Clinical Efficacy of Extracorporeal Cardiac Shock Wave Therapy in Patients With Ischemia-reperfusion Injury

NCT05624203 | Unknown DMC

• 1 other identifier: 1stKunmingMCYN
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

This trial was a prospective, open-label, single-center, randomized trial, To observe the clinical efficacy of extracorporeal cardiac shock wave in the treatment of patients with myocardial ischemia-reperfusion injury and the difference in the level of endothelial progenitor cell-derived miR-140-3p in patients with myocardial ischemia-reperfusion injury treated with extracorporeal cardiac shock wave and control group and its relationship with clinical efficacy and prognosis. In order to provide a new therapy for patients with myocardial ischemia-reperfusion injury.

Conditions

Myocardial Reperfusion Injury; Treatment Outcome; Prognosis; ST Elevation Myocardial Infarction

Keywords

extracorporeal cardiac shock waves; Endothelial progenitor cell; miR-140-3p

Outcome Measures

Primary Outcomes (1)

• A composite of death, myocardial infarction, or cerebrovascular events

  24 months after the index procedure

  24months

Secondary Outcomes (6)

• Expression level of miR-140-3p

  1, 2, 3, 6, 12 and 24 months

• All cause Death

  2 years

• cardiac death

  2 years

• Myocardial infarction (MI)

  2 years

• Cerebrovascular accident (CVA)

  2 years

Study Arms (2)

Extracorporeal cardiac shock wave therapy was performed（ECSW）

EXPERIMENTAL

Patients with acute ST-segment elevation myocardial infarction who underwent Percutaneous coronary intervention (PCI) were treated with extracorporeal cardiac shock wave therapy 2-3 days after operation. The duration of treatment was 3 months, and 9 treatments were completed within 3 months as a course. One week of treatment was followed by a 3-week rest in each month. CSWT was performed three times in each treatment week, respectively on the 1st, 3rd, and 5th day of the treatment week, for a total of 3 months.

Device: Extracorporeal cardiac shock wave therapy(ECSW)

Extracorporeal cardiac shock wave therapy was not performed（NO ECSW）

NO INTERVENTION

Patients with acute ST-segment elevation myocardial infarction undergoing Percutaneous coronary intervention (PCI) are not treated with extracorporeal cardiac shock wave

Interventions

Extracorporeal cardiac shock wave therapy(ECSW) DEVICE

Extracorporeal cardiac shock wave therapy (CSWT) is a cutting-edge technology developed in the world for more than 20 years. It is mainly used in the treatment of refractory angina pectoris of coronary heart disease. The mechanism of extracorporeal cardiac shock wave therapy is mainly due to the small attenuation, small shear stress and strong penetration force of shock wave when propagating in human tissues. Shear stress and hole effect are generated in the focal area of shock wave, which leads to the repeated formation/rupture of microbubbles in tissue/cell microenvironment, resulting in various physical and biological effects. These physical mechanisms trigger a series of biological effects, such as promoting the expression of various intracellular cytokines and angiogenic factors, activating related signal transduction pathways, inhibiting apoptosis and oxidative stress, and finally increasing the number of new blood vessels in the treatment area and improving the ischemic state.

Extracorporeal cardiac shock wave therapy was performed（ECSW）

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years The patient was diagnosed with acute ST-segment elevation myocardial infarction for the first time, and coronary angiography showed moderate to severe coronary artery stenosis. PCI was performed within 12 hours of the onset of the disease according to the current guidelines, and postoperative hemodynamic stability was achieved CCS angina pectoris grade Ⅱ or above, NYHA cardiac function grade I-Ⅲ Imaging examination \[stress echocardiography and/or stress myocardial perfusion imaging\] suggested objective evidence of reversible myocardial ischemia Voluntary participation, able to cooperate with treatment and follow-up, signed informed consent.

