Chinese People's Liberation Army General Hospital
Beijing, Beijing Municipality, 100853, China
NCT Number: NCT06155110
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.
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Notify Me18 year–80 year
All sexes
Interventional
Phase 4
Beijing, Beijing Municipality, 100853, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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);
Time frame: 7 days after PCI
Two experienced MRI cardiologists analyzed the delayed enhancement image
Time frame: follow up in six months
MACEs concluding all-cause death, cardiovascular death, unplanned hospitalization for heart failure, and revascularization
Time frame: 7 days after PCI
Two experienced MRI cardiologists analyzed the delayed enhancement image
Time frame: 7 days after PCI
Two experienced MRI cardiologists analyzed the delayed enhancement image
Time frame: 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
Time frame: 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.
Time frame: 6 hours, 12 hours, 24 hours after myocardial infarction
Chinese PLA General Hospital
Other
Chinese People's Liberation Army General Hospital
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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