The Minimally Invasive Coronary Surgery Compared to STernotomy Coronary Artery Bypass Grafting Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 176
- 试验地点
- 25
- 主要终点
- Quality of life - physical function
研究概览
简要总结
MICS CABG (Minimally invasive coronary surgery), where coronary artery bypass grafting (CABG) is completed through a small incision over the left chest, has evolved to become a safe and less invasive alternative to conventional sternotomy CABG. Several observational studies have suggested significantly shorter time to return to physical activity for MICS CABG patients compared to sternotomy CABG patients. A randomized study is warranted to validate these findings, provide higher level of evidence, and potentially lead to changes in practice. The MIST Trial is a multi-centre, prospective, open label, randomized control trial comparing quality of life and recovery in the early post-operative period, between patients undergoing MICS CABG versus patients undergoing sternotomy CABG. Patients referred for isolated CABG for multi-vessel coronary artery disease and deemed technically suitable for sternotomy CABG as well as for MICS CABG are considered for enrollment into the trial. Quality of life questionnaires (The SF-36, Seattle Angina Questionnaire and EQ-5D-5L) will be used to assess the quality of life and recovery in patients undergoing sternotomy CABG or MICS CABG at 1 month, 3 months, 6 months and 12 months follow up.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Angiographically-confirmed multi-vessel coronary artery disease lesions with >=70% in at least 2 major epicardial vessels in 2 or more coronary artery territories (left anterior descending (LAD), circumflex (CX) and right coronary artery (RCA)) OR lesions >=50% in the left main (LM)
- •Patients who, in the opinion of the investigator, are amenable for coronary surgery through either median sternotomy or minimally-invasive approach.
- •Patients who are willing and able to comply with all follow-up study visits.
排除标准
- •<18 years of age
- •concomitant cardiac procedure with CABG (e.g. valve repair or replacement)
- •Previous cardiac surgery, mediastinal irradiation, or significant trauma to the chest
- •Contra-indications for MICS CABG, including: severe pectus excavatum; severe pulmonary disease; hemodynamically significant left subclavian stenosis; morbid obesity; severe left ventricular (LV) dysfunction; no adequate PDA or marginal branch target; absence of femoral pulse bilaterally.
- •Contraindications for conventional CABG via sternotomy
- •Concomitant life-threatening disease likely to limit life expectancy to <2 years
- •Emergency CABG with hemodynamic compromise
- •Inability to provide informed consent.
研究组 & 干预措施
CABG with sternotomy
Patients in this group will undergo coronary artery bypass grafting (CABG) in the usual way, through an incision in the middle of the chest, through the breastbone or sternum (conventional CABG).
干预措施: Conventional CABG (Procedure)
Minimally-invasive CABG
Patients in this group will undergo coronary artery bypass grafting (CABG) using a minimally-invasive approach (MICS CABG), through smaller incisions between the ribs.
干预措施: MICS CABG (Procedure)
结局指标
主要结局
Quality of life - physical function
时间窗: 4 weeks after surgery
Comparison of the physical quality of life between the two groups four weeks after surgery using the physical function score of the 36-Item Short Form Health Survey (SF-36). The physical function score is a scale from 0 (poor physical function) to 100 (excellent physical function, with an average score of 50. It includes items that assess physical functioning, bodily pain, physical role functioning, vitality, and generaly health perceptions.
次要结局
- Post-operative transfusion(From the time of surgery until the patient is discharged from hospital, an average of 7 days)
- Length of ICU stay(From the time of surgery until the patient is discharged from hospital, an average of 7 days)
- Major Adverse Cardiac and Cerebrovascular Events (MACCE) and Target Vessel Revascularization (TVR)(Through study completion, an average of 1 year after surgery.)
- Duration of intubation(Measured from the time of arrival in the Intensive Care Unit until the time patients are extubated, an average of 12 hours.)
- Length of hospital stay(From the time of surgery until the patient is discharged from hospital, an average of 7 days)
- Quality of Life - mental function(4 weeks after surgery)
- Wound infection(During the first 2 months after surgery)
- Re-exploration for bleeding(From the time of surgery until the patient is discharged from hospital, an average of 7 days)
- Post-operative pain(From the time of surgery until the patient is discharged from hospital, an average of 7 days)
- Atrial fibrillation(From the time of surgery until the patient is discharged from hospital, an average of 7 days)
- Angina(4 weeks after surgery)
- Number of bypass grafts(During coronary artery bypass surgery)
- Percentage of arterial grafts(During coronary artery bypass surgery)
- Intra-operative transfusion(During coronary artery bypass surgery)