Acute Myocardial Infarction Complicated With Cardiogenic ShockHOPE-CSNCT07186972
Evaluation of MTH in PCI Under VA-ECMO for AMICS
A study testing Mild therapeutic hypothermia in people with Acute Myocardial Infarction Complicated With Cardiogenic Shock and Mild Therapeutic Hypothermia, run by Beijing Anzhen Hospital.
Trial summary
This study is a randomized controlled trial conducted at Beijing Anzhen Hospital, Capital Medical University. The primary objective is to assess the efficacy of mild therapeutic hypothermia in reducing infarct size and improving cardiac function in patients receiving percutaneous coronary intervention under… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction Complicated With Cardiogenic Shock, Mild Therapeutic Hypothermia, Venous-arterial Extracorporeal Membrane Oxygenation
- What is being tested?
- Mild therapeutic hypothermia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients diagnosed with acute myocardial infarction complicated by cardiogenic shock who undergo emergency percutaneous coronary intervention under venoarterial extracorporeal membrane oxygenation support and endotracheal intubation.
- Patients diagnosed with anterior wall myocardial infarction.
- Aged ≥18 years.
Who cannot join
- Cardiogenic shock lasting more than 12 hours or a history of chronic congestive heart failure.
- History of prior coronary artery intervention, coronary artery bypass grafting, heart transplantation, heart-lung transplantation, or left ventricular assist device implantation.
- Cardiogenic shock associated with mechanical complications of acute myocardial infarction, such as ventricular septal rupture, acute mitral regurgitation, acute ventricular septal defect, and cardiac tamponade.
- Refractory out-of-hospital cardiac arrest or cardiopulmonary resuscitation lasting longer than 45 minutes.
- Known end-stage renal disease (e.g., on dialysis or post-kidney transplantation) or severe liver failure (e.g., cirrhosis or acute hepatitis).
- Contraindications to hypothermia therapy, such as cryoglobulinemia, sickle cell disease, cold agglutinin disease, and vasospastic disorders (e.g., Raynaud's disease and thromboangiitis obliterans).
Show all 10Show fewer
- Refusal to undergo 99mTc-sestamibi single photon emission tomography imaging or presence of known or suspected contraindications to 99mTc-sestamibi single photon emission tomography imaging.
- Pregnency.
- Currently participation in other interventional clinical trials.
- Refusal to sign informed consent related to this trial.
About this study
Official title: Evaluation of Mild Therapeutic Hypothermia in Percutaneous Coronary Intervention Under Venous-arterial Extracorporeal Membrane Oxygenation for Acute Myocardial Infarction Complicated With Cardiogenic Shock
This study is a randomized controlled trial conducted at Beijing Anzhen Hospital, Capital Medical University. The primary objective is to assess the efficacy of mild therapeutic hypothermia in reducing infarct size and improving cardiac function in patients receiving percutaneous coronary intervention under venous-arterial extracorporeal membrane oxygenation for acute myocardial infarction complicated with cardiogenic shock. Secondary objectives include evaluating the safety of mild therapeutic hypothermia and its impact on venous-arterial extracorporeal membrane oxygenation weaning success and short-term survival.
