Out-Of-Hospital Cardiac ArrestHypothermiaNCT06141252
Benefit of Hypothermia in OHCA Complicating AMI
A study testing Hypothermia in people with Out-Of-Hospital Cardiac Arrest and Myocardial Infarction, Acute, run by Yonsei University at 1 site in South Korea.
Trial summary
To determine the clinical effectiveness of hypothermia treatment in patients with out-of-hospital cardiac arrest complicating acute myocardial infarction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Out-Of-Hospital Cardiac Arrest, Myocardial Infarction, Acute, Hypothermia Neonatal
- What is being tested?
- Hypothermia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,925 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Nov 2023to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Out-of-hospital cardiac arrest event
Who cannot join
- Arrest of non-cardiac origin
- Age < 18 years
- Did not received primary PCI
- Hypothermia before CAG
- Obey mental status
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yongin Severance Hospitall, Yonsei University College of Medicine
Yongin, Gyeonggi-do, 16995
About this study
Official title: Benefit of Hypothermia in Out-of-hospital Cardiac Arrest Complicating Acute Myocardial Infarction
To determine the clinical effectiveness of hypothermia treatment in patients with out-of-hospital cardiac arrest complicating acute myocardial infarction.
Read the 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.
- Being tested
- Hypothermia
- Keywords
- Out-Of-Hospital Cardiac Arrest, Acute myocardial infarction, Hypothermia
- Medical subject headings
- Out-of-Hospital Cardiac Arrest, Myocardial Infarction, Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypothermiaDevice
Patients admitted with out-of-hospital cardiac arrest and treated with hypothermia
| Study group | Role | What they receive |
|---|---|---|
| Hypothermia | Experimental | Patients admitted with out-of-hospital cardiac arrest and treated with hypothermia Receives: Device: Hypothermia |
| No hypothermia | No intervention | Patients admitted with out-of-hospital cardiac arrest and treated without hypothermia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death from any cause at hospital discharge
Death from any cause at hospital discharge
Measured: up to 30 days
Secondary outcomes (1)
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.
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start15 Nov 2023
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Out-Of-Hospital Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 2,925 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SungA Bae, Yonsei University
- Investigators
- Yongcheol Kim, MD, PhD, Principal investigator, Yongin Severance Hospital, Yonsei University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06141252
- Sponsor's protocol ID
- Door-to-cooling timing in OHCA
- Acronym
- Hypothermia
- Status last verified
- Apr 2025
- First submitted
- 15 Nov 2023
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 18687513Berdowski 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.
PubMed 20828914Bobrow 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.
PubMed 20924010
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefit of Hypothermia in Out-of-hospital Cardiac Arrest Complicating Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT06141252
- Acronym / sponsor ID
- Hypothermia / Door-to-cooling timing in OHCA
- Keywords
- Out-Of-Hospital Cardiac Arrest, Acute myocardial infarction, Hypothermia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,925 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 21 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Hypothermia | Experimental | Device: HypothermiaPatients admitted with out-of-hospital cardiac arrest and treated with hypothermia |
| No hypothermia | No intervention | –Patients admitted with out-of-hospital cardiac arrest and treated without hypothermia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Out-of-hospital cardiac arrest event
Key exclusion criteria (5 listed)
- Arrest of non-cardiac origin
- Age < 18 years
- Did not received primary PCI
- Hypothermia before CAG
- Obey mental status
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HypothermiaPatients admitted with out-of-hospital cardiac arrest and treated with hypothermia | Device | Hypothermia |
Primary outcome
Death from any cause at hospital discharge
Time frame: up to 30 days
Death from any cause at hospital discharge
1 secondary outcome
Poor neurological outcomesat hospital discharge
Time frame: up to 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Background: PubMed 18687513Becker 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.
- Background: PubMed 20828914Berdowski 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.
- Background: PubMed 20924010Bobrow 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yongcheol Kim, MD, PhD principal investigator
Yongin Severance Hospital, Yonsei University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypothermia in people with Out-Of-Hospital Cardiac Arrest and Myocardial Infarction, Acute, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death from any cause at hospital discharge (time frame: up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06141252, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.