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

Primary Purpose

Coronary Artery Disease

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Cardiac shock wave therapy
Sponsored by
Shanghai 10th People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Shanghai Tenth People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cardiac shock wave therapy (CSWT) group

Control group

Arm 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.

No CWST treatment.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 14, 2017
Last Updated
January 7, 2018
Sponsor
Shanghai 10th People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03398096
Brief Title
Improvement of Cardiac Function in Patients With Ischemic Cardiomyopathy by Extracorporeal Shock Wave Therapy: a Multicenter Clinical Study
Official Title
Improvement of Cardiac Function in Patients With Ischemic Cardiomyopathy by Extracorporeal Shock Wave Therapy: a Multicenter Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 30, 2018 (Anticipated)
Primary Completion Date
June 30, 2018 (Anticipated)
Study Completion Date
September 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai 10th People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cardiac shock wave therapy (CSWT) group
Arm Type
Experimental
Arm 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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No CWST treatment.
Intervention Type
Device
Intervention Name(s)
Cardiac shock wave therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Canadian Cardiovascular Society (CCS) grading of angina
Description
questionnaire of Canadian Cardiovascular Society grading of angina concerning exercise tolerance
Time Frame
6 months
Title
Seattle angina questions (SAQ)
Description
questionnaire of Seattle angina questions to evaluate the effect of coronary artery disease on patients' life quality
Time Frame
6 months
Title
6-min walk test
Description
All participants will receive a 6 minutes' walk test to evaluate their effect of treatment of cardiac shock wave therapy
Time Frame
6 months
Title
Nitrate consumption
Description
All participants will receive a questionnaire of the amount of nitrate they need before and after treatment of cardiac shock wave therapy
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weijing Liu
Phone
18917684041
Email
liuweijing98@sina.com
Facility Information:
Facility Name
Shanghai Tenth People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200072
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
34368242
Citation
Weijing L, Ximin F, Jianying S, Mengyun Z, Xuehua F, Yawei X, Liqiong H. Cardiac Shock Wave Therapy Ameliorates Myocardial Ischemia in Patients With Chronic Refractory Angina Pectoris: A Randomized Trial. Front Cardiovasc Med. 2021 Jul 21;8:664433. doi: 10.3389/fcvm.2021.664433. eCollection 2021.
Results Reference
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Improvement of Cardiac Function in Patients With Ischemic Cardiomyopathy by Extracorporeal Shock Wave Therapy: a Multicenter Clinical Study

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