Improvement of Cardiac Function in Patients With Ischemic Cardiomyopathy by Extracorporeal Shock Wave Therapy: a Multicenter Clinical Study

Study Overview
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Brief Summary
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Cardiac shock wave therapy (CSWT) is a noninvasive new therapeutic option in the treatment of chronic refractory angina pectoris. Many domestic and international researches have revealed that CSWT contributes to revascularization by stimulating angiogenesis. We were aimed to evaluate the safety and efficiency of CSWT in the treatment of refractory angina.

Official Title
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Improvement of Cardiac Function in Patients With Ischemic Cardiomyopathy by Extracorporeal Shock Wave Therapy: a Multicenter Clinical Study

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Cardiac shock wave therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients were 18 to 80 years old; Coronary angiography (CA) or multi-slice CT coronary angiography (CTCA) 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; CCS angina grading higher than grade II, and New York Heart Association (NYHA) class I-III; More than 1 month after acute myocardial infarction (AMI) and 1 month after percutaneous coronary intervention (PCI) surgery. Exclusion Criteria: AMI、PCI or coronary artery bypass graft (CABG) within the 4 weeks prior to the study; History of heart transplantation; History of metal valve replacement surgery; Intra-cardiac thrombus; Left Ventricular Ejection Fraction (LVEF) < 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cardiac shock wave therapy (CSWT) group<br>The CWST group were performed with a CSWT equipment (Storz Medical, Switzerland) followed the recommended protocol developed by Tohoku University of Japan with respect to the shockwave output and the number of shots implemented to each spot and the protocol developed by the University of Essen, Germany. | Device: Cardiac shock wave therapy<br>* Ultrasound guided cardiac shock wave therapy (CSWT) is a new treatment method offering an alternative to revascularization by stimulating angiogenesis. Subsequent clinical trials showed that CSWT could reduce symptoms of myocardial ischemia and improve cardiac function in patients with severe coronary artery disease.<br>|
| No Intervention: Control group<br>No CWST treatment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Canadian Cardiovascular Society (CCS) grading of angina | questionnaire of Canadian Cardiovascular Society grading of angina concerning exercise tolerance | 6 months | 
| Seattle angina questions (SAQ) | questionnaire of Seattle angina questions to evaluate the effect of coronary artery disease on patients' life quality | 6 months | 
| 6-min walk test | All participants will receive a 6 minutes' walk test to evaluate their effect of treatment of cardiac shock wave therapy | 6 months | 
| Nitrate consumption | All participants will receive a questionnaire of the amount of nitrate they need before and after treatment of cardiac shock wave therapy | 6 months |