Benefit of Hypothermia in OHCA Complicating AMI

Yonsei University

Status: Completed

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

Treatments: Device: Hypothermia

Study type: Interventional

Funder types: Other

Identifiers

NCT06141252

Door-to-cooling timing in OHCA

Details and patient eligibility

About

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

Full 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.

Enrollment: 2,925 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

2,925 participants in 2 patient groups

Hypothermia

Experimental group

Description:

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

Treatment:

Device: Hypothermia

No hypothermia

No Intervention group

Description:

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