You may not qualify if:

• severe unprotected left main stem lesions Left ventricular systolic function was impaired with hemodynamic instability chronic obstructive pulmonary disease, pulmonary maculopathy, post-pseudobulbar placement or other causes of poor sonographic window Combined with chest malignant tumor pregnancy The skin of the treatment area is broken or infected NYHA cardiac function grade Ⅳ Acute myocarditis, pericarditis, moderate or large amount of pericardial effusion, infective endocarditis, deep vein thrombosis, intracardiac thrombosis; Severe aortic stenosis, aortic aneurysm, thoracic aortic dissection, thoracic aortic aneurysm, after heart transplantation, metal heart valve replacement, pulmonary embolism patients undergoing thrombolysis and surgical bypass Patients with a history of mental illness, poor compliance and inability to cooperate.

Sponsors & Collaborators

• First Affiliated Hospital of Kunming Medical University: lead

Related Publications (13)

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  PMID: 22064429 BACKGROUND

• Bulluck H, Yellon DM, Hausenloy DJ. Reducing myocardial infarct size: challenges and future opportunities. Heart. 2016 Mar;102(5):341-8. doi: 10.1136/heartjnl-2015-307855. Epub 2015 Dec 16.

  PMID: 26674987 BACKGROUND

• Hausenloy DJ, Yellon DM. Myocardial ischemia-reperfusion injury: a neglected therapeutic target. J Clin Invest. 2013 Jan;123(1):92-100. doi: 10.1172/JCI62874. Epub 2013 Jan 2.

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• Sahoo S, Klychko E, Thorne T, Misener S, Schultz KM, Millay M, Ito A, Liu T, Kamide C, Agrawal H, Perlman H, Qin G, Kishore R, Losordo DW. Exosomes from human CD34(+) stem cells mediate their proangiogenic paracrine activity. Circ Res. 2011 Sep 16;109(7):724-8. doi: 10.1161/CIRCRESAHA.111.253286. Epub 2011 Aug 11.

  PMID: 21835908 BACKGROUND

• Arslan F, Lai RC, Smeets MB, Akeroyd L, Choo A, Aguor EN, Timmers L, van Rijen HV, Doevendans PA, Pasterkamp G, Lim SK, de Kleijn DP. Mesenchymal stem cell-derived exosomes increase ATP levels, decrease oxidative stress and activate PI3K/Akt pathway to enhance myocardial viability and prevent adverse remodeling after myocardial ischemia/reperfusion injury. Stem Cell Res. 2013 May;10(3):301-12. doi: 10.1016/j.scr.2013.01.002. Epub 2013 Jan 14.

  PMID: 23399448 BACKGROUND

• Kooijmans SA, Vader P, van Dommelen SM, van Solinge WW, Schiffelers RM. Exosome mimetics: a novel class of drug delivery systems. Int J Nanomedicine. 2012;7:1525-41. doi: 10.2147/IJN.S29661. Epub 2012 Mar 16.

  PMID: 22619510 BACKGROUND

• Feng Y, Huang W, Wani M, Yu X, Ashraf M. Ischemic preconditioning potentiates the protective effect of stem cells through secretion of exosomes by targeting Mecp2 via miR-22. PLoS One. 2014 Feb 18;9(2):e88685. doi: 10.1371/journal.pone.0088685. eCollection 2014.

  PMID: 24558412 BACKGROUND

• Gollmann-Tepekoylu C, Polzl L, Graber M, Hirsch J, Nagele F, Lobenwein D, Hess MW, Blumer MJ, Kirchmair E, Zipperle J, Hromada C, Muhleder S, Hackl H, Hermann M, Al Khamisi H, Forster M, Lichtenauer M, Mittermayr R, Paulus P, Fritsch H, Bonaros N, Kirchmair R, Sluijter JPG, Davidson S, Grimm M, Holfeld J. miR-19a-3p containing exosomes improve function of ischaemic myocardium upon shock wave therapy. Cardiovasc Res. 2020 May 1;116(6):1226-1236. doi: 10.1093/cvr/cvz209.

