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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
44
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.
Myocardial Salvage Index (MSI)
Myocardial Salvage Index (MSI) is measured by 99mTc-sestamibi single photon emission tomography at day 3 (± 1 day) post-percutaneous coronary intervention, calculated as MSI = (area at risk-final infarct size)/area at risk, where area at risk is the area at risk and final infarct size is the final infarct size.
Time frame: 3 day (± 1 day) post-percutaneous coronary intervention
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
Echocardiographic indicators, including left ventricular ejection fraction, cardiac index, left ventricular end-systolic volume index, left ventricular end-diastolic volume index, the ratio of early diastolic filling velocity to atrial systolic filling velocity, maximum rate of left ventricular pressure rise/decline, measured every 24 hours post-percutaneous coronary intervention
Time frame: Baseline, and every 24 hours post-percutaneous coronary intervention up to discharge.
Serum N-terminal pro-B-type natriuretic peptide levels
Serum N-terminal pro-B-type natriuretic peptide measured every 4 hours post-percutaneous coronary intervention
Time frame: Baseline, and every 4 hours post-percutaneous coronary intervention up to discharge.
Arterial blood lactate levels
Arterial blood lactate levels measured every 4 hours post-percutaneous coronary intervention
Time frame: Baseline, and every 4 hours post-percutaneous coronary intervention up to discharge.
Major adverse cardiovascular events
Major adverse cardiovascular events are defined as cardiovascular death, recurrent myocardial infarction, stroke, recurrent shock, urgent or unplanned coronary revascularization, re-hospitalization for heart failure, severe mechanical complications, Bleeding Academic Research Consortium ≥ Grade 3 bleeding, need for renal replacement therapy due to acute kidney injury.
Time frame: 24 hours, 7 days, 30 days post-percutaneous coronary intervention, and during hospitalization
Rates of successful extracorporeal membrane oxygenation weaning
Successful weaning from extracorporeal membrane oxygenation is defined as survival for more than 24 hours after discontinuation without the need for mechanical circulatory support.
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
All-cause and cardiac-cause mortality
Time frame: 24 hours, 7 days, and 30 days post-percutaneous coronary intervention, and during hospitalization
Extracorporeal membrane oxygenation-related complications
Extracorporeal membrane oxygenation-related complications included Bleeding Academic Research Consortium ≥ Grade 3 bleeding, thrombosis, thrombocytopenia, stroke, limb ischemia, infection.
Time frame: Up to ECMO weaning
Mild therapeutic hypothermia-associated safety events
Mild therapeutic hypothermia-associated safety events included Bleeding Academic Research Consortium ≥ Grade 3 bleeding, infection, hypothermia injury, and transfusion, etc.
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.
Blood routine examination
Blood routine examination included red blood cell (RBC) count, hemoglobin, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, red cell distribution width, white blood cell (WBC) count, platelet count, mean platelet volume, platelet distribution width, platelet crit.
Time frame: Baseline, and every 4 hours post-percutaneous coronary intervention up to discharge.
Coagulation function monitoring
Coagulation function monitoring included prothrombin time, activated partial thromboplastin time, thrombin time, fibrinogen, D-Dimer.
Time frame: Baseline, and every 4 hours post-percutaneous coronary intervention up to discharge.
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