Cardiovascular Diseases
Conditions
Brief summary
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
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.
Interventions
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)；
Sponsors
Dalian Zhen-Ao Bio-Tech Co., Ltd.
Chinese PLA General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Myocardial infarct size according to MR delayed enhancement scan | 7 days after PCI | Two experienced MRI cardiologists analyzed the delayed enhancement image |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| myocardial edema area | 7 days after PCI | Two experienced MRI cardiologists analyzed the delayed enhancement image |
| microvascular obstruction and left ventricular ejection fraction | 7 days after PCI | Two experienced MRI cardiologists analyzed the delayed enhancement image |
| MACEs | follow up in six months | MACEs concluding all-cause death, cardiovascular death, unplanned hospitalization for heart failure, and revascularization |
| corrected thrombolysis in myocardial infarction (TIMI) frame count (cTFC); | Immediately after PCI | 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. |
| ST-segment fall rate of electrocardiogram (ECG) | 6 hours, 12 hours, 24 hours after myocardial infarction | — |
| incidence of slow flow/no-reflow | Immediately after PCI | Angiographic slow/no-reflow during PCI was defined as thrombolysis in myocardial infarction (TIMI) flow grade ≤ 2 during the procedure without evidence of dissection |
Countries
China
Outcome results
None listed