NCT07186972

Evaluation of MTH in PCI Under VA-ECMO for AMICS

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Beijing Anzhen Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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 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.

Timeline

• Start date: 2025-09-01
• Primary completion: 2028-05-01
• Completion: 2028-05-01
• First posted: 2025-09-22
• Last updated: 2025-09-22