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

Sponsor

Shanghai 10th People's Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03398096

Collaborator

(none)

200

Enrollment

Location

Arms

Anticipated Duration (Months)

33.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Device: Cardiac shock wave therapy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Mar 30, 2018

Anticipated Primary Completion Date :

Jun 30, 2018

Anticipated Study Completion Date :

Sep 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cardiac shock wave therapy (CSWT) group 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 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.
No Intervention: Control group No CWST treatment.

Arm

Intervention/Treatment

Experimental: Cardiac shock wave therapy (CSWT) group

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

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.

No Intervention: Control group

No CWST treatment.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai Tenth People's Hospital	Shanghai	Shanghai	China	200072

Sponsors and Collaborators

Shanghai 10th People's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ya-Wei Xu, Professor, Shanghai 10th People's Hospital

ClinicalTrials.gov Identifier:

NCT03398096

Other Study ID Numbers:

CSWT

First Posted:

Jan 12, 2018

Last Update Posted:

Jan 12, 2018

Last Verified:

Jan 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Coronary Artery Disease

Cardiomyopathies

Study Results

No Results Posted as of Jan 12, 2018