- Conditions
- Acute Myocardial Infarction Complicated With Cardiogenic Shock, Mild Therapeutic Hypothermia, Venous-arterial Extracorporeal Membrane Oxygenation
- Being tested
- Mild therapeutic hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mild therapeutic hypothermiaProcedure or surgery
Before percutaneous coronary intervention, cooling was maintained with venous-arterial extracorporeal membrane oxygenation in patients receiving mild therapeutic hypothermia. By protocol, cooling down to the target temperature of 33°C-34°C was set at the maximum possible cooling rate. After the target temperature was reached, it was maintained for 24 hours with the temperature regulation function of the extracorporeal membrane oxygenation system by central temperature measurement in the urinary bladder. After 24 hours, rewarming was initiated with a speed of 0.25°C/h to a target temperature of 36.5℃ (± 0.3℃). To avoid shivering in the mild therapeutic hypothermia group, the patients were treated with a protocol including deep sedation and optional muscle relaxation.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Maintaining a target temperature of 36.5℃ (±0.3℃) during percutaneous coronary intervention |
| Mild therapeutic hypothermia | Experimental | Cooling down to a target temperature of 33.0°C-34.0°C before percutaneous coronary intervention, and then rewarming was initiated after 24 hours with a speed of 0.25°C/h to a target temperature of 36.5°C (± 0.3°C). Receives: Procedure: Mild therapeutic hypothermia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial Salvage Index (MSI)
Myocardial Salvage Index (MSI) is measured by 99mTc-sestamibi single photon emission tomography at day 3 (± 1 day) post-percutaneous coronary intervention, calculated as MSI = (area at risk-final infarct size)/area at risk, where area at risk is the area at risk and final infarct size is the final infarct size.
Measured: 3 day (± 1 day) post-percutaneous coronary intervention
Secondary outcomes (14)
Area under the curve of serum creatine kinase-MB within 72 hours post-percutaneous coronary intervention
Measured: 72 hours post-percutaneous coronary intervention
Area under the curve of serum cardiac troponin I within 72 hours post-percutaneous coronary intervention
Measured: 72 hours post-percutaneous coronary intervention
Cardiac function
Echocardiographic indicators, including left ventricular ejection fraction, cardiac index, left ventricular end-systolic volume index, left ventricular end-diastolic volume index, the ratio of early diastolic filling velocity to atrial systolic filling velocity, maximum rate of left ventricular pressure rise/decline, measured every 24 hours post-percutaneous coronary intervention
Measured: Baseline, and every 24 hours post-percutaneous coronary intervention up to discharge.
Serum N-terminal pro-B-type natriuretic peptide levels
Serum N-terminal pro-B-type natriuretic peptide measured every 4 hours post-percutaneous coronary intervention
Measured: Baseline, and every 4 hours post-percutaneous coronary intervention up to discharge.
Arterial blood lactate levels
Arterial blood lactate levels measured every 4 hours post-percutaneous coronary intervention
Measured: Baseline, and every 4 hours post-percutaneous coronary intervention up to discharge.
Major adverse cardiovascular events
Major adverse cardiovascular events are defined as cardiovascular death, recurrent myocardial infarction, stroke, recurrent shock, urgent or unplanned coronary revascularization, re-hospitalization for heart failure, severe mechanical complications, Bleeding Academic Research Consortium ≥ Grade 3 bleeding, need for renal replacement therapy due to acute kidney injury.
Measured: 24 hours, 7 days, 30 days post-percutaneous coronary intervention, and during hospitalization
Rates of successful extracorporeal membrane oxygenation weaning
Successful weaning from extracorporeal membrane oxygenation is defined as survival for more than 24 hours after discontinuation without the need for mechanical circulatory support.
Measured: Wean off extracorporeal membrane oxygenation after 24 hours
Rates of heart transplantation, or implantation of left ventricular assist device through study completion
Measured: At discharge
Mortality
All-cause and cardiac-cause mortality
Measured: 24 hours, 7 days, and 30 days post-percutaneous coronary intervention, and during hospitalization
Extracorporeal membrane oxygenation-related complications
Extracorporeal membrane oxygenation-related complications included Bleeding Academic Research Consortium ≥ Grade 3 bleeding, thrombosis, thrombocytopenia, stroke, limb ischemia, infection.
Measured: Up to ECMO weaning
Mild therapeutic hypothermia-associated safety events
Mild therapeutic hypothermia-associated safety events included Bleeding Academic Research Consortium ≥ Grade 3 bleeding, infection, hypothermia injury, and transfusion, etc.
Measured: 24 hours, 7 days, and 30 days post-PCI, and during hospitalization
Mean arterial pressure, and heart rate
Measured: Baseline, and every 4 hours post-percutaneous coronary intervention up to discharge.
