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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
cardiac shock wave therapy(CSWT)
Sponsored by
Kunming Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring coronary artery disease, angina pectoris, myocardial ischemia, cardiac shock wave therapy

Eligibility Criteria

35 Years - 81 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Cardiovascular Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

CSWT for 3 month

CSWT for 1 month

Control group

Arm Description

A group

B group

C group

Outcomes

Primary Outcome Measures

Extracorporeal Cardiac Shock Wave Therapy (CSWT) for Treatment of Coronary Artery Disease
Outcome measure included clinical assessment and morphological assessment

Secondary Outcome Measures

Full Information

First Posted
February 19, 2012
Last Updated
April 17, 2012
Sponsor
Kunming Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01578876
Brief Title
Extracorporeal Cardiac Shock Wave Therapy (CSWT) for Treatment of Coronary Artery Disease
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.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kunming Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
coronary artery disease, angina pectoris, myocardial ischemia, cardiac shock wave therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CSWT for 3 month
Arm Type
Experimental
Arm Description
A group
Arm Title
CSWT for 1 month
Arm Type
Experimental
Arm Description
B group
Arm Title
Control group
Arm Type
No Intervention
Arm Description
C group
Intervention Type
Device
Intervention Name(s)
cardiac shock wave therapy(CSWT)
Other Intervention Name(s)
SW
Intervention Description
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.
Primary Outcome Measure Information:
Title
Extracorporeal Cardiac Shock Wave Therapy (CSWT) for Treatment of Coronary Artery Disease
Description
Outcome measure included clinical assessment and morphological assessment
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
81 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guo Tao, MD
Organizational Affiliation
Kunming Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Cardiovascular Center
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
0871
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
26875905
Citation
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.
Results Reference
derived

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

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