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 Details — Status: Completed

Administrative data

• NCT number: NCT01578876
• Other study ID #: CSWT IN CHINA
• Status: Completed
• Phase: Phase 3
• First received: February 19, 2012
• Last updated: April 17, 2012
• Start date: December 2008
• Est. completion date: January 2012

Study information

• Verified date: April 2012
• Source: Kunming Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: January 2012
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 81 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• cardiac shock wave therapy(CSWT)
CSWT was performed with the MODULITH SLC SW therapy device (Storz Medical, Switzerland).Shock waves were triggered by the R-wave of the ECG when the instrument was activated. The shock wave energy was increased from an initial low level up 0.09 mJ/mm2 if the patient experienced no discomfort such as chest pain. Point-to-point combination treatment for the ischemic areas with 200 pulses delivered to each point was given.

Locations

Country	Name	City	State
China	Cardiovascular Center	Kunming	Yunnan

Sponsors (1)

Lead Sponsor	Collaborator
Kunming Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Extracorporeal Cardiac Shock Wave Therapy (CSWT) for Treatment of Coronary Artery Disease	Outcome measure included clinical assessment and morphological assessment	3 years	Yes