Blood routine examination
Blood routine examination included red blood cell (RBC) count, hemoglobin, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, red cell distribution width, white blood cell (WBC) count, platelet count, mean platelet volume, platelet distribution width, platelet crit.
Measured: Baseline, and every 4 hours post-percutaneous coronary intervention up to discharge.
Coagulation function monitoring
Coagulation function monitoring included prothrombin time, activated partial thromboplastin time, thrombin time, fibrinogen, D-Dimer.
Measured: Baseline, and every 4 hours post-percutaneous coronary intervention up to discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study startSep 2025 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial Infarction Complicated With Cardiogenic ShockStudies of the same condition, open and under way.
- More trials run by Beijing Anzhen HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chenglong Li, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07186972
- Sponsor's protocol ID
- 2025AZB6019
- Acronym
- HOPE-CS
- Status last verified
- Sep 2025
- First submitted
- 9 Sep 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Mild Therapeutic Hypothermia in Percutaneous Coronary Intervention Under Venous-arterial Extracorporeal Membrane Oxygenation for Acute Myocardial Infarction Complicated With Cardiogenic Shock
- ClinicalTrials.gov ID
- NCT07186972
- Acronym / sponsor ID
- HOPE-CS / 2025AZB6019
- Conditions
- Acute Myocardial Infarction Complicated With Cardiogenic Shock, Mild Therapeutic Hypothermia, Venous-arterial Extracorporeal Membrane Oxygenation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 22 Sep 2025 (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.
This study is a randomized controlled trial conducted at Beijing Anzhen Hospital, Capital Medical University. The primary objective is to assess the efficacy of mild therapeutic hypothermia in reducing infarct size and improving cardiac function in patients receiving percutaneous coronary intervention under venous-arterial extracorporeal membrane oxygenation for acute myocardial infarction complicated with cardiogenic shock. Secondary objectives include evaluating the safety of mild therapeutic hypothermia and its impact on venous-arterial extracorporeal membrane oxygenation weaning success and short-term survival.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Maintaining a target temperature of 36.5℃ (±0.3℃) during percutaneous coronary intervention |
| Mild therapeutic hypothermia | Experimental | Procedure: Mild therapeutic hypothermiaCooling down to a target temperature of 33.0°C-34.0°C before percutaneous coronary intervention, and then rewarming was initiated after 24 hours with a speed of 0.25°C/h to a target temperature of 36.5°C (± 0.3°C). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with acute myocardial infarction complicated by cardiogenic shock who undergo emergency percutaneous coronary intervention under venoarterial extracorporeal membrane oxygenation support and endotracheal intubation.
- Patients diagnosed with anterior wall myocardial infarction.
- Aged ≥18 years.
Key exclusion criteria (10 listed)
- Cardiogenic shock lasting more than 12 hours or a history of chronic congestive heart failure.
- History of prior coronary artery intervention, coronary artery bypass grafting, heart transplantation, heart-lung transplantation, or left ventricular assist device implantation.
- Cardiogenic shock associated with mechanical complications of acute myocardial infarction, such as ventricular septal rupture, acute mitral regurgitation, acute ventricular septal defect, and cardiac tamponade.
- Refractory out-of-hospital cardiac arrest or cardiopulmonary resuscitation lasting longer than 45 minutes.
- Known end-stage renal disease (e.g., on dialysis or post-kidney transplantation) or severe liver failure (e.g., cirrhosis or acute hepatitis).
