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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Guo Tao, Kunming Medical College
ClinicalTrials.gov Identifier:
NCT01578876
First received: February 19, 2012
Last updated: April 17, 2012
Last verified: April 2012
  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.

Resource links provided by NLM:


Further study details as provided by Kunming Medical University:

Primary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01578876

Locations
China, Yunnan
Cardiovascular Center
Kunming, Yunnan, China, 0871
Sponsors and Collaborators
Kunming Medical University
Investigators
Study Director: Guo Tao, MD Kunming Medical University
  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 July 31, 2014