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

NCT ID: NCT06117046

Last Updated: 2025-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

234 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-27

Study Completion Date

2023-11-25

Brief Summary

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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.

Detailed Description

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Conditions

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Myocardial Injury ICU

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Cardiopeptidin

Cardiopeptidin was administered intravenously once a day with 60mg of cardiopeptide for 3 days

Group Type EXPERIMENTAL

Cardiopeptidin

Intervention Type 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

50 ml of normal saline intravenous infusion.

Group Type PLACEBO_COMPARATOR

50 ml of normal saline intravenous infusion

Intervention Type DRUG

50 ml of normal saline intravenous infusion

Interventions

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Cardiopeptidin

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.

Intervention Type DRUG

50 ml of normal saline intravenous infusion

50 ml of normal saline intravenous infusion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Patients who are expected to die within 48 hours of ICU admission
2. 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
3. cardiopulmonary resuscitation and/or electrical defibrillation before admission
4. patients with acute ischemic stroke
5. patients with stage 5 chronic kidney disease
6. during pregnancy or breastfeeding
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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zhenhua zeng

Role: PRINCIPAL_INVESTIGATOR

Nanfang Hospital, Southern Medical University

Locations

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Southern medical university Nanfang hospital

Guangzhou, , China

Site Status

Countries

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China

Other Identifiers

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NFEC-2023-060

Identifier Type: -

Identifier Source: org_study_id

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