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Clinical Trials/NCT06141252
NCT06141252
Completed
Not Applicable

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

Yonsei University1 site in 1 country2,925 target enrollmentNovember 15, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Out-Of-Hospital Cardiac Arrest
Sponsor
Yonsei University
Enrollment
2925
Locations
1
Primary Endpoint
Death from any cause at hospital discharge
Status
Completed
Last Updated
last year

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
November 15, 2023
End Date
December 30, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

SungA Bae

Clinical Professor

Yonsei University

Eligibility Criteria

Inclusion Criteria

  • Out-of-hospital cardiac arrest event

Exclusion Criteria

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

Outcomes

Primary Outcomes

Death from any cause at hospital discharge

Time Frame: up to 30 days

Death from any cause at hospital discharge

Secondary Outcomes

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

Study Sites (1)

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