  PMID: 31410448 BACKGROUND

• Kikuchi Y, Ito K, Shindo T, Hao K, Shiroto T, Matsumoto Y, Takahashi J, Matsubara T, Yamada A, Ozaki Y, Hiroe M, Misumi K, Ota H, Takanami K, Hiraide T, Takase K, Tanji F, Tomata Y, Tsuji I, Shimokawa H. A multicenter trial of extracorporeal cardiac shock wave therapy for refractory angina pectoris: report of the highly advanced medical treatment in Japan. Heart Vessels. 2019 Jan;34(1):104-113. doi: 10.1007/s00380-018-1215-4. Epub 2018 Jun 25.

  PMID: 29942978 BACKGROUND

• Kagaya Y, Ito K, Takahashi J, Matsumoto Y, Shiroto T, Tsuburaya R, Kikuchi Y, Hao K, Nishimiya K, Shindo T, Ogata T, Kurosawa R, Eguchi K, Monma Y, Ichijo S, Hatanaka K, Miyata S, Shimokawa H. Low-energy cardiac shockwave therapy to suppress left ventricular remodeling in patients with acute myocardial infarction: a first-in-human study. Coron Artery Dis. 2018 Jun;29(4):294-300. doi: 10.1097/MCA.0000000000000577.

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• Cai HY, Li L, Guo T, Wang YU, Ma TK, Xiao JM, Zhao L, Fang Y, Yang P, Zhao HU. Cardiac shockwave therapy improves myocardial function in patients with refractory coronary artery disease by promoting VEGF and IL-8 secretion to mediate the proliferation of endothelial progenitor cells. Exp Ther Med. 2015 Dec;10(6):2410-2416. doi: 10.3892/etm.2015.2820. Epub 2015 Oct 20.

  PMID: 26668649 BACKGROUND

• Yang D, Wang M, Hu Z, Ma Y, Shi Y, Cao X, Guo T, Cai H, Cai H. Extracorporeal Cardiac Shock Wave-Induced Exosome Derived From Endothelial Colony-Forming Cells Carrying miR-140-3p Alleviate Cardiomyocyte Hypoxia/Reoxygenation Injury via the PTEN/PI3K/AKT Pathway. Front Cell Dev Biol. 2022 Jan 10;9:779936. doi: 10.3389/fcell.2021.779936. eCollection 2021.

  PMID: 35083214 BACKGROUND

• Li X, Zhang C, Liu C, Ma Y, Shi Y, Ye Y, Ma X, Liu Y, Luo X, Lin F, Wang J, Tao J, Lun J, Cai H, Hu Z. Principle and design of clinical efficacy observation of extracorporeal cardiac shock wave therapy for patients with myocardial ischemia-reperfusion injury: A prospective randomized controlled trial protocol. PLoS One. 2023 Dec 8;18(12):e0294060. doi: 10.1371/journal.pone.0294060. eCollection 2023.

  PMID: 38064454 DERIVED

MeSH Terms

Conditions

Myocardial Reperfusion Injury; ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Myocardial Ischemia; Vascular Diseases; Reperfusion Injury; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Myocardial Infarction; Infarction; Ischemia; Necrosis

Study Officials

• Cai Hongyan, Dr.

  First Affiliated Hospital of Kunming Medical University

  STUDY DIRECTOR

Central Study Contacts

li Xian-bin, master

CONTACT

+8618469110649; kmykdx@yeah.net

ma Yi-ming, Dr.

CONTACT

+8615198810061

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients with acute ST-segment elevation myocardial infarction undergoing Percutaneous coronary intervention (PCI) were randomly divided into extracorporeal cardiac shock wave treatment group and blank control group.

Study Record Dates

• First Submitted: November 3, 2022
• First Posted: November 22, 2022
• Study Start: December 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 30, 2024
• Last Updated: November 22, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share