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

Cardiovascular Diseases Clinical Trial

Official title:

Chinese People's Liberation Army General Hospital

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06155110
• Other study ID #: 2023QG-1124
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: March 1, 2022
• Est. completion date: May 1, 2024

Study information

• Verified date: November 2023
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: May 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

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);

Locations

Country	Name	City	State
China	Chinese People's Liberation Army General Hospital	Peking	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Chinese PLA General Hospital	Dalian Zhen-Ao Bio-Tech Co., Ltd.

Country where clinical trial is conducted

China, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myocardial infarct size according to MR delayed enhancement scan	Two experienced MRI cardiologists analyzed the delayed enhancement image	7 days after PCI
Secondary	MACEs	MACEs concluding all-cause death, cardiovascular death, unplanned hospitalization for heart failure, and revascularization	follow up in six months
Secondary	myocardial edema area	Two experienced MRI cardiologists analyzed the delayed enhancement image	7 days after PCI
Secondary	microvascular obstruction and left ventricular ejection fraction	Two experienced MRI cardiologists analyzed the delayed enhancement image	7 days after PCI
Secondary	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
Secondary	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
Secondary	ST-segment fall rate of electrocardiogram (ECG)		6 hours, 12 hours, 24 hours after myocardial infarction