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 |
|---|---|---|
| Mild therapeutic hypothermiaBefore percutaneous coronary intervention, cooling was maintained with venous-arterial extracorporeal membrane oxygenation in patients receiving mild therapeutic hypothermia. By protocol, cooling down to the target temperature of 33°C-34°C was set at the maximum possible cooling rate. After the target temperature was reached, it was maintained for 24 hours with the temperature regulation function of the extracorporeal membrane oxygenation system by central temperature measurement in the urinary bladder. After 24 hours, rewarming was initiated with a speed of 0.25°C/h to a target temperature of 36.5℃ (± 0.3℃). To avoid shivering in the mild therapeutic hypothermia group, the patients were treated with a protocol including deep sedation and optional muscle relaxation. | Procedure or surgery | Mild therapeutic hypothermia |
Primary outcome
Myocardial Salvage Index (MSI)
Time frame: 3 day (± 1 day) post-percutaneous coronary intervention
Myocardial Salvage Index (MSI) is measured by 99mTc-sestamibi single photon emission tomography at day 3 (± 1 day) post-percutaneous coronary intervention, calculated as MSI = (area at risk-final infarct size)/area at risk, where area at risk is the area at risk and final infarct size is the final infarct size.
14 secondary outcomes
Area under the curve of serum creatine kinase-MB within 72 hours post-percutaneous coronary intervention
Time frame: 72 hours post-percutaneous coronary intervention
Area under the curve of serum cardiac troponin I within 72 hours post-percutaneous coronary intervention
Time frame: 72 hours post-percutaneous coronary intervention
Cardiac function
Time frame: Baseline, and every 24 hours post-percutaneous coronary intervention up to discharge.
Serum N-terminal pro-B-type natriuretic peptide levels
Time frame: Baseline, and every 4 hours post-percutaneous coronary intervention up to discharge.
Arterial blood lactate levels
Time frame: Baseline, and every 4 hours post-percutaneous coronary intervention up to discharge.
Major adverse cardiovascular events
Time frame: 24 hours, 7 days, 30 days post-percutaneous coronary intervention, and during hospitalization
Rates of successful extracorporeal membrane oxygenation weaning
Time frame: Wean off extracorporeal membrane oxygenation after 24 hours
Rates of heart transplantation, or implantation of left ventricular assist device through study completion
Time frame: At discharge
Mortality
Time frame: 24 hours, 7 days, and 30 days post-percutaneous coronary intervention, and during hospitalization
Extracorporeal membrane oxygenation-related complications
Time frame: Up to ECMO weaning
Mild therapeutic hypothermia-associated safety events
Time frame: 24 hours, 7 days, and 30 days post-PCI, and during hospitalization
Mean arterial pressure, and heart rate
Time frame: Baseline, and every 4 hours post-percutaneous coronary intervention up to discharge.
Blood routine examination
Time frame: Baseline, and every 4 hours post-percutaneous coronary intervention up to discharge.
Coagulation function monitoring
Time frame: Baseline, and every 4 hours post-percutaneous coronary intervention up to discharge.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
Related trials for Acute Myocardial Infarction Complicated With Cardiogenic Shock
RecruitingObservational study
Assessment of Support With Impella® Best Practices in Acute Myocardial Infarction Complicated by Cardiogenic Shock
AMI Cardiogenic Shock
Recruiting
Efferon CT Hemoadsorption for Cardiogenic Shock in Acute Myocardial Infarction
Myocardial Infarction, Cardiogenic Shock
Not yet recruitingObservational study
Multidisciplinary Collaborative Care System for Acute Myocardial Infarction Complicated With Cardiogenic Shock
Acute Myocardial Infarction Complicated With Cardiogenic Shock
Not yet recruiting
CorVad Myocardial Infarction Complicated with Cardiogenic Shock Trial
Cardiogenic Shock
RecruitingPhase 4
Revascularization Strategy of Multivessel Disease for Patients with Acute Myocardial Infarction Complicated by Cardiogenic Shock Undergoing Veno-arterial Extracorporeal Membrane Oxygenator
Cardiogenic Shock, Acute Myocardial Infarction
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Mild therapeutic hypothermia in people with Acute Myocardial Infarction Complicated With Cardiogenic Shock and Mild Therapeutic Hypothermia, run by Beijing Anzhen Hospital.
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 3 inclusion and 10 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: opening soon, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Myocardial Salvage Index (MSI) (time frame: 3 day (± 1 day) post-percutaneous coronary intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Sep 2025.