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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03398096
Recruitment Status : Unknown
Verified January 2018 by Ya-Wei Xu, Shanghai 10th People's Hospital.
Recruitment status was:  Not yet recruiting
First Posted : January 12, 2018
Last Update Posted : January 12, 2018
Sponsor:
Information provided by (Responsible Party):
Ya-Wei Xu, Shanghai 10th People's Hospital

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : March 30, 2018
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Canadian Cardiovascular Society (CCS) grading of angina [ Time Frame: 6 months ]
    questionnaire of Canadian Cardiovascular Society grading of angina concerning exercise tolerance

  2. 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

  3. 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

  4. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03398096


Contacts
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Contact: Weijing Liu 18917684041 liuweijing98@sina.com

Locations
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China, Shanghai
Shanghai Tenth People's Hospital
Shanghai, Shanghai, China, 200072
Sponsors and Collaborators
Shanghai 10th People's Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ya-Wei Xu, Professor, Shanghai 10th People's Hospital
ClinicalTrials.gov Identifier: NCT03398096    
Other Study ID Numbers: CSWT
First Posted: January 12, 2018    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Cardiomyopathies
Coronary Disease
Myocardial Ischemia
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases