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

January 7, 2018 updated by: Ya-Wei Xu, Shanghai 10th People's Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200072
        • Shanghai Tenth People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai 10th People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 30, 2018

Primary Completion (Anticipated)

June 30, 2018

Study Completion (Anticipated)

September 30, 2018

Study Registration Dates

First Submitted

December 14, 2017

First Submitted That Met QC Criteria

January 7, 2018

First Posted (Actual)

January 12, 2018

Study Record Updates

Last Update Posted (Actual)

January 12, 2018

Last Update Submitted That Met QC Criteria

January 7, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSWT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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