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

Last updated: April 17, 2012
Sponsor: Kunming Medical University
Overall Status: Completed

Phase

3

Condition

Coronary Artery Disease

Chest Pain

Cardiovascular Disease

Treatment

N/A

Clinical Study ID

NCT01578876
CSWT IN CHINA
  • Ages 35-81
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • coronary angiography or multi-slice spiral ct coronary angiography suggestive ofmoderate to severe coronary artery stenosis.

  • Chest tightness, onset of shortness of breath, and poor exercise tolerance afterreceiving 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 YorkHeart Association functional classification of I-III.

  • More than 1 month after acute myocardial infarction (AMI) and more than 2 weeks afterPCI surgery. The diagnosis and treatment in all the patients was in accordance withthe related domestic and European guidelines developed in 2007.

Exclusion

Exclusion Criteria:

  • Acute myocardial infarction or coronary artery bypass graft within the 4 weeks priorto 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 Design

Total Participants: 55
Study Start date:
December 01, 2008
Estimated Completion Date:
January 31, 2012

Study 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

Connect with a study center

  • Cardiovascular Center

    Kunming, Yunnan 0871
    China

    Site Not Available

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