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NCT Number: NCT06155110

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

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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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Chinese People's Liberation Army General Hospital

Beijing, Beijing Municipality, 100853, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

cardiomyopeptidin

Drug

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);

Primary outcomes

  1. Myocardial infarct size according to MR delayed enhancement scan

    Time frame: 7 days after PCI

    Two experienced MRI cardiologists analyzed the delayed enhancement image

Secondary outcomes

  1. MACEs

    Time frame: follow up in six months

    MACEs concluding all-cause death, cardiovascular death, unplanned hospitalization for heart failure, and revascularization

  2. myocardial edema area

    Time frame: 7 days after PCI

    Two experienced MRI cardiologists analyzed the delayed enhancement image

  3. microvascular obstruction and left ventricular ejection fraction

    Time frame: 7 days after PCI

    Two experienced MRI cardiologists analyzed the delayed enhancement image

  4. incidence of slow flow/no-reflow

    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

  5. corrected thrombolysis in myocardial infarction (TIMI) frame count (cTFC);

    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.

  6. ST-segment fall rate of electrocardiogram (ECG)

    Time frame: 6 hours, 12 hours, 24 hours after myocardial infarction

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Collaborators

  • Dalian Zhen-Ao Bio-Tech Co., Ltd.

Registry information

Official study title

Chinese People's Liberation Army General Hospital

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Dec 4, 2023
Registry last updated
May 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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