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

Tongji University

Status: Unknown

Conditions: Coronary Artery Disease

Treatments: Device: Cardiac shock wave therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03398096

CSWT

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Cardiac shock wave therapy (CSWT) group

Experimental group

Description:

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.

Treatment:

Device: Cardiac shock wave therapy

Control group

No Intervention group

Description:

No CWST treatment.