Clinical trial NCT06141252: Benefit of Hypothermia in OHCA Complicating AMI
Official title: Benefit of Hypothermia in Out-of-hospital Cardiac Arrest Complicating Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Out-Of-Hospital Cardiac Arrest
Myocardial Infarction, Acute
Hypothermia Neonatal
Keywords: Out-Of-Hospital Cardiac Arrest
Acute myocardial infarction
Hypothermia
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2023-11-21
Enrollment: 2925
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Death from any cause at hospital discharge
timeFrame: up to 30 days
Secondary outcomes:
measure: Poor neurological outcomesat hospital discharge
timeFrame: up to 30 days
Other outcomes:
Locations:
city: Yongin
country: Korea, Republic of
facility: Yongin Severance Hospitall, Yonsei University College of Medicine
state: Gyeonggi-do
Study officials:
affiliation: Yongin Severance Hospital, Yonsei University College of Medicine
name: Yongcheol Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.