Benefit of Hypothermia in OHCA Complicating AMI

Sponsor

Yonsei University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT06141252

Collaborator

(none)

3,000

Enrollment

Location

Arms

1.5

Anticipated Duration (Months)

2029.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Out-Of-Hospital Cardiac Arrest Myocardial Infarction, Acute Hypothermia Neonatal	Device: Hypothermia	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

3000 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

The investigators aim to compare and evaluate the effects of therapeutic hypothermia versus standard care on clinical outcomes, such as survival rates and neurological function, in patients with out-of-hospital cardiac arrest complicating acute myocardial infarction.The investigators aim to compare and evaluate the effects of therapeutic hypothermia versus standard care on clinical outcomes, such as survival rates and neurological function, in patients with out-of-hospital cardiac arrest complicating acute myocardial infarction.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 15, 2023

Anticipated Primary Completion Date :

Dec 30, 2023

Anticipated Study Completion Date :

Dec 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hypothermia Patients admitted with out-of-hospital cardiac arrest and treated with hypothermia	Device: Hypothermia Patients admitted with out-of-hospital cardiac arrest and treated with hypothermia
No Intervention: No hypothermia Patients admitted with out-of-hospital cardiac arrest and treated without hypothermia

Arm

Intervention/Treatment

Experimental: Hypothermia

Patients admitted with out-of-hospital cardiac arrest and treated with hypothermia

Device: Hypothermia

Patients admitted with out-of-hospital cardiac arrest and treated with hypothermia

No Intervention: No hypothermia

Patients admitted with out-of-hospital cardiac arrest and treated without hypothermia

Outcome Measures

Primary Outcome Measures

Death from any cause at hospital discharge [up to 30 days]
Death from any cause at hospital discharge

Secondary Outcome Measures

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.