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

Phase 3

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: cardiac shock wave therapy(CSWT)

• Registration Number: NCT01578876
• Lead Sponsor: Kunming Medical University

Brief 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.

Detailed 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 Timeline

• Study Start: 2008-12
• Primary Completion: 2011-05
• Study Completion: 2012-01
• Study First Submitted: 2012-02-19
• Status Verified: 2012-04
• Study First Submitted QC: 2012-04-16
• Study First Posted: 2012-04-17
• Last Update Submitted: 2012-04-17
• Last Update Posted: 2012-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

• coronary angiography or multi-slice spiral ct coronary angiography 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.
• Canadian Cardiovascular Society angina grading higher than grade II, and New York Heart Association functional classification of I-III.
• 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.

Exclusion Criteria

• Acute myocardial infarction or coronary artery bypass graft within the 4 weeks prior to the study.
• History of heart transplantation.
• History of metal valve replacement surgery.
• Intracardiac thrombus.
• Left ventricular ejection fraction < 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CSWT for 3 month	cardiac shock wave therapy(CSWT)	A group
CSWT for 1 month	cardiac shock wave therapy(CSWT)	B group

Primary Outcome Measures

Name	Time	Method
Extracorporeal Cardiac Shock Wave Therapy (CSWT) for Treatment of Coronary Artery Disease	3 years	Outcome measure included clinical assessment and morphological assessment

Trial Locations

Locations (1)

Cardiovascular Center; 🇨🇳 Kunming, Yunnan, China