A Partially Randomized Patient Preference Trial to Assess the Quality of Life and Patency Rate After Minimally Invasive Cardiac Surgery-Coronary Artery Bypass Grafting: the MICS-CABG PRPP Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 248
- 试验地点
- 2
- 主要终点
- SF-36 PCS score (Physical component summary of medical outcomes study-short form 36-item scores) at 30 days (1month) after surgery
研究概览
简要总结
This trial will address essential questions of the efficacy and safety of MICS-CABG in addition to the quality of life and patency rate of the grafts. The study will also address the impact of patients' preferences on external validity and internal validity. In this study, patients with a preference will be allocated to treatment strategies accordingly, whereas only those patients without a distinct preference will be randomized. The randomized trial is a 248-patient controlled, randomized, investigator-blinded trial. It is designed to compare whether treatment with MICS-CABG is beneficial in comparison to CABG. This study is aimed to establish the superiority hypothesis for the physical component summary (PCS) accompanied by the noninferiority hypothesis for overall graft patency. Patients with no treatment preference will be randomized in a 1:1 fashion to one of the two treatment arms. The primary efficacy endpoints are the PCS score at 30 days (1 month) after surgery and the overall patency rate of the grafts within 14 days ( before discharge) after surgery. Secondary outcome measures include the PCS score and patency rate at different time points. Safety endpoints include major adverse cardiac and cerebrovascular events, complications, bleeding, wound infection, death, etc.
详细描述
Objective and Hypothesis: The aim of this study is to investigate and compare the mid-term safety and efficacy end-points (SF-36 PCS at 30 days after surgery, etc.) in patients with complex coronary artery lesions (an indication of OPCAGB) who received MICS-CABG and those who received thoracotomy OPCABG. The investigators hypothesize that patients in MICS-CABG group have superior 1-month PCS score assessed by SF-36 post-surgery and noninferior postprocedural angiographic graft patency rate prior to discharge.
Intervention Methods:
-
MICS-CABG (experimental group): Off-pump multi-vessel coronary artery bypass grafting via left thoracotomy under minimally invasive conditions.
-
Surgery preparation:
General anesthesia, double lumen tracheal intubation. In the supine position, tilt 15° to the right. An automatic defibrillation electrode is attached to the right front and left rear chest wall, and the external defibrillator is connected. A small incision of 8-10 cm into the left anterior lateral 5th intercostal space was performed into the chest. 2. Internal mammary artery acquisition:
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
- None
入排标准
- 年龄范围
- 25 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(A patient will be included in the study when the following criteria and requirements are met)
- •① Patient age of ≥25 years but ≤85 years, and patients with CAD who require multivessel coronary bypass surgery. ② Angina that affects daily life and work and is uncontrollable with conservative treatment. ③ Significant stenosis in the left main (LM) coronary artery, left anterior descending (LAD) branch or left circumflex (LCX) branch >70%. ④ Severe stenosis (stenosis degree >70%) of three main branches of the coronary artery (anterior descending branch, circumflex branch, right coronary artery) with the need to undergo off-pump coronary artery bypass surgery.
排除标准
- •Unstable preoperative hemodynamic status requiring emergency surgery
- •Severe emphysema, hypoxemia [post-bronchodilator forced expiratory volume in 1 s (FEV1)/forced vital capacity (FVC)<70% and FEV1%predicted<50% or partial pressure of oxygen (pO2)<60 mmHg or partial pressure of carbon dioxide (pCO2)>40 mmHg without oxygen therapy]
- •Old large area myocardial infarction, no viable myocardium based on isotope and echocardiography examination, significant cardiac enlargement, cardiothoracic ratio>0.75, EF<30%, left ventricular diastolic diameter (LVDd)>60 mm, left ventricular aneurysm or severe arrhythmia, prone to experience unstable preoperative hemodynamic status during surgery
- •Severe pleural adhesion, chest deformity, or previous thoracic radiotherapy
- •Previous open heart surgery
- •Simultaneous valve or other cardiac surgery
- •Planned cardiopulmonary bypass surgery
- •Poor condition of myocardial infarction (MI), extensive lesion, distal or entire diffuse stenosis, or inability to match lumen due to small diameter (<1.0 mm) or severe calcification
- •Others: Terminal cancer, uncontrolled infection, bleeding, progressive degenerative systemic disease, severe brain injury, multiple organ failure and other major organ dysfunction such as severe liver dysfunction, severe heart failure or cardiogenic shock, intolerance to surgery, and other contraindications of CABG
研究组 & 干预措施
MICS-CABG (minithoractomy CABG)
Patients undergoing MICS-CABG(minithoractomy CABG)
干预措施: Minimal invasive coronary surgery (Procedure)
CABG (sterotomy CABG)
Patients undergoing CABG (sterotomy CABG)
干预措施: Off-pump coronary artery bypass surgery (Procedure)
结局指标
主要结局
SF-36 PCS score (Physical component summary of medical outcomes study-short form 36-item scores) at 30 days (1month) after surgery
时间窗: 30 days (1 month) after surgery
The SF-36 is a concise health test that features Physical Functioning (PF), Roe-Physical (RP), Bodily Pain, General Health (GH), Vitality (VT), Social Functioning (SF), Roe-Emotional (Emotional) and Mental Health (MH) functioning and comprehensively summarizes the quality of life of the respondents across 8 aspects. The PCS and mental component summary (MCS) can be calculated from the eight abovementioned indicators with different weights. The PCS and the MCS each range from 0 to 50, with a lower score indicating worse quality of life (QoL) and a higher score indicating better QoL.
