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

Kunming Medical University

Status and phase: Completed; Phase 3

Conditions: Coronary Artery Disease

Treatments: Device: cardiac shock wave therapy(CSWT)

Study type: Interventional

Funder types: Other

Identifiers

NCT01578876

CSWT IN CHINA

Details and patient eligibility

About

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.

Full 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

Enrollment: 55 patients

Sex: All

Ages: 35 to 81 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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55 participants in 3 patient groups

CSWT for 3 month

Experimental group

Description:

A group

Treatment:

Device: cardiac shock wave therapy(CSWT)

CSWT for 1 month

Experimental group

Description:

B group

Treatment:

Device: cardiac shock wave therapy(CSWT)

Control group

No Intervention group

Description:

C group