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Extracorporeal Cardiac Shock Wave Therapy (CSWT) for Treatment of Coronary Artery Disease

Coronary Artery Disease Clinical Trial

Official title:
To Prove up the Effect of CSWT in Vivo and to Evaluate the Feasibility and Efficiency of CSWT for Treatment of CAD and to Establish the Inclusion and Exclusion Criteria and Summarize the Methodological Outlines of CSWT in China.

Clinical Trial Summary

The purpose of this study is to determine the effectiveness of cardiac shock wave therapy (CSWT) for the treatment of severe coronary artery disease (CAD) in a Chinese cohort.

Clinical Trial Description

This study was approved by the Institutional Review Board and Ethics Committee of 1st Hospital of Kunming Medical University, and all study subjects signed informed consent for participation in the study and all treatments performed. Subjects were patients who were hospitalized at Department of Cardiology of our hospital from December 2008 to December 2009.

Patients were eligible to be included in the study if they met any of the following criteria: 1) Coronary angiography (CA) or multi-slice CT coronary angiography (CTCA) suggestive of moderate to severe coronary artery stenosis. 2) Chest tightness, onset of shortness of breath, and poor exercise tolerance after receiving formal drug treatment (with or without stent or bypass graft). 3) Hospitalized more than 2 times within 1 year due to the aforementioned problems. 4) CCS angina grading higher than grade II, and NYHA functional classification of I-III. 5) More than 1 month after acute myocardial infarction (AMI) and more than 2 weeks after PCI surgery. The diagnosis and treatment in all the patients was in accordance with the related domestic and European guidelines developed in 2007 ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01578876
Study type Interventional
Source Kunming Medical University
Contact
Status Completed
Phase Phase 3
Start date December 2008
Completion date January 2012
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