Implication of Cardiac Shock Wave Therapy on Coronary Artery Disease

NCT ID: NCT03053128

Last Updated: 2020-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-20
• Study Completion Date: 2019-11-20

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.

Detailed 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.

Conditions

Cardiac Ischemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

CSWT group

Patients in CSWT group will receive cardiac shock wave therapy for three moths, every first week of the month.

Group Type: EXPERIMENTAL

Cardiac shock wave therapy

Intervention Type: DEVICE

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.

Sham CSWT group

Patients in sham CSWT group will receive sham cardiac shock wave, which segregated by an air-cushion.

Group Type: SHAM_COMPARATOR

Sham cardiac shock wave (Control group)

Intervention Type: OTHER

Patients in sham CSWT group will receive sham cardiac shock wave, which is segregated by an air cushion.

Interventions

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.

Intervention Type: DEVICE

Sham cardiac shock wave (Control group)

Patients in sham CSWT group will receive sham cardiac shock wave, which is segregated by an air cushion.

Intervention Type: OTHER

Other Intervention Names

CSWT group; Sham CSWT group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Qing He

Cinical professor and Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Qing He

Role: PRINCIPAL_INVESTIGATOR

Beijing Hospital

Locations

Beijing Hospital

Beijing, Beijing Municipality, China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 24802592 (View on PubMed)

Other Identifiers

121-2016004

Identifier Type: -

Identifier Source: org_study_id