Benefit of Hypothermia in OHCA Complicating AMI

Not Applicable

Completed

• Conditions: Out-Of-Hospital Cardiac Arrest; Myocardial Infarction, Acute; Hypothermia Neonatal
• Interventions: Device: Hypothermia

• Registration Number: NCT06141252
• Lead Sponsor: Yonsei University

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.

Study Timeline

• Study Start: 2023-11-15
• Study First Submitted: 2023-11-15
• Study First Submitted QC: 2023-11-15
• Study First Posted: 2023-11-21
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-30
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2925

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hypothermia	Hypothermia	Patients admitted with out-of-hospital cardiac arrest and treated with hypothermia

Primary Outcome Measures

Name	Time	Method
Death from any cause at hospital discharge	up to 30 days	Death from any cause at hospital discharge

Secondary Outcome Measures

Name	Time	Method
Poor neurological outcomesat hospital discharge	up to 30 days	Poor neurological outcomes, which was defined as a Glasgow-Pittsburge Cerebral Performance Category (CPC) value at hospital discharge. The investigators determined the neurological outcome according to Pittsburgh CPC, which is a scale on 1 to 5. 1 is e.g. good cerebral performance: conscious, alert, able to work, might have mild neurological or physiological deficit contrast to 5 which is brain death.

Trial Locations

Locations (1)

Yongin Severance Hospitall, Yonsei University College of Medicine; 🇰🇷 Yongin, Gyeonggi-do, Korea, Republic of