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

Phase 4

Completed

• Conditions: Cardiovascular Diseases
• Interventions: Drug: cardiomyopeptidin

• Registration Number: NCT06155110
• Lead Sponsor: Chinese PLA General Hospital

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.

Study Timeline

• Study Start: 2019-11-01
• Status Verified: 2023-11
• Study First Submitted: 2023-11-25
• Study First Submitted QC: 2023-12-01
• Study First Posted: 2023-12-04
• Primary Completion: 2025-03-01
• Study Completion: 2025-05-01
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cardiomyopeptidin group	cardiomyopeptidin	The Cardiomyopeptidin group received intravenous infusion 3 mg/(kg·d) of cardiomyopeptidin during the PCI until 3 days after operation

Primary Outcome Measures

Name	Time	Method
Myocardial infarct size according to MR delayed enhancement scan	7 days after PCI	Two experienced MRI cardiologists analyzed the delayed enhancement image

Secondary Outcome Measures

Name	Time	Method
myocardial edema area	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
microvascular obstruction and left ventricular ejection fraction	7 days after PCI	Two experienced MRI cardiologists analyzed the delayed enhancement image
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
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

Trial Locations

Locations (1)

Chinese People's Liberation Army General Hospital; 🇨🇳 Peking, Beijing, China