Overall patency rate of the grafts
时间窗: within 14 days after surgery (before discharge)
the patency rates of the LIMA, RIMA, saphenous vein graft (SVG) and radial artery (RA) will be evaluated by the Fitzgibbon A+B grade
次要结局
- Perioperative transfusion volume(Intraoperative and 14 days after surgery)
- Incidence of cardiopulmonary bypass conversion(14 days after surgery)
- Percentage of intra-aortic balloon pump (IABP) and extracorporeal membrane oxygenation (ECMO) usage(14 days after surgery)
- Incidence of secondary surgery(14 days after surgery)
- Incidence of adverse events of wound healing(14 days, 1 month, 3 months, 6 months and 12 months after surgery)
- Incidence of perioperative major adverse cardiovascular and cerebrovascular event (MACCE)(30 days after surgery)
- Incidence of atrial fibrillation(30 days after surgery)
- Incidence of renal failure(30 days after surgery)
- Incidence of re-intubation(14 days after surgery)
- Length of stay after surgery (days)(14 days after surgery)
- Intensive care unit (ICU) duration after surgery (hours)(14 days after surgery)
- Duration of mechanical ventilation application (hours)(14 days after surgery)
- Physical limitation score of Seattle angina questionnaire (SAQ)(1 month, 3 months, 6 months and 12 months after surgery)
- Angina stability score of Seattle angina questionnaire (SAQ)(1 month, 3 months, 6 months and 12 months after surgery)
- Angina frequency score of Seattle angina questionnaire (SAQ)(1 month, 3 months, 6 months and 12 months after surgery)
- Treatment satisfaction score of Seattle angina questionnaire (SAQ)(1 month, 3 months, 6 months and 12 months after surgery)
- Disease perception score of Seattle angina questionnaire (SAQ)(1 month, 3 months, 6 months and 12 months after surgery)
- Incidence of readmission due to myocardial infarction (MI)(1 month, 3 months, 6 months and 12 months after surgery)
- Incidence of readmission due to heart failure(1 month, 3 months, 6 months and 12 months after surgery)
- Percentage of mid-term graft patency (evaluated by CT or angiography)(12 months after surgery)
- Intrahospital RBC transfusion volume(before discharge)
- SF-36 PCS scores(7-14 days (0.5 month) , 3 months, 6 months and 1 year after surgery)
- Incidence of readmission due to myocardial infarction (MI)(1 month, 3 months, 6 months and 12 months after surgery)
- Incidence of renal failure(30 days after surgery)
- Bypass surgical variation index(within 7 days after surgery)
- Angina stability score of Seattle angina questionnaire (SAQ)(1 month, 3 months, 6 months and 12 months after surgery)
- Incidence of cardiopulmonary bypass conversion(14 days after surgery)
- Incidence of adverse events of wound healing(14 days, 1 month, 3 months, 6 months and 12 months after surgery)
- Incidence of perioperative major adverse cardiovascular and cerebrovascular event (MACCE)(30 days after surgery)
- Incidence of re-intubation(14 days after surgery)
- Intensive care unit (ICU) duration after surgery (hours)(14 days after surgery)
- Perioperative transfusion volume(Intraoperative and 14 days after surgery)
- Percentage of intra-aortic balloon pump (IABP) and extracorporeal membrane oxygenation (ECMO) usage(14 days after surgery)
- Incidence of secondary surgery(14 days after surgery)
- Incidence of atrial fibrillation(30 days after surgery)
- Length of stay after surgery (days)(14 days after surgery)
- Duration of mechanical ventilation application (hours)(14 days after surgery)
- Disease perception score of Seattle angina questionnaire (SAQ)(1 month, 3 months, 6 months and 12 months after surgery)
- Incidence of readmission due to heart failure(1 month, 3 months, 6 months and 12 months after surgery)
- Percentage of mid-term graft patency (evaluated by CT or angiography)(12 months after surgery)
- SF-36 MCS scores(7-14 days, 1month, 3 months, 6 months and 1 year after surgery)
- Physical limitation score of Seattle angina questionnaire (SAQ)(1 month, 3 months, 6 months and 12 months after surgery)
- Angina frequency score of Seattle angina questionnaire (SAQ)(1 month, 3 months, 6 months and 12 months after surgery)
- Treatment satisfaction score of Seattle angina questionnaire (SAQ)(1 month, 3 months, 6 months and 12 months after surgery)
- Time to the first major adverse cardiovascular and cerebrovascular event (MACCE) after surgery(1 month, 3 months, 6 months, 12 months, 36months and 60 months after surgery)
- Patency rate of the different material grafts(14 days (before discharge) and 1 year after surgery)
- Number of Participants with re-exploration for bleeding or other causes (not including wound-related causes)(within 1 year after surgery)
- Wound infection rate(within 3 months after surgery)