Clinical Trials Logo

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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT03235323
Study type Interventional
Source First Affiliated Hospital, Sun Yat-Sen University
Contact Mengya Liang, Dr
Phone +8613560172190
Email infisdsums@gmail.com
Status Recruiting
Phase N/A
Start date September 5, 2017
Completion date August 7, 2021

See also
  Status Clinical Trial Phase
Completed NCT05036044 - Stroke and Carotid-Cerebral Vascular Disease After CABG
Recruiting NCT05010460 - Study of Roxadustat for Reducing the Incidence of Acute Kidney Injury After Coronary Artery Bypass Grafting Phase 2
Completed NCT03622671 - Fibrin Clot Properties and Blood Loss Following Coronary Artery By-pass Grafting N/A
Completed NCT00400790 - Organ Protection for Coronary Artery Bypass Graft (CABG): Propofol Versus Desflurane N/A
Not yet recruiting NCT03275220 - Assessment Of Right Ventricular Function In Patients Undergoing Coronary Artery Bypass Graft In Assiut University N/A
Completed NCT01256372 - An Trial of Two Dosing Regimens of AP214 for the Prevention of Kidney Injury in Patients Undergoing Cardiac Surgery Phase 2
Completed NCT00489827 - Glutamate for Metabolic Intervention in Coronary Surgery Phase 3
Completed NCT04591119 - Transversus Thoracis Muscle Plane Block for Postoperative Pain in Adult Cardiac Surgery N/A
Active, not recruiting NCT03908593 - Proton Pump Inhibitor Preventing Upper Gastrointestinal Injury In Patients On Dual Antiplatelet Therapy After CABG Phase 4
Recruiting NCT03774342 - The Influence of Cognitive Decline on Quality of Life After Coronary Bypass
Enrolling by invitation NCT03999398 - Short and Long-term Results of PCI in no Touch Vein-graft.
Recruiting NCT05414331 - WithDRawal Impact Of Postoperative Beta-Blocker N/A
Completed NCT02981680 - Effect of Remote Ischemic Preconditioning on the Incidence of Acute Kidney Injury in Patients Undergoing Coronary Artery Bypass Graft Surgery N/A
Completed NCT00600704 - Impact of Fluid Restriction Policy in Reducing the Use of Red Cells in Cardiac Surgery N/A
Completed NCT06013605 - Effect of Walking Exercise on Functional Capacity and Productivity in Patients After Coronary Artery Bypass Graft N/A
Active, not recruiting NCT02731794 - On-pump Beating Coronary Artery Bypass Grafting by Ventricular Assist Phase 4
Completed NCT02722213 - Mindfulness & Stress Management Study for Cardiac Patients N/A
Completed NCT01285271 - A Pre- and Post- Coronary Artery Bypass Graft Implantation Disposed Application of Xenon Phase 3
Completed NCT00823082 - Use of Antithrombin in Cardiac Surgery With Cardiopulmonary Bypass Phase 2
Completed NCT00911976 - Study of the Xience V Everolimus-eluting Stent in Saphenous Vein Graft Lesions Phase 4