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临床试验/NCT05415085
NCT05415085已完成不适用

Culprit-first Versus Culprit-last Approach During Primary Percutaneous Coronary Intervention in Patients With ST-elevation Myocardial Infarction: A Randomized Controlled Study

Shaare Zedek Medical Center2 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2021年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
106
试验地点
2
主要终点
Needle-to-balloon time of 10 minutes or less

研究概览

简要总结

The aim of this study is to assess the impact of culprit-first versus culprit-last percutaneous coronary intervention on the door to balloon time and clinical outcomes in patients with ST-elevation myocardial infarction.

详细描述

Ischemic heart disease (IHD) is the single most common cause of death and its frequency is increasing globally. It is estimated that IHD is the cause of 1.8 million deaths or 20% of all deaths in Europe. Despite advancements in the fields of rapid diagnosis and in treatment strategies, the morbidity, and mortality in patients with ST-segment myocardial infarction remains substantial, with an estimated mortality rate of 4-12% according to registries of the ESC countries. According to the 2017 European Society of Cardiology (ESC) guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation (STEMI), there is a level 1 recommendation with a level of evidence A for primary percutaneous coronary intervention (PPCI) strategy in patients with STEMI, and this strategy is preferred over fibrinolytic therapy. In addition, the ESC guidelines recommend a first medical contact to reperfusion time within 60 minutes in STEMI patients for primary PCI-capable centers. This recommendation is supported by a recently published study that showed shortening door to balloon (D2B) time was significantly associated with survival benefit. Based on the recommendation for maximal D2B time in STEMI patients to be 60 minutes, many countries and institutions worldwide have established programs, among them the national program for quality indicators by the Israeli ministry of health, to shorten D2B times. According to data published by the Israeli ministry of health in the year 2018, 88% of STEMI patients had a D2B time of <90 minutes. The common practice during PPCI is to complete diagnostic angiography of the whole coronary tree before performing culprit-vessel revascularization. This practice is not evidence-based and current guidelines do not prioritize full diagnostic angiography over culprit-vessel revascularization first. As was found in previous studies, this practice might result in delaying revascularization by 4-8 minutes in D2B time. This delay might potentially lead to worse outcomes in STEMI patients, although not proven in the above-cited studies.

研究设计

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

入排标准

年龄范围
18 Years 至 120 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients presenting with STEMI who are eligible for PPCI

排除标准

  • Cardiac arrest
  • Cardiopulmonary resuscitation or extracorporeal membrane oxygenation on arrival to the catheterization laboratory
  • Prior coronary artery bypass grafting surgery

结局指标

主要结局

Needle-to-balloon time of 10 minutes or less

时间窗: through study completion, an average of 1 year

Change in needle-to-balloon time in minutes

次要结局

  • Need for hemodynamic (mechanical/medical) support during PCI(through study completion, an average of 1 year)
  • Need for respiratory support during PCI(through study completion, an average of 1 year)
  • Rate of failed PCI(through study completion, an average of 1 year)

研究者

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

Nir Levi

Physician

Shaare Zedek Medical Center

研究点 (2)

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