Evaluation of MTH in PCI Under VA-ECMO for AMICS

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

Overview

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.

Interventions

• Procedure Mild therapeutic hypothermia
  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

Primary outcome measures

• Myocardial Salvage Index (MSI) [Time frame: 3 day (± 1 day) post-percutaneous coronary intervention]

Secondary outcome measures (12)

• 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.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07186972 · 2025AZB6019

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