Benefit of Hypothermia in OHCA Complicating AMI

NCT ID: NCT06141252

Last Updated: 2025-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2925 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-15

Study Completion Date

2023-12-30

Brief Summary

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

Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hypothermia

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

Group Type EXPERIMENTAL

Hypothermia

Intervention Type DEVICE

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

No hypothermia

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Hypothermia

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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SungA Bae

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yongcheol Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Yongin Severance Hospital, Yonsei University College of Medicine

Locations

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Yongin Severance Hospitall, Yonsei University College of Medicine

Yongin, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type BACKGROUND
PMID: 18687513 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20828914 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20924010 (View on PubMed)

Other Identifiers

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Door-to-cooling timing in OHCA

Identifier Type: -

Identifier Source: org_study_id

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