Status:
NOT_YET_RECRUITING
Evaluation of MTH in PCI Under VA-ECMO for AMICS
Lead Sponsor:
Beijing Anzhen Hospital
Conditions:
Acute Myocardial Infarction Complicated With Cardiogenic Shock
Mild Therapeutic Hypothermia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 reducin...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2028
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT07186972
Start Date
September 1 2025
End Date
May 1 2028
Last Update
September 22 2025
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