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| Name | Class |
|---|---|
| Dalian Zhen-Ao Bio-Tech Co., Ltd. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiomyopeptidin group | Experimental | The Cardiomyopeptidin group received intravenous infusion 3 mg/(kg·d) of cardiomyopeptidin during the PCI until 3 days after operation |
|
| The control group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cardiomyopeptidin | Drug | 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); |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese People's Liberation Army General Hospital | Beijing | Beijing Municipality | 100853 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16337960 | Background | 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. | |
| 16480739 | Background | 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. |
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| 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 |
| 12512426 | Background | 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. |
| 12212070 | Background | 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. |
| 20622333 | Background | 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. |
| 33454266 | Background | 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. |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C470986 | cardiomyopeptidin |
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