Efficacy of External CounterPulsation for Postoperative Coronary Artery Bypass Grafting Patients (SEECABG)

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Bypass; Counterpulsation
• Intervention / Treatment: Device: External Counterpulsation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Recruiting
      • Department of cardiac surgery, The first affiliated hospital of Sun Yat-sen university
      • Contact: Mengya Liang; Phone Number: +8613560172190; Email: infisdsums@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 86 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ECP group; Patients of ECP group are subjected to a standard ECP protocol one week postoperatively. 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.	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.
No Intervention: Control group; Patients of Control group received routine medicine treatment postoperatively

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
2-year vein graft patency rate	2-year vein graft patency rate determined by coronary CT angiography	Two years postoperatively
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Canadian Cardiovascular Society （CCS） scoring		One and two years postoperatively
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

Collaborators and Investigators

• Sponsor: Mengya Liang
• Investigators: Study Director: Zhongkai Wu, Department of Cardiovascular Medcine

Publications and helpful links

General Publications

• 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. doi: 10.1161/CIRCULATIONAHA.106.647248. Epub 2007 Jul 9.

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2017
• Primary Completion (Anticipated): August 7, 2020
• Study Completion (Anticipated): August 7, 2021

Study Registration Dates

• First Submitted: July 28, 2017
• First Submitted That Met QC Criteria: July 28, 2017
• First Posted (Actual): August 1, 2017

Study Record Updates

• Last Update Posted (Actual): September 7, 2017
• Last Update Submitted That Met QC Criteria: September 4, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: External Counterpulsation; Coronary Artery Bypass; Vein Graft Failure
• Other Study ID Numbers: LS2017-144

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No