A Randomized, Single-blind, Controlled Clinical Study of Cardiomyopeptidin on Improving Ischemia-reperfusion Injury in Patients With Acute ST-segment Elevation Myocardial Infarction After Primary PCI

Chinese People's Liberation Army General Hospital

This study aim to investigate the myocardium protection effect of cardiomyopeptidin in patients undergoing primary PCI for ST-elevation myocardial infarction through myocardial enhanced MRI.

Study Overview

• Status: Active, not recruiting
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Drug: cardiomyopeptidin

Detailed Description

Investigators will enroll 160 patients with STEMI who were admitted to the Chinese PLA General Hospital between March 2022 and Marchr 2024，the investigators randomly assign eligible patients in a 1:1 ratio to either cardiomyopeptidin intervention group or control group befor primary PCI. The cardiomyopeptidin intervention group patients received intravenous infusion 3 mg/(kg·d) of cardiomyopeptidin during the PCI until 3 days after operation. Primary end point of the study was the area of infarct size measured by cardiac magnetic resonance (CMR). and secondary endpoints include slow flow/no-reflow incidence, corrected TIMI frame count (cTFC), ST-segment fall rate of ECG, cardiac enzymes and troponin, area of myocardial edema, microvascular obstruction, left ventricular ejection fraction, and composite cardiovascular events during the study period: all-cause death, cardiovascular death, unplanned hospitalization for heart failure, and revascularization. All adverse clinical events as well as study end points were monitored and adjudicated by the independent event committee.

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing
    • Peking, Beijing, China, 100853
      • Chinese People's Liberation Army General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• STEMI patients: typical chest pain lasting 30 min within the previous 12 h, a clear ST-segment elevation of N0.1 mV in ≥2 contiguous electrocardiographic leads, and elevated blood levels of troponin T
• patients were scheduled to undergo diagnostic cardiac angiography or percutaneous coronary interventions

Exclusion Criteria:

• had once treated by ivabradine
• history of myocardial infarction
• mechanical complications
• Unable to perform myocardial MRI
• liver and kidney failure
• malignant tumor
• unconscious
• Patients with other significant abnormal signs, laboratory tests and clinical disease are unsuitable for participation in the study accessed by clinicians.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: The control group
Experimental: Cardiomyopeptidin group; The Cardiomyopeptidin group received intravenous infusion 3 mg/(kg·d) of cardiomyopeptidin during the PCI until 3 days after operation	Drug: cardiomyopeptidin; cardiomyopeptidin intervention group will accept cardiomyopeptidin (Dalian Zhenao Pharmaceutical Co., Ltd., approval number: National Drug Approval No. H20052173, specification: 20 mg/tube) 3 mg/(kg·d)；

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Myocardial infarct size according to MR delayed enhancement scan	Two experienced MRI cardiologists analyzed the delayed enhancement image	7 days after PCI

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACEs	MACEs concluding all-cause death, cardiovascular death, unplanned hospitalization for heart failure, and revascularization	follow up in six months
myocardial edema area	Two experienced MRI cardiologists analyzed the delayed enhancement image	7 days after PCI
microvascular obstruction and left ventricular ejection fraction	Two experienced MRI cardiologists analyzed the delayed enhancement image	7 days after PCI
incidence of slow flow/no-reflow	Angiographic slow/no-reflow during PCI was defined as thrombolysis in myocardial infarction (TIMI) flow grade ≤ 2 during the procedure without evidence of dissection	Immediately after PCI
corrected thrombolysis in myocardial infarction (TIMI) frame count (cTFC);	The cTFC was measured by two cardiologists, and the average value was taken. When scanning at a rate of 15 frames per second, cTFC > 20 frames per second was used as the criterion for the diagnosis of slow blood flow after primary PCI.	Immediately after PCI
ST-segment fall rate of electrocardiogram (ECG)		6 hours, 12 hours, 24 hours after myocardial infarction

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital
• Collaborators: Dalian Zhen-Ao Bio-Tech Co., Ltd.

Publications and helpful links

General Publications

• Korosoglou G, Giusca S, Montenbruck M, Patel AR, Lapinskas T, Gotze C, Zieschang V, Al-Tabatabaee S, Pieske B, Florian A, Erley J, Katus HA, Kelle S, Steen H. Fast Strain-Encoded Cardiac Magnetic Resonance for Diagnostic Classification and Risk Stratification of Heart Failure Patients. JACC Cardiovasc Imaging. 2021 Jun;14(6):1177-1188. doi: 10.1016/j.jcmg.2020.10.024. Epub 2021 Jan 13.
• Der P, Cui J, Das DK. Role of lipid rafts in ceramide and nitric oxide signaling in the ischemic and preconditioned hearts. J Mol Cell Cardiol. 2006 Feb;40(2):313-20. doi: 10.1016/j.yjmcc.2005.10.005. Epub 2005 Dec 9.
• Salloum FN, Ockaili RA, Wittkamp M, Marwaha VR, Kukreja RC. Vardenafil: a novel type 5 phosphodiesterase inhibitor reduces myocardial infarct size following ischemia/reperfusion injury via opening of mitochondrial K(ATP) channels in rabbits. J Mol Cell Cardiol. 2006 Mar;40(3):405-11. doi: 10.1016/j.yjmcc.2005.10.002. Epub 2006 Feb 9.
• Yang LP, Kong XP, Li RB, Zeng PL. [Recovery effect of cardiomyopeptidin fractions and fraction addition on cardiac muscle cells in rats damaged by adriamycin]. Zhongguo Zhong Yao Za Zhi. 2000 Jun;25(6):362-3. Chinese.
• Yang LP, Wan HY, Kong XP, Wu Y, Teng J, Fan LL. [Preventive effect of cardiomyopeptidin on rat heart injured by ischemia-reperfusion]. Zhongguo Zhong Yao Za Zhi. 2000 Feb;25(2):105-7. Chinese.
• Yang L, Chen L, Zhang G, Liu X, Chen D, Dong Y. [Effect of cardiomyopeptidin for injection on energy metabolism in isolated hearts of young rats after ischemia-reperfusion injury]. Zhong Nan Da Xue Xue Bao Yi Xue Ban. 2010 Jun;35(6):598-606. doi: 10.3969/j.issn.1672-7347.2010.06.010. Chinese.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: November 25, 2023
• First Submitted That Met QC Criteria: December 1, 2023
• First Posted (Estimated): December 4, 2023

Study Record Updates

• Last Update Posted (Estimated): December 4, 2023
• Last Update Submitted That Met QC Criteria: December 1, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 2023QG-1124

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No