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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03235323
Other study ID # LS2017-144
Secondary ID
Status Recruiting
Phase N/A
First received July 28, 2017
Last updated September 4, 2017
Start date September 5, 2017
Est. completion date August 7, 2021

Study information

Verified date September 2017
Source First Affiliated Hospital, Sun Yat-Sen University
Contact Mengya Liang, Dr
Phone +8613560172190
Email infisdsums@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

Coronary artery disease (CAD) is prevalent worldwide and the leading cause of mortality of citizens. Coronary Artery Bypass Grafting (CABG)is one of the major revascularization procedures for multi-vessel disease nowadays. However vein graft failures (VGF) are known to occur frequently following CABG surgery . It is estimated that VGF developed in 25% patients in half a year postoperatively, and up to 50% vein grafts would result in occlusion in ten years postoperatively. Surgical success depends on the continued patency of grafts, and VGF has been associated with worse outcomes in CABG patients. Thus prevention of VGF following CABG is an active area of scientific inquiry. External counter pulsation (ECP) is a non-invasive method which consists of three sets of pneumatic cuffs attached to each of the patient's legs at the calf and lower and upper thigh. The inflation of the cuffs is triggered by a computer, and timing of the inflation is based on the R wave of the electrocardiogram. The ECP therapist adjusts the inflation and deflation timing to provide optimal blood movement per a finger plethysmogram waveform reading. This produces a retrograde flow of blood in the aorta resulting in a diastolic augmentation of blood flow and also an increase in venous return, which leads to an improved coronary perfusion pressure during diastole.ECP has been elucidated that it may release angina symptoms and improve the prognosis of CAD, however, it remained unknown that weather EECP can reduce VGF rates following CABG surgery. The aim of this study is to evaluate the effect of ECP on heart function of CABG patients and VGF rates.

To address this investigation, patients underwent CABG with at least one vein graft are enrolled and randomize them into control or ECP group, the ECP intervention will be carried out with a standard protocol which involves 35 one-hour sessions (5 days a week) for continuous 7 weeks, and the follow-up will last for 2 years. The primary endpoints are the 2-year major composite cardiovascular events (MACEs,) and 2-year vein graft patency rate determined by coronary CT angiography, secondary endpoints include scoring of angina pectoris, heart function by echocardiography, biomarkers of arteriosclerosis and endothelial function.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
External Counterpulsation
ECP is a non-invasive method which consists of three sets of pneumatic cuffs attached to each of the patient's legs at the calf and lower and upper thigh. The inflation of the cuffs is triggered by a computer, and timing of the inflation is based on the R wave of the electrocardiogram. The ECP therapist adjusts the inflation and deflation timing to provide optimal blood movement per a finger plethysmogram waveform reading. This produces a retrograde flow of blood in the aorta resulting in a diastolic augmentation of blood flow and also an increase in venous return, which leads to an improved coronary perfusion pressure during diastole.

Locations

Country Name City State
China Department of cardiac surgery, The first affiliated hospital of Sun Yat-sen university Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Mengya Liang

Country where clinical trial is conducted

China, 

References & Publications (1)

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

Outcome

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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