Extracorporeal Cardiac Shock Wave Therapy (CSWT) for Treatment of Coronary Artery Disease
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Artery Disease |
Device: cardiac shock wave therapy(CSWT) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| 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. |
- Extracorporeal Cardiac Shock Wave Therapy (CSWT) for Treatment of Coronary Artery Disease [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]Outcome measure included clinical assessment and morphological assessment
| Enrollment: | 55 |
| Study Start Date: | December 2008 |
| Study Completion Date: | January 2012 |
| Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: CSWT for 3 month
A group
|
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.
Other Name: SW
|
|
Experimental: CSWT for 1 month
B group
|
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.
Other Name: SW
|
|
No Intervention: Control group
C group
|
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
Eligibility| Ages Eligible for Study: | 35 Years to 81 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Guo Tao, Director of Cardiovascular Center, Kunming Medical College |
| ClinicalTrials.gov Identifier: | NCT01578876 History of Changes |
| Other Study ID Numbers: | CSWT IN CHINA |
| Study First Received: | February 19, 2012 |
| Last Updated: | April 17, 2012 |
| Health Authority: | China: Ministry of Health |
Keywords provided by Kunming Medical University:
|
coronary artery disease angina pectoris myocardial ischemia cardiac shock wave therapy |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on May 19, 2013