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

NCT ID: NCT01578876

Last Updated: 2012-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2012-01-31

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

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CSWT for 3 month

A group

Group Type: EXPERIMENTAL

cardiac shock wave therapy(CSWT)

Intervention Type: DEVICE

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.

CSWT for 1 month

B group

Group Type: EXPERIMENTAL

cardiac shock wave therapy(CSWT)

Intervention Type: DEVICE

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.

Control group

C group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

SW

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 81 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kunming Medical University

OTHER

Sponsor Role: lead

Responsible Party

Guo Tao

Director of Cardiovascular Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guo Tao, MD

Role: STUDY_DIRECTOR

Kunming Medical University

Locations

Cardiovascular Center

Kunming, Yunnan, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 26875905 (View on PubMed)

Other Identifiers

CSWT IN CHINA

Identifier Type: -

Identifier Source: org_study_id