Implication of Cardiac Shock Wave Therapy on Coronary Artery Disease

Cardiac Ischemia Clinical Trial

— CSWT  

Official title:

Implication of Cardiac Shock Wave Therapy on Coronary Artery Disease: A Prospective Randomized Double-blind Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03053128
• Other study ID #: 121-2016004
• Status: Completed
• Phase: N/A
• Start date: January 20, 2017
• Est. completion date: November 20, 2019

Study information

• Verified date: February 2020
• Source: Beijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Coronary heart disease (CHD) is a public health care challenge, which lead to 3.5 millions of people died in China every year. 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 with severe cardiac ischemia lost the chance to get those treatment. Their quality of life is influenced by recurrent angina. Cardiac shock wave therapy (CSWT) is a new developed therapy for these patients, which is used in tens of countries all over the world. German and Japan are the countries earliest used CSWT. Safety, invasiveness, effectiveness is its advantage. Ischemia condition can be improved after CSWT by objective examination. New small vessels generation on ischemia area was found on mice and pig model. There are only three cities in China run the program of CSWT, that are Kunming, Beijing and Shanghai. Beijing hospital has the only CSWT machine in Beijing. The investigators designed a randomized double-blind study to evaluate the effectiveness and safety of CSWT.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 20, 2019
• Est. primary completion date: November 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Multiple or diffused coronary artery stenosis by coronary angiography and not candidate for PCI or CABG;

2. Myocardial ischemia and/or cardiac dysfunction by objective exams;

3. Angina and/or heart failure could not be control after optimal medication treatment for coronary artery disease;

4. LVEF is above 30%;

5. Signed informed consent

Exclusion Criteria:

1. Acute myocardial infarction;

2. Within one month after PCI or CABG;

3. Heart transplant patient;

4. Mechanic valve implantation patient;

5. Uncontrolled heart failure with LVEF less than 30%;

6. Severe arrhythmia;

7. Pacemaker implantation patient;

8. Infective endocarditis;

9. Severe chronic obstructive pulmonary disease patient;

10. Pregnant or nursing patient;

11. Silicone breast forms patient;

12. Chest tumor patient;

13. Participant in other clinical trials at the same time.

Related Conditions & MeSH terms

• Cardiac Ischemia
• Coronary Artery Disease
• Coronary Disease
• Ischemia
• Myocardial Ischemia

Intervention

Device:
• Cardiac shock wave therapy
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.

Other:
• Sham cardiac shock wave (Control group)
Patients in sham CSWT group will receive sham cardiac shock wave, which is segregated by an air cushion.

Locations

Country	Name	City	State
China	Beijing Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Hospital

Country where clinical trial is conducted

China, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Cardiac wall motion amplitude	Cardiac wall motion amplitude rate will be calculated by single-photon computer tomography.	1st week of fourth month from beginning of CSWT
Secondary	Left ventricular thickness rate	Left ventricular thickness rate will be calculated by single-photon computer tomography.	1st week of fourth month from beginning of CSWT
Secondary	Cardiac enzyme	Troponin T and troponin I will be tested at last time shock wave therapy of the first week.	First week after CSWT
Secondary	Angina score-SAQ	SAQ angina score will be finished after three month of CSWT.	1st week of fourth month from beginning of CSWT
Secondary	Quality of life (SF-36)	SF-36 questionnaire will be used for QOL.	1st week of fourth month from beginning of CSWT
Secondary	Six-minute of walk test	6MWT will be used for exertional capacity.	1st week of fourth month from beginning of CSWT