Evaluation of MTH in PCI Under VA-ECMO for AMICS (HOPE-CS)

Capital Medical University

Status: Not yet enrolling

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

Treatments: Procedure: Mild therapeutic hypothermia

Study type: Interventional

Funder types: Other

Identifiers

NCT07186972

2025AZB6019

Details and patient eligibility

About

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.

Enrollment: 44 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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.
2. Patients diagnosed with anterior wall myocardial infarction.
3. Aged ≥18 years.

Exclusion criteria

1. Cardiogenic shock lasting more than 12 hours or a history of chronic congestive heart failure.
2. History of prior coronary artery intervention, coronary artery bypass grafting, heart transplantation, heart-lung transplantation, or left ventricular assist device implantation.
3. 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.
4. Refractory out-of-hospital cardiac arrest or cardiopulmonary resuscitation lasting longer than 45 minutes.
5. Known end-stage renal disease (e.g., on dialysis or post-kidney transplantation) or severe liver failure (e.g., cirrhosis or acute hepatitis).
6. Contraindications to hypothermia therapy, such as cryoglobulinemia, sickle cell disease, cold agglutinin disease, and vasospastic disorders (e.g., Raynaud's disease and thromboangiitis obliterans).
7. 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.
8. Pregnency.
9. Currently participation in other interventional clinical trials.
10. Refusal to sign informed consent related to this trial.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Control

No Intervention group

Description:

Maintaining a target temperature of 36.5℃ (±0.3℃) during percutaneous coronary intervention

Mild therapeutic hypothermia

Experimental group

Description:

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).

Treatment:

Procedure: Mild therapeutic hypothermia