Clinical trial 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Myocardial Injury
ICU
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2023-11-03
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: major adverse cardiac events
timeFrame: On the day of enrollment, until 28 days.
Secondary outcomes:
measure: 28-day all-cause mortality
timeFrame: 28-day
measure: 90-day all-cause mortality
timeFrame: 90-day
measure: Cardiac adverse events
timeFrame: In hospital, until the patient is discharged.
measure: LVEF
timeFrame: On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
measure: APACHE II
timeFrame: On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
measure: Hypersensitive troponin T
timeFrame: On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
measure: MB
timeFrame: On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
measure: NT-Pro BNP
timeFrame: On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
measure: LDH
timeFrame: On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
measure: α-HBDH
timeFrame: On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
measure: CK
timeFrame: On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
measure: CKMB
timeFrame: On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
measure: Lac
timeFrame: On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Southern medical university Nanfang hospital
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: zhenhua zeng
role: PRINCIPAL_INVESTIGATOR
References: