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临床试验/NCT03235323
NCT03235323Unknown不适用

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

Mengya Liang1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2017年9月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
120
试验地点
1
主要终点
2-year vein graft patency rate

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients underwent coronary artery bypass grafting surgery

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: External Counterpulsation (Device)

Control group

No Intervention

Patients of Control group received routine medicine treatment postoperatively

结局指标

主要结局

2-year vein graft patency rate

时间窗: Two years postoperatively

2-year vein graft patency rate determined by coronary CT angiography

2-year major composite cardiovascular events (MACEs)

时间窗: Two years postoperatively

2-year major composite cardiovascular events,including STEMI/NSTEMI,readmission of heart attack, renal dialysis and acute heart failure

次要结局

  • 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)

研究者

发起方
Mengya Liang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mengya Liang

Professor

First Affiliated Hospital, Sun Yat-Sen University

研究点 (1)

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