Clinical trial NCT01578876: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Artery Disease
Keywords: coronary artery disease
angina pectoris
myocardial ischemia
cardiac shock wave therapy
Lead sponsor: Kunming Medical University
Sponsor class: OTHER
First posted: 2012-04-17
Enrollment: 55
Sex: ALL
Minimum age (years): 35
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Extracorporeal Cardiac Shock Wave Therapy (CSWT) for Treatment of Coronary Artery Disease
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Kunming
country: China
facility: Cardiovascular Center
state: Yunnan
Study officials:
affiliation: Kunming Medical University
name: Guo Tao, MD
role: STUDY_DIRECTOR
References:
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.