This study aim to investigate the myocardium protection effect of cardiomyopeptidin in patients undergoing primary PCI for ST-elevation myocardial infarction through myocardial enhanced MRI.
Investigators will enroll 160 patients with STEMI who were admitted to the Chinese PLA General Hospital between March 2022 and Marchr 2024,the investigators randomly assign eligible patients in a 1:1 ratio to either cardiomyopeptidin intervention group or control group befor primary PCI. The cardiomyopeptidin intervention group patients received intravenous infusion 3 mg/(kg·d) of cardiomyopeptidin during the PCI until 3 days after operation. Primary end point of the study was the area of infarct size measured by cardiac magnetic resonance (CMR). and secondary endpoints include slow flow/no-reflow incidence, corrected TIMI frame count (cTFC), ST-segment fall rate of ECG, cardiac enzymes and troponin, area of myocardial edema, microvascular obstruction, left ventricular ejection fraction, and composite cardiovascular events during the study period: all-cause death, cardiovascular death, unplanned hospitalization for heart failure, and revascularization. All adverse clinical events as well as study end points were monitored and adjudicated by the independent event committee.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
160
cardiomyopeptidin intervention group will accept cardiomyopeptidin (Dalian Zhenao Pharmaceutical Co., Ltd., approval number: National Drug Approval No. H20052173, specification: 20 mg/tube) 3 mg/(kg·d);
Chinese People's Liberation Army General Hospital
Beijing, Beijing Municipality, China
Myocardial infarct size according to MR delayed enhancement scan
Two experienced MRI cardiologists analyzed the delayed enhancement image
Time frame: 7 days after PCI
MACEs
MACEs concluding all-cause death, cardiovascular death, unplanned hospitalization for heart failure, and revascularization
Time frame: follow up in six months
myocardial edema area
Two experienced MRI cardiologists analyzed the delayed enhancement image
Time frame: 7 days after PCI
microvascular obstruction and left ventricular ejection fraction
Two experienced MRI cardiologists analyzed the delayed enhancement image
Time frame: 7 days after PCI
incidence of slow flow/no-reflow
Angiographic slow/no-reflow during PCI was defined as thrombolysis in myocardial infarction (TIMI) flow grade ≤ 2 during the procedure without evidence of dissection
Time frame: Immediately after PCI
corrected thrombolysis in myocardial infarction (TIMI) frame count (cTFC);
The cTFC was measured by two cardiologists, and the average value was taken. When scanning at a rate of 15 frames per second, cTFC \> 20 frames per second was used as the criterion for the diagnosis of slow blood flow after primary PCI.
Time frame: Immediately after PCI
ST-segment fall rate of electrocardiogram (ECG)
Time frame: 6 hours, 12 hours, 24 hours after myocardial infarction
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