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

Not Applicable

• Conditions: Coronary Artery Disease
• Interventions: Device: Cardiac shock wave therapy

• Registration Number: NCT03398096
• Lead Sponsor: Shanghai 10th People's Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-14
• Status Verified: 2018-01
• Study First Submitted QC: 2018-01-07
• Last Update Submitted: 2018-01-07
• Study First Posted: 2018-01-12
• Last Update Posted: 2018-01-12
• Study Start: 2018-03-30
• Primary Completion: 2018-06-30
• Study Completion: 2018-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cardiac shock wave therapy (CSWT) group	Cardiac shock wave therapy	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Shanghai Tenth People's Hospital; 🇨🇳 Shanghai, Shanghai, China