Coronary Artery Bypass Clinical Trial
— SEECABGOfficial title:
Study of Efficacy of External CounterPulsation on Reducing the Prevalence of Vein Graft Failure and Improving Cardiac Function for Postoperative Coronary Artery Bypass Grafting Patients
The aim of this study is to evaluate the effect of External CounterPulsation on postoperative heart function and vein graft failure rates of coronary artery bypass grafting patients.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | August 7, 2021 |
Est. primary completion date | August 7, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: - Patients underwent coronary artery bypass grafting surgery Exclusion Criteria: - Cerebral hemorrhage within six months; - Obvious aortic insufficiency; - Aortic aneurysm; - Aortic dissection; - Coronary fistula or severe coronary aneurysm; - Symptomatic Congestive heart failure - New York Heart Association(NYHA)heart function class IV - Valvular heart disease; - Congenital heart diseases; - Cardiomyopathies - Uncontrolled hypertension, defined as SBP=180mmHg or DBP=110mmHg; - Lower limb infection; - Deep venous thrombosis; - Progressive malignancies |
Country | Name | City | State |
---|---|---|---|
China | Department of cardiac surgery, The first affiliated hospital of Sun Yat-sen university | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Mengya Liang |
China,
Zhang Y, He X, Chen X, Ma H, Liu D, Luo J, Du Z, Jin Y, Xiong Y, He J, Fang D, Wang K, Lawson WE, Hui JC, Zheng Z, Wu G. Enhanced external counterpulsation inhibits intimal hyperplasia by modifying shear stress responsive gene expression in hypercholesterolemic pigs. Circulation. 2007 Jul 31;116(5):526-34. Epub 2007 Jul 9. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 2-year vein graft patency rate | 2-year vein graft patency rate determined by coronary CT angiography | Two years postoperatively | |
Primary | 2-year major composite cardiovascular events (MACEs) | 2-year major composite cardiovascular events,including STEMI/NSTEMI,readmission of heart attack, renal dialysis and acute heart failure | Two years postoperatively | |
Secondary | Canadian Cardiovascular Society (CCS) scoring | One and two years postoperatively | ||
Secondary | left ventricular end-systolic volume index (LVESVI) and Ejection Fraction | left ventricular end-systolic volume index (LVESVI) and Ejection Fraction by echocardiography | One and two years postoperatively |
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