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临床试验/NCT06141252
NCT06141252已完成不适用

Benefit of Hypothermia in Out-of-hospital Cardiac Arrest Complicating Acute Myocardial Infarction

Yonsei University2 个研究点 分布在 1 个国家目标入组 2,925 人开始时间: 2023年11月15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
2,925
试验地点
2
主要终点
Death from any cause at hospital discharge

研究概览

简要总结

To determine the clinical effectiveness of hypothermia treatment in patients with out-of-hospital cardiac arrest complicating acute myocardial infarction.

详细描述

Out-of-hospital cardiac arrest (OHCA) is a leading cause of mortality worldwide. Due to significant improvement in the management of patients with OHCA, an increasing number of initially resuscitated patients are being admitted to hospitals. Nevertheless, OHCA remains associated with a poor prognosis, with a survival rate of approximately 8.8% to hospital discharge. Moreover, international registry data have indicated that favorable neurological outcome at hospital discharge or 30 days after OHCA is only 2.8-18.2% across all registries.

The majority of adult cardiac arrest cases are associated with obstructive coronary artery disease. Thus, current guideline recommended that immediate angiography and primary revascularization in all patients with resuscitated cardiac arrest and ST-segment elevation on electrocardiography, and also in patients with resuscitated cardiac arrest without ST-segment elevation, but with high probability of acute coronary occlusion. However, even after prompt restoration of blood flow, a substantial proportion of patients with myocardial infarction (MI) experience extensive necrosis. The application of hypothermia in patients with acute MI focuses on the reducing energy consumption at cardiac level, a factor consistently linked to diminished infarction size in animal study. However, in a recent meta-analysis of randomized trials comparing different strategies for therapeutic hypothermia adjunctive to percutaneous coronary intervention (PCI) versus standard of care in patients with acute MI, faille to demonstrate clear benefit. It is important to note, however, these randomized trials were underpowered and as a results, they were unable to draw firm conclusions regarding the impact of therapeutic hypothermia.

Therefore, this study aimed to investigate the impact of therapeutic hypothermia on clinical outcomes in patients who underwent primary PCI for acute MI after OHCA.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Out-of-hospital cardiac arrest event

排除标准

  • Arrest of non-cardiac origin
  • Age < 18 years
  • Did not received primary PCI
  • Hypothermia before CAG
  • Obey mental status

结局指标

主要结局

Death from any cause at hospital discharge

时间窗: up to 30 days

Death from any cause at hospital discharge

次要结局

  • Poor neurological outcomesat hospital discharge(up to 30 days)

研究者

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

SungA Bae

Clinical Professor

Yonsei University

研究点 (2)

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