Not Yet RecruitingNot Applicable

Evaluation of MTH in PCI Under VA-ECMO for AMICS

44 participantsStarted 2025-09

Plain-language 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 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.

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

Myocardial Salvage Index (MSI)

Timeframe: 3 day (± 1 day) post-percutaneous coronary intervention

Trial details

NCT IDNCT07186972

SponsorBeijing Anzhen Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-05

View on ClinicalTrials.gov More Acute Myocardial Infarction Complicated With Cardiogenic Shock trials