Benefit of Hypothermia in OHCA Complicating AMI

NCT06141252 | Completed

• 1 other identifier: Door-to-cooling timing in OHCA
• Study Type: interventional
• Target: 2,925
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

Out-Of-Hospital Cardiac Arrest; Acute myocardial infarction; Hypothermia

Outcome Measures

Primary Outcomes (1)

• Death from any cause at hospital discharge

  Death from any cause at hospital discharge

  up to 30 days

Secondary Outcomes (1)

• Poor neurological outcomesat hospital discharge

  up to 30 days

Study Arms (2)

Hypothermia

EXPERIMENTAL

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

Device: Hypothermia

No hypothermia

NO INTERVENTION

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

Interventions

Hypothermia DEVICE

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

Hypothermia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Out-of-hospital cardiac arrest event

You may not qualify if:

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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yongin Severance Hospitall, Yonsei University College of Medicine

Yongin, Gyeonggi-do, 16995, South Korea

Location

Related Publications (3)

• Becker L, Gold LS, Eisenberg M, White L, Hearne T, Rea T. Ventricular fibrillation in King County, Washington: a 30-year perspective. Resuscitation. 2008 Oct;79(1):22-7. doi: 10.1016/j.resuscitation.2008.06.019. Epub 2008 Aug 6.

  PMID: 18687513 BACKGROUND

• Berdowski J, Berg RA, Tijssen JG, Koster RW. Global incidences of out-of-hospital cardiac arrest and survival rates: Systematic review of 67 prospective studies. Resuscitation. 2010 Nov;81(11):1479-87. doi: 10.1016/j.resuscitation.2010.08.006. Epub 2010 Sep 9.

  PMID: 20828914 BACKGROUND

• Bobrow BJ, Spaite DW, Berg RA, Stolz U, Sanders AB, Kern KB, Vadeboncoeur TF, Clark LL, Gallagher JV, Stapczynski JS, LoVecchio F, Mullins TJ, Humble WO, Ewy GA. Chest compression-only CPR by lay rescuers and survival from out-of-hospital cardiac arrest. JAMA. 2010 Oct 6;304(13):1447-54. doi: 10.1001/jama.2010.1392.

  PMID: 20924010 BACKGROUND

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest; Myocardial Infarction; Hypothermia

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases; Myocardial Ischemia; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Body Temperature Changes; Signs and Symptoms

Study Officials

• Yongcheol Kim, MD, PhD

  Yongin Severance Hospital, Yonsei University College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: 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.

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: November 21, 2023
• Study Start: November 15, 2023
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)