Implication of Cardiac Shock Wave Therapy on Coronary Artery Disease
CSWT
1 other identifier
interventional
30
1 country
1
Brief Summary
Coronary heart disease (CHD) is a public health care challenge. There are three types of treatment for CHD, medication, percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG). However, some end-stage CHD patients lost the chance to get those treatment. Cardiac shock wave therapy (CSWT) is a new developed therapy for these patients, which is used in tens of countries all over the world. Safety, invasiveness, effectiveness is its advantage. Ischemia condition can be improved after CSWT. There are only three cities in China run the program of CSWT, which are Kunming, Beijing and Shanghai. The investigators designed a randomized double-blind study to evaluate the effectiveness and safety of CSWT.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 20, 2017
CompletedFirst Submitted
Initial submission to the registry
February 7, 2017
CompletedFirst Posted
Study publicly available on registry
February 14, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 20, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 20, 2019
CompletedFebruary 18, 2020
February 1, 2020
2.8 years
February 7, 2017
February 14, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Myocardial perfusion score
Myocardial perfusion score will be calculated by myocardial perfusion imaging though single-photon computer tomography.
1st week of fourth month from beginning of CSWT
Ischemia area percentage
Ischemia area will be calculated by myocardial perfusion imaging though single-photon computer tomography.
1st week of fourth month from beginning of CSWT
Secondary Outcomes (6)
Cardiac wall motion amplitude
1st week of fourth month from beginning of CSWT
Left ventricular thickness rate
1st week of fourth month from beginning of CSWT
Cardiac enzyme
First week after CSWT
Angina score-SAQ
1st week of fourth month from beginning of CSWT
Quality of life (SF-36)
1st week of fourth month from beginning of CSWT
- +1 more secondary outcomes
Study Arms (2)
CSWT group
EXPERIMENTALPatients in CSWT group will receive cardiac shock wave therapy for three moths, every first week of the month.
Sham CSWT group
SHAM COMPARATORPatients in sham CSWT group will receive sham cardiac shock wave, which segregated by an air-cushion.
Interventions
Patients in CSWT group will receive CSWT for a 3-month therapy, located in their ischemia area with a energy of 0.09mJ/mm2. Patients will get therapy on every first week of the month and rest for following three weeks.
Patients in sham CSWT group will receive sham cardiac shock wave, which is segregated by an air cushion.
Eligibility Criteria
You may qualify if:
- Multiple or diffused coronary artery stenosis by coronary angiography and not candidate for PCI or CABG;
- Myocardial ischemia and/or cardiac dysfunction by objective exams;
- Angina and/or heart failure could not be control after optimal medication treatment for coronary artery disease;
- LVEF is above 30%;
- Signed informed consent
You may not qualify if:
- Acute myocardial infarction;
- Within one month after PCI or CABG;
- Heart transplant patient;
- Mechanic valve implantation patient;
- Uncontrolled heart failure with LVEF less than 30%;
- Severe arrhythmia;
- Pacemaker implantation patient;
- Infective endocarditis;
- Severe chronic obstructive pulmonary disease patient;
- Pregnant or nursing patient;
- Silicone breast forms patient;
- Chest tumor patient;
- Participant in other clinical trials at the same time.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Beijing Hospitallead
Study Sites (1)
Beijing Hospital
Beijing, Beijing Municipality, 100730, China
Related Publications (1)
Yu W, Shen T, Liu B, Wang S, Li J, Dai D, Cai J, He Q. Cardiac shock wave therapy attenuates H9c2 myoblast apoptosis by activating the AKT signal pathway. Cell Physiol Biochem. 2014;33(5):1293-303. doi: 10.1159/000358697. Epub 2014 Apr 28.
PMID: 24802592BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Qing He
Beijing Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Cinical professor and Principal investigator
Study Record Dates
First Submitted
February 7, 2017
First Posted
February 14, 2017
Study Start
January 20, 2017
Primary Completion
November 20, 2019
Study Completion
November 20, 2019
Last Updated
February 18, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share