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NCT Number: NCT07186972

Evaluation of MTH in PCI Under VA-ECMO for AMICS

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.

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Key information

Conditions

Acute Myocardial Infarction Complicated With Cardiogenic Shock Mild Therapeutic Hypothermia Venous-arterial Extracorporeal Membrane Oxygenation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).
  • 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.

Treatment and study plan

Mild therapeutic hypothermia

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Area under the curve of serum creatine kinase-MB within 72 hours post-percutaneous coronary intervention

    Time frame: 72 hours post-percutaneous coronary intervention

  2. Area under the curve of serum cardiac troponin I within 72 hours post-percutaneous coronary intervention

    Time frame: 72 hours post-percutaneous coronary intervention

  3. Cardiac function

    Time frame: Baseline, and every 24 hours post-percutaneous coronary intervention up to discharge.

    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

  4. Serum N-terminal pro-B-type natriuretic peptide levels

    Time frame: Baseline, and every 4 hours post-percutaneous coronary intervention up to discharge.

    Serum N-terminal pro-B-type natriuretic peptide measured every 4 hours post-percutaneous coronary intervention

  5. Arterial blood lactate levels

    Time frame: Baseline, and every 4 hours post-percutaneous coronary intervention up to discharge.

    Arterial blood lactate levels measured every 4 hours post-percutaneous coronary intervention

  6. Major adverse cardiovascular events

    Time frame: 24 hours, 7 days, 30 days post-percutaneous coronary intervention, and during hospitalization

    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.

  7. Rates of successful extracorporeal membrane oxygenation weaning

    Time frame: Wean off extracorporeal membrane oxygenation after 24 hours

    Successful weaning from extracorporeal membrane oxygenation is defined as survival for more than 24 hours after discontinuation without the need for mechanical circulatory support.

  8. Rates of heart transplantation, or implantation of left ventricular assist device through study completion

    Time frame: At discharge

  9. Mortality

    Time frame: 24 hours, 7 days, and 30 days post-percutaneous coronary intervention, and during hospitalization

    All-cause and cardiac-cause mortality

  10. Extracorporeal membrane oxygenation-related complications

    Time frame: Up to ECMO weaning

    Extracorporeal membrane oxygenation-related complications included Bleeding Academic Research Consortium ≥ Grade 3 bleeding, thrombosis, thrombocytopenia, stroke, limb ischemia, infection.

  11. Mild therapeutic hypothermia-associated safety events

    Time frame: 24 hours, 7 days, and 30 days post-PCI, and during hospitalization

    Mild therapeutic hypothermia-associated safety events included Bleeding Academic Research Consortium ≥ Grade 3 bleeding, infection, hypothermia injury, and transfusion, etc.

  12. Mean arterial pressure, and heart rate

    Time frame: Baseline, and every 4 hours post-percutaneous coronary intervention up to discharge.

  13. Blood routine examination

    Time frame: Baseline, and every 4 hours post-percutaneous coronary intervention up to discharge.

    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.

  14. Coagulation function monitoring

    Time frame: Baseline, and every 4 hours post-percutaneous coronary intervention up to discharge.

    Coagulation function monitoring included prothrombin time, activated partial thromboplastin time, thrombin time, fibrinogen, D-Dimer.

Sponsors and collaborators

Lead sponsor

Beijing Anzhen Hospital

Other

Registry information

Official study title

Evaluation of Mild Therapeutic Hypothermia in Percutaneous Coronary Intervention Under Venous-arterial Extracorporeal Membrane Oxygenation for Acute Myocardial Infarction Complicated With Cardiogenic Shock

Acronym: HOPE-CS

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Sep 22, 2025
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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