Implication of Cardiac Shock Wave Therapy on Coronary Artery Disease

Not Applicable

Completed

• Conditions: Cardiac Ischemia
• Interventions: Device: Cardiac shock wave therapy; Other: Sham cardiac shock wave (Control group)

• Registration Number: NCT03053128
• Lead Sponsor: Beijing Hospital

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.

Study Timeline

• Study Start: 2017-01-20
• Study First Submitted: 2017-02-07
• Study First Submitted QC: 2017-02-13
• Study First Posted: 2017-02-14
• Primary Completion: 2019-11-20
• Study Completion: 2019-11-20
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-14
• Last Update Posted: 2020-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CSWT group	Cardiac shock wave therapy	Patients in CSWT group will receive cardiac shock wave therapy for three moths, every first week of the month.
Sham CSWT group	Sham cardiac shock wave (Control group)	Patients in sham CSWT group will receive sham cardiac shock wave, which segregated by an air-cushion.

Primary Outcome Measures

Name	Time	Method
Myocardial perfusion score	1st week of fourth month from beginning of CSWT	Myocardial perfusion score will be calculated by myocardial perfusion imaging though single-photon computer tomography.
Ischemia area percentage	1st week of fourth month from beginning of CSWT	Ischemia area will be calculated by myocardial perfusion imaging though single-photon computer tomography.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Beijing Hospital; 🇨🇳 Beijing, Beijing, China