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Efficacy of External CounterPulsation for Postoperative Coronary Artery Bypass Grafting Patients

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03235323
Acronym
SEECABG
Enrollment
120
Registered
2017-08-01
Start date
2017-09-05
Completion date
2021-08-07
Last updated
2017-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Bypass, Counterpulsation

Keywords

Vein Graft Failure, Coronary Artery Bypass, External Counterpulsation

Brief 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.

Detailed 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.

Interventions

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.

Sponsors

Mengya Liang
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Intervention model description

A standard ECP protocol involves 35 one-hour sessions (once per day, 5 days a week) and continuous for 7 weeks. ECP 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
2-year vein graft patency rateTwo years postoperatively2-year vein graft patency rate determined by coronary CT angiography
2-year major composite cardiovascular events (MACEs)Two years postoperatively2-year major composite cardiovascular events,including STEMI/NSTEMI,readmission of heart attack, renal dialysis and acute heart failure

Secondary

MeasureTime frameDescription
Canadian Cardiovascular Society (CCS) scoringOne and two years postoperatively
left ventricular end-systolic volume index (LVESVI) and Ejection FractionOne and two years postoperativelyleft ventricular end-systolic volume index (LVESVI) and Ejection Fraction by echocardiography

Countries

China

Contacts

Primary ContactMengya Liang, Dr
infisdsums@gmail.com+8613560172190
Backup ContactYan Zhang, Dr
+8618902233602

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026