Cardiac Ischemia
Conditions
Keywords
cardiac ischemia
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.
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.
OTHERSham cardiac shock wave (Control group)
Patients in sham CSWT group will receive sham cardiac shock wave, which is segregated by an air cushion.
Sponsors
Beijing Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Cardiac enzyme | First week after CSWT | Troponin T and troponin I will be tested at last time shock wave therapy of the first week. |
| Angina score-SAQ | 1st week of fourth month from beginning of CSWT | SAQ angina score will be finished after three month of CSWT. |
| 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. |
| Six-minute of walk test | 1st week of fourth month from beginning of CSWT | 6MWT will be used for exertional capacity. |
| Quality of life (SF-36) | 1st week of fourth month from beginning of CSWT | SF-36 questionnaire will be used for QOL. |
| 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. |
Countries
China
Outcome results
None listed