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

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.

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: cardiac shock wave therapy(CSWT)

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 Type: Interventional
• Enrollment (Actual): 55
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Yunnan
    • Kunming, Yunnan, China, 0871
      • Cardiovascular Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 81 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: SW
NO_INTERVENTION: Control group; C group

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Kunming Medical University
• Investigators: Study Director: Guo Tao, MD, Kunming Medical University

Publications and helpful links

General Publications

• Nirala S, Wang Y, Peng YZ, Yang P, Guo T. Cardiac shock wave therapy shows better outcomes in the coronary artery disease patients in a long term. Eur Rev Med Pharmacol Sci. 2016;20(2):330-8.

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (ACTUAL): May 1, 2011
• Study Completion (ACTUAL): January 1, 2012

Study Registration Dates

• First Submitted: February 19, 2012
• First Submitted That Met QC Criteria: April 16, 2012
• First Posted (ESTIMATE): April 17, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): April 19, 2012
• Last Update Submitted That Met QC Criteria: April 17, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: coronary artery disease; angina pectoris; myocardial ischemia; cardiac shock wave therapy
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: CSWT IN CHINA