Cardioprotective Effects of Cardiopeptides for Injection in Patients With Non-severe Cardiac Disease: a Single-center Randomized Controlled Trial

Myocardial Injury Clinical Trial

Official title:

Cardioprotective Effects of Cardiopeptides for Injection in Patients With Non-severe Cardiac Disease: a Single-center Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06117046
• Other study ID #: NFEC-2023-060
• Status: Recruiting
• Phase: Phase 4
• Start date: February 27, 2023
• Est. completion date: November 25, 2023

Study information

• Verified date: October 2023
• Source: Nanfang Hospital, Southern Medical University
• Contact: Hongbin Hu
• Phone: +8613922483752
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 234
• Est. completion date: November 25, 2023
• Est. primary completion date: November 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Diseases
• ICU
• Myocardial Injury

Intervention

Drug:
• Cardiopeptides
Cardiopeptide was administered intravenously once a day with 60mg of cardiopeptide for 3 days

Locations

Country	Name	City	State
China	Southern medical university Nanfang hospital	Guangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital, Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypersensitive troponin T	Hypersensitive troponin T	On the day of enrollment, 1/3/6/13 days after enrollment,up to two weeks
Secondary	Cardiac adverse events	Cardiac adverse events	In hospital, until the patient is discharged.