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Completed

NCT Number: NCT06141252

Benefit of Hypothermia in OHCA Complicating AMI

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

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Key information

Conditions

Out-Of-Hospital Cardiac Arrest Body Temperature Changes Cardiovascular Diseases Heart Arrest Heart Diseases Hypothermia Hypothermia Neonatal Infarction Ischemia Myocardial Infarction Myocardial Infarction, Acute Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yongin Severance Hospitall, Yonsei University College of Medicine

Yongin, Gyeonggi-do, 16995, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hypothermia

Device

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

Primary outcomes

  1. Death from any cause at hospital discharge

    Time frame: up to 30 days

    Death from any cause at hospital discharge

Secondary outcomes

  1. Poor neurological outcomesat hospital discharge

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

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

Acronym: Hypothermia

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Nov 21, 2023
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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