Improvement of Cardiac Function in Patients With Ischemic Cardiomyopathy by Extracorporeal Shock Wave Therapy: a Multicenter Clinical Study
NCT ID: NCT03398096
Last Updated: 2018-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2018-03-30
2018-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Cardiac shock wave therapy (CSWT) group
The CWST group were performed with a CSWT equipment (Storz Medical, Switzerland) followed the recommended protocol developed by Tohoku University of Japan with respect to the shockwave output and the number of shots implemented to each spot and the protocol developed by the University of Essen, Germany.
Cardiac shock wave therapy
Ultrasound guided cardiac shock wave therapy (CSWT) is a new treatment method offering an alternative to revascularization by stimulating angiogenesis. Subsequent clinical trials showed that CSWT could reduce symptoms of myocardial ischemia and improve cardiac function in patients with severe coronary artery disease.
Control group
No CWST treatment.
No interventions assigned to this group
Interventions
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Cardiac shock wave therapy
Ultrasound guided cardiac shock wave therapy (CSWT) is a new treatment method offering an alternative to revascularization by stimulating angiogenesis. Subsequent clinical trials showed that CSWT could reduce symptoms of myocardial ischemia and improve cardiac function in patients with severe coronary artery disease.
Eligibility Criteria
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Inclusion Criteria
* Coronary angiography (CA) or multi-slice CT coronary angiography (CTCA) suggestive of moderate to severe coronary artery stenosis;
* Chest tightness, onset of shortness of breath, and poor exercise tolerance after receiving formal drug treatment (with or without stent or bypass graft);
* Hospitalized more than 2 times within 1 year due to the aforementioned problems;
* CCS angina grading higher than grade II, and New York Heart Association (NYHA) class I-III;
* More than 1 month after acute myocardial infarction (AMI) and 1 month after percutaneous coronary intervention (PCI) surgery.
Exclusion Criteria
* History of heart transplantation;
* History of metal valve replacement surgery;
* Intra-cardiac thrombus;
* Left Ventricular Ejection Fraction (LVEF) \< 30 % and unstable hemodynamics;
* Arrhythmia with a rate \< 40 bpm or \> 120 bpm;
* Skin ulceration or infection in the treatment area;
* Severe obstructive lung disease.
18 Years
80 Years
ALL
No
Sponsors
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Shanghai 10th People's Hospital
OTHER
Responsible Party
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Ya-Wei Xu
Professor
Locations
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Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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References
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Weijing L, Ximin F, Jianying S, Mengyun Z, Xuehua F, Yawei X, Liqiong H. Cardiac Shock Wave Therapy Ameliorates Myocardial Ischemia in Patients With Chronic Refractory Angina Pectoris: A Randomized Trial. Front Cardiovasc Med. 2021 Jul 21;8:664433. doi: 10.3389/fcvm.2021.664433. eCollection 2021.
Other Identifiers
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CSWT
Identifier Type: -
Identifier Source: org_study_id
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