Clinical trial NCT03053128: Implication of Cardiac Shock Wave Therapy on Coronary Artery Disease
Official title: Implication of Cardiac Shock Wave Therapy on Coronary Artery Disease: A Prospective Randomized Double-blind Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Ischemia
Keywords: cardiac ischemia
Lead sponsor: Beijing Hospital
Sponsor class: OTHER_GOV
First posted: 2017-02-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Myocardial perfusion score
timeFrame: 1st week of fourth month from beginning of CSWT
measure: Ischemia area percentage
timeFrame: 1st week of fourth month from beginning of CSWT
Secondary outcomes:
measure: Cardiac wall motion amplitude
timeFrame: 1st week of fourth month from beginning of CSWT
measure: Left ventricular thickness rate
timeFrame: 1st week of fourth month from beginning of CSWT
measure: Cardiac enzyme
timeFrame: First week after CSWT
measure: Angina score-SAQ
timeFrame: 1st week of fourth month from beginning of CSWT
measure: Quality of life (SF-36)
timeFrame: 1st week of fourth month from beginning of CSWT
measure: Six-minute of walk test
timeFrame: 1st week of fourth month from beginning of CSWT
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
Study officials:
affiliation: Beijing Hospital
name: Qing He
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.