A Randomized, Single-blind, Controlled Clinical Study of Cardiomyopeptidin on Improving Ischemia-reperfusion Injury in Patients With Acute ST-segment Elevation Myocardial Infarction After Primary PCI

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Chinese People's Liberation Army General Hospital

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Drug: cardiomyopeptidin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: STEMI patients: typical chest pain lasting 30 min within the previous 12 h, a clear ST-segment elevation of N0.1 mV in ≥2 contiguous electrocardiographic leads, and elevated blood levels of troponin T patients were scheduled to undergo diagnostic cardiac angiography or percutaneous coronary interventions Exclusion Criteria: had once treated by ivabradine history of myocardial infarction mechanical complications Unable to perform myocardial MRI liver and kidney failure malignant tumor unconscious Patients with other significant abnormal signs, laboratory tests and clinical disease are unsuitable for participation in the study accessed by clinicians.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cardiomyopeptidin group<br>The Cardiomyopeptidin group received intravenous infusion 3 mg/(kg·d) of cardiomyopeptidin during the PCI until 3 days after operation | Drug: cardiomyopeptidin<br>* 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)；<br>|
| No Intervention: The control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial infarct size according to MR delayed enhancement scan | Two experienced MRI cardiologists analyzed the delayed enhancement image | 7 days after PCI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACEs | MACEs concluding all-cause death, cardiovascular death, unplanned hospitalization for heart failure, and revascularization | follow up in six months | 
| myocardial edema area | Two experienced MRI cardiologists analyzed the delayed enhancement image | 7 days after PCI | 
| microvascular obstruction and left ventricular ejection fraction | Two experienced MRI cardiologists analyzed the delayed enhancement image | 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 | 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. | Immediately after PCI | 
| ST-segment fall rate of electrocardiogram (ECG) |  | 6 hours, 12 hours, 24 hours after myocardial infarction |