Clinical trial
Cardioprotective Effects of Cardiopeptides for Injection in Patients With Non-severe Cardiac Disease: a Single-center Randomized Controlled Trial
Name
NFEC-2023-060
Description
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.
Trial arms
Trial start
2023-02-27
Estimated PCD
2023-11-25
Trial end
2023-11-25
Status
Recruiting
Phase
Early phase I
Treatment
Cardiopeptides
Cardiopeptide was administered intravenously once a day with 60mg of cardiopeptide for 3 days
Arms:
Cardiopeptides
Size
234
Primary endpoint
Hypersensitive troponin T
On the day of enrollment, 1/3/6/13 days after enrollment，up to two weeks
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 234, 'type': 'ESTIMATED'}}
Updated at
2023-11-03
1 organization
1 product
2 indications
Organization
Nanfang Hospital, Southern Medical UniversityProduct
CardiopeptidesIndication
Myocardial InjuryIndication
Intensive Care Unit (ICU)