Benefit of Hypothermia in OHCA Complicating AMI

Out-Of-Hospital Cardiac Arrest Clinical Trial

— Hypothermia  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06141252
• Other study ID #: Door-to-cooling timing in OHCA
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 15, 2023
• Est. completion date: December 30, 2023

Study information

• Verified date: November 2023
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3000
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Hypothermia
Patients admitted with out-of-hospital cardiac arrest and treated with hypothermia

Locations

Country	Name	City	State
Korea, Republic of	Yongin Severance Hospitall, Yonsei University College of Medicine	Yongin	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death from any cause at hospital discharge	Death from any cause at hospital discharge	up to 30 days
Secondary	Poor neurological outcomesat hospital discharge	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.	up to 30 days