Efficacy of External CounterPulsation for Postoperative Coronary Artery Bypass Grafting Patients

NCT03235323 | Unknown

• 1 other identifier: LS2017-144
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Counterpulsation; Coronary Artery Bypass

Keywords

Vein Graft Failure; Coronary Artery Bypass; External Counterpulsation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Canadian Cardiovascular Society （CCS） scoring

  One and two years postoperatively

• left ventricular end-systolic volume index (LVESVI) and Ejection Fraction

  One and two years postoperatively

Study Arms (2)

ECP group

EXPERIMENTAL

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

Control group

NO INTERVENTION

Patients of Control group received routine medicine treatment postoperatively

Interventions

External Counterpulsation DEVICE

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 group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients underwent coronary artery bypass grafting surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Mengya Liang: lead

Study Sites (1)

Department of cardiac surgery, The first affiliated hospital of Sun Yat-sen university

Guangzhou, Guangdong, 510080, China

RECRUITING

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

  PMID: 17620513 BACKGROUND

MeSH Terms

Interventions

Counterpulsation

Intervention Hierarchy (Ancestors)

Assisted Circulation; Surgical Procedures, Operative

Study Officials

• Zhongkai Wu

  Department of Cardiovascular Medcine

  STUDY DIRECTOR

Central Study Contacts

Mengya Liang, Dr

CONTACT

+8613560172190; infisdsums@gmail.com

Yan Zhang, Dr

CONTACT

+8618902233602

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 28, 2017
• First Posted: August 1, 2017
• Study Start: September 5, 2017
• Primary Completion: August 7, 2020
• Study Completion: August 7, 2021
• Last Updated: September 7, 2017

Record last verified: 2017-09

Locations

CN (1)