An observational study in Coronary Artery Disease, sponsored by Beijing Hospital. Status unknown at 1 site in China. Per ClinicalTrials.gov, last updated 2022-01-06.
Sponsored by Beijing Hospital · Observational
CAD is a challenging affliction which has a high annual morbidity rate in China and the world. Severe CAD may lead to compromised cardiac function, decreased exertional capacity and poor quality of life (QOL). The most common treatment for CAD is medication, percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG). However, some patients had long-term of history with complex severe artery lesions, they are not candidate for redo interventional therapy. Cardiac shock wave therapy (CSWT) is an exploring therapy used globally for CAD patients, which is known for its safety, non-invasiveness and effectiveness.The previous RCT from the investigators' team has already finished, and results are in submission processing.
This is a prospective, single arm, observational study design. CAD patients will be enrolled consecutively. The entire treatment period will last 3 months with 9 sessions. Outcomes are assessed as efficacy outcomes and safety outcomes. Efficacy outcomes include symptom (CCS score, NYHA classification, nitroglycerin dosage, SAQ questionnaire), exertional capacity (6MWT), quality of life (SF-36 questionnaire) and imaging evaluation (myocardial perfusion imaging and echocardiography). Safety outcome include the change of serum TNT, CKMB, BNP and adverse event (AE) occurrence. The participants will be followed up at 13th week, 6th months and 12th months.
CAD is a challenging affliction which has a high annual morbidity rate in China and the world. Severe CAD may lead to compromised cardiac function, decreased exertional capacity and poor quality of life (QOL). The most common treatment for CAD is medication, percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG). However, some patients had long-term of history with complex severe artery lesions, they are not candidate for redo interventional therapy. Cardiac shock wave therapy (CSWT) is an exploring therapy used globally for CAD patients, which is known for its safety, non-invasiveness and effectiveness. In the previous clinical studies, CSWT can alleviated angina symptom, improved myocardial ischemia and increased exertional capacity. Many single arm studies proved its efficacy and safety. Our RCT has already finished, and results are in submission processing.
This is a prospective, single arm, observational study design. CAD patients will be enrolled consecutively. The entire treatment period will last 3 months with 9 sessions. CSWT will be administered in the first week, follow by a 3-week non-treatment interval. Outcomes are assessed as efficacy outcomes and safety outcomes. Efficacy outcomes include symptom (CCS score, NYHA classification, nitroglycerin dosage, SAQ questionnaire), exertional capacity (6MWT), quality of life (SF-36 questionnaire) and imaging evaluation (myocardial perfusion imaging and echocardiography). Safety outcome include the change of serum TNT, CKMB, BNP and adverse event (AE) occurrence. Symptom, 6MWT and questionnaires will be evaluated at baseline and 13th week, 6th months, 12th months of CSWT. Imaging outcomes will be evaluated at baseline and 13th week, 12th months of CSWT. The level of TNT, CKMB and BNP will be tested before and 1st week after initiation of CSWT.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's planned enrollment of 60 is below the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Beijing Hospital is the lead sponsor of 51 studies on the registry; 22 are open to participants now.
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Severe CAD patients were enrolled and coronary angiography indicated complicated severe lesions. Although they were under OMT, stress myocardial perfusion imaging (MPI) showed obvious ischemia. They were not candidate for coronary revascularization.
Exclusion Criteria:
The treatment group will receive cardiac shock wave therapy. The CSWT entire treatment will period last 3 months with 9 sessions. CSWT will administered in the first week, followed by a 3-week non-treatment interval.
Device: cardiac shock wave therapy
Two target segments of left ventricle will be chosen for all participants. In each target segment, 9 sties will be administered with 200 shots at each site. Low-intensity SW (200 impulses/spot; energy flux 0.09 mJ/mm2), will be administered under electrocardiographic R-wave gating. The entire treatment period will last 3 months with 9 sessions. CSWT will be administered in the first week, followed by a 3-week non-treatment interval.
Summed Rest Score
Summed Rest Score of 17 segments of left ventricle under myocardial perfusion imaging. Each segment will be scored from 0 to 4. The minimum score is 0 while the maximum score is 68. Higher score means worse ischemia.
Time frame: Change from Baseline Summed Rest Score at 12 months.
Summed Stress Score
Summed Stress Score of 17 segments of left ventricle under myocardial perfusion imaging. Each segment will be scored from 0 to 4. The minimum score is 0 while the maximum score is 51. Higher score means worse ischemia.
Time frame: Change from Baseline Summed Stress Score at 12 months.
Summed Reverse Score
Summed Reverse Score of 17 segments of left ventricle under myocardial perfusion imaging. Each segment will be scored from 0 to 4. The minimum score is 0 while the maximum score is 51. Higher score means worse ischemia.
Time frame: Change from Baseline Summed Reverse Score at 12 months.
Regional Rest Score
Rest Score of target treatment segments of left ventricle under myocardial perfusion imaging. Each segment will be scored from 0 to 4. The minimum score is 0 while the maximum score is 8. Higher score means worse ischemia.
Time frame: Change from Baseline Regional Rest Score at 12 months.
Regional Stress Score
Stress Score of target treatment segments of left ventricle under myocardial perfusion imaging will be calculate. Each segment will be scored from 0 to 4. The minimum score is 0 while the maximum score is 8. Higher score means worse ischemia.
Time frame: Change from Baseline Regional Stress Score at 12 months.
Regional Reverse Score
Reverse Score of target treatment segments of left ventricle under myocardial perfusion imaging will be calculate. Each segment will be scored from 0 to 4. The minimum score is 0 while the maximum score is 8. Higher score means worse ischemia.
Time frame: Change from Baseline Regional Reverse Score at 12 months.
CCS score
Canadian Cardiovascular Society score. The score is from 1 to 4 score. Higher score means worse ischemia.
Time frame: Change from Baseline CCS score at 12 months.
NYHA classification
Now York Heart Association classification. The score is from 1 to 4. Higher score means worse heart function.
Time frame: Change from Baseline NYHA classification at 12 months.
Seattle Angina Questionnaire
Seattle Angina Questionnaire has five domain: physical limitation, angina stability, angina frequency, treatment satisfaction and quality of life. Each domain are 0-100 scale.
Time frame: Change from Baseline NYHA classification at 12 months.
QOL: SF-36 Questionnaire
SF-36 Questionnaire include vitality, physical functioning, body pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health. Each items are 0-100 scale.
Time frame: Change from Baseline SF-36 score at 12 months.
Six minutes walk test
Six minutes walk test proceed according to ATS guideline. The total distance will be recored.
Time frame: Change from Baseline 6MWT at 12 months.
Left ventricular ejection fraction
Left ventricular ejection fraction on echocardiography
Time frame: Change from Baseline status at 12 months
Cardiac enzyme
Serum Troponin T, CKMB
Time frame: Change from Baseline status at 13th week after treatment.
Brain Natrium Peptide
Serum brain Natrium Peptide
Time frame: Change from Baseline status at 13th week after treatment.
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Beijing Hospital