention: A Randomized Controlled Trial

Ahmed Abdel Nasser Abdel Rady0 个研究点目标入组 300 人开始时间: 2021年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
300
主要终点
Angiographic evidence of epicardial successful reperfusion

研究概览

简要总结

  • To study the effects of early oral administration of nicorandil in the setting of PPCI among STEMI patients on early angiographic, electrocardiographic, echocardiographic and hard clinical outcomes.
  • To assess the possible benefits of nicorandil on myocardial reperfusion through LGE- CMR substudy after 3 months.

详细描述

Nicorandil is a nicotinamide ester that dilates peripheral and coronary resistance vessels via action on ATP-sensitive potassium channels and possesses a nitrate moiety that promotes systemic venous and coronary vasodilation. As a result of these dual actions, nicorandil reduces preload and afterload and results in an increase in coronary blood flow. In addition to these effects, nicorandil may have cardioprotective actions mediated through the activation of potassium channel .

Previous study on the effect of nicorandil on patients with stable angina has shown significant improvement in outcome due to a reduction in major coronary events.

Acute occlusion of the coronary artery in the STEMI patient subjects the myocardium supplied by that vessel to acute myocardial ischemia, thereby demarcating the area at risk (AAR) of potential MI, should the acute coronary occlusion be sustained or permanent. If the period of acute myocardial ischemia is prolonged (more than 20 minutes) a "wave front" of cardiomyocyte death begins in the subendocardium and extends transmurally over time toward the epicardium.

The deprivation of oxygen and nutrient supply results in a series of abrupt biochemical and metabolic changes within the myocardium. The absence of oxygen halts oxidative phosphorylation, leading to mitochondrial membrane depolarization, ATP depletion, and inhibition of myocardial contractile function.

Ischemia-Reperfusion injury (IRI) is defined as the paradoxical exacerbation of cellular dysfunction and death, following restoration of blood flow to previously ischemic tissues. Reestablishment of blood flow is essential to salvage ischemic tissues. However reperfusion itself paradoxically causes further damage, threatening function and viability of the organ.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
16 Years 至 90 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with STEMI eligible for PPCI.

排除标准

  • Patients undergoing other reperfusion strategies, including fibrinolysis, rescue PCI or pharmacoinvasive PCI.
  • Patients presenting with Cardiogenic shock or symptomatic hypotension (BP< 90/60 mmHg)
  • Patients who have contraindications for nicorandil e.g. advanced hepatic disease.
  • Patients not consenting to the study protocol.

研究组 & 干预措施

Group A

will receive standard treatment + 20 mg nicorandil prior to PPCI, and then maintained on 20 mg b.i.d for 3 months .

干预措施: Nicorandil 20 MG (Drug)

结局指标

主要结局

Angiographic evidence of epicardial successful reperfusion

时间窗: 1 day around PCI

Angiographic evidence of epicardil successful reperfusion including; TIMI flow grade, and TIMI frame count.

Angiographic evidence of tissue-level successful reperfusion

时间窗: 1 day around PCI

Angiographic evidence of tissue-level successful reperfusion (Myocardial blush grade).

次要结局

  • Electrocardiographic measures of repolarization dispersion(after 90 minutes of PPCI)
  • Echocardiographic measures of LV recovery(before discharge and at 3 months after index event.)
  • Speckle tracking for global longitudinal strain of left ventricle(before discharge and at 3 months after index event)

研究者

发起方
Ahmed Abdel Nasser Abdel Rady
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ahmed Abdel Nasser Abdel Rady

Principal Investigator

Assiut University

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