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

Phase 4

Completed

• Conditions: Myocardial Injury; ICU
• Interventions: Drug: Cardiopeptidin; Drug: 50 ml of normal saline intravenous infusion

• Registration Number: NCT06117046
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief Summary

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

Not available

Study Timeline

• Study Start: 2023-02-27
• Study First Submitted: 2023-09-14
• Study First Submitted QC: 2023-10-31
• Study First Posted: 2023-11-03
• Primary Completion: 2023-11-25
• Study Completion: 2023-11-25
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 234

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cardiopeptidin	Cardiopeptidin	Cardiopeptidin was administered intravenously once a day with 60mg of cardiopeptide for 3 days
50 ml of normal saline intravenous infusion	50 ml of normal saline intravenous infusion	50 ml of normal saline intravenous infusion.

Primary Outcome Measures

Name	Time	Method
major adverse cardiac events	On the day of enrollment, until 28 days.	major adverse cardiac events

Secondary Outcome Measures

Name	Time	Method
28-day all-cause mortality	28-day	28-day all-cause mortality
90-day all-cause mortality	90-day	90-day all-cause mortality
Cardiac adverse events	In hospital, until the patient is discharged.	Cardiac adverse events
LVEF	On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks	LVEF
APACHE II	On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks	APACHE II
Hypersensitive troponin T	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
MB	On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks	MB
NT-Pro BNP	On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks	NT-Pro BNP
LDH	On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks	LDH
α-HBDH	On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks	α-HBDH
CK	On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks	CK
CKMB	On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks	CKMB
Lac	On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks	Lac

Trial Locations

Locations (1)

Southern medical university Nanfang hospital; 🇨🇳 Guangzhou, China