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Completed

NCT Number: NCT06117046

The Cardio-protective Effect of Cardiomyopeptidin on Myocardial Injury in ICU Patients With Non-organic Heart Disease: a Prospective, Single-blind, Randomized Controlled Pilot Study

The study was a single-center, randomized controlled pilot study. To explore the cardioprotective effect of cardiopeptidin on non-heart disease patients with severe cardiac injury by comparing whether cardiopeptidin was used.

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Key information

Conditions

Myocardial Injury ICU

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Southern medical university Nanfang hospital

Guangzhou, 510515, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥18 years old
  • The high-sensitive troponin T index was higher than the normal value during ICU hospitalization
  • Obtain the informed consent of the subject or legal agent

Exclusion criteria

  • Patients who are expected to die within 48 hours of ICU admission
  • previous diagnosis of acute coronary syndrome, chronic cardiomyopathy, pulmonary heart disease, acute myocarditis, pericardial tamponade and other diseases that have been confirmed to cause myocardial injury
  • cardiopulmonary resuscitation and/or electrical defibrillation before admission
  • patients with acute ischemic stroke
  • patients with stage 5 chronic kidney disease
  • during pregnancy or breastfeeding

Treatment and study plan

Cardiopeptidin

Drug

Cardiopeptidin was administered intravenously once a day with cardiopeptidin for 3 days.The dosing regimen follows the recommended dosage of 1 mg/kg/day as outlined in the product manual, with doses calculated based on the ideal body weight.

50 ml of normal saline intravenous infusion

Drug

50 ml of normal saline intravenous infusion

Primary outcomes

  1. major adverse cardiac events

    Time frame: On the day of enrollment, until 28 days.

    major adverse cardiac events

Secondary outcomes

  1. 28-day all-cause mortality

    Time frame: 28-day

    28-day all-cause mortality

  2. 90-day all-cause mortality

    Time frame: 90-day

    90-day all-cause mortality

  3. Cardiac adverse events

    Time frame: In hospital, until the patient is discharged.

    Cardiac adverse events

  4. LVEF

    Time frame: On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks

    LVEF

  5. APACHE II

    Time frame: On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks

    APACHE II

  6. Hypersensitive troponin T

    Time frame: On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks

    On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks

  7. MB

    Time frame: On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks

    MB

  8. NT-Pro BNP

    Time frame: On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks

    NT-Pro BNP

  9. LDH

    Time frame: On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks

    LDH

  10. α-HBDH

    Time frame: On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks

    α-HBDH

  11. CK

    Time frame: On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks

    CK

  12. CKMB

    Time frame: On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks

    CKMB

  13. Lac

    Time frame: On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks

    Lac

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Nov 3, 2023
Registry last updated
Feb 13, 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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