微创冠状动脉手术与 STernotomy 冠状动脉旁路移植试验的比较 (MIST)
微创冠状动脉手术与 STernotomy 冠状动脉旁路移植术比较随机对照试验
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
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Jilin
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Jilin、Jilin、中国、130117
- Jilin Heart Hospital
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Ontario
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Ottawa、Ontario、加拿大、K1Y 4W7
- Division of Cardiac Surgery, University of Ottawa Heart Institute
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Toronto、Ontario、加拿大
- University Health Network
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Karnataka
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Bangalore、Karnataka、印度、560041
- Apollo Hospital, Bangalore
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National Capital Territory of Delhi
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New Delhi、National Capital Territory of Delhi、印度
- Manipal Hospitals
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Taipei
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Taipei、Taipei、台湾、220
- Far-Eastern Memorial Hospital
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Stuttgart、德国
- Robert-Bosch-Hospital
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Saxony
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Leipzig、Saxony、德国
- Leipzig Heart Institute GmbH
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Singapore、新加坡
- National University Hospital (NUH) - Singapore
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Chiba
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Urayasu、Chiba、日本
- Tokyo Bay Urayasu Ichikawa Medical Center
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Leuven、比利时
- Universitaire Ziekenhuizen Leuven
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Pennsylvania
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Pittsburgh、Pennsylvania、美国、15213
- University of Pittsburgh Medical Center
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Wisconsin
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La Crosse、Wisconsin、美国、54601
- Gundersen Lutheran Medical Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
描述
纳入标准：
- 18岁或以上
- 经血管造影证实的多支冠状动脉疾病病变，在 2 个或更多冠状动脉区域（左前降支 (LAD)、回旋支 (CX) 和右冠状动脉 (RCA)）中至少 2 个主要心外膜血管 >=70% 或左主干 (LM) 病变 >=50%
- 研究者认为适合通过正中胸骨切开术或微创方法进行冠状动脉手术的患者。
- 愿意并能够遵守所有后续研究访问的患者。
排除标准：
- 伴随 CABG 的心脏手术（例如 阀门维修或更换）
- 既往心脏手术、纵隔放疗或胸部严重外伤
- MICS CABG 的禁忌症，包括：严重的漏斗胸；严重的肺部疾病；血流动力学显着的左锁骨下狭窄；病态肥胖;严重的左心室 (LV) 功能障碍；没有足够的 PDA 或边缘分支目标；双侧股动脉无搏动。
- 经胸骨切开术进行常规 CABG 的禁忌症
- 伴随的危及生命的疾病可能会限制预期寿命
- 血流动力学受损的紧急 CABG
- 无法提供知情同意。
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器：CABG 胸骨切开术
该组患者将以常规方式通过胸骨或胸骨的切口（常规 CABG）进行冠状动脉旁路移植术 (CABG)。
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通过胸骨或胸骨的切口进行冠状动脉旁路移植术。
其他名称：
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实验性的：微创CABG
该组患者将使用微创方法 (MICS CABG) 通过肋骨之间的较小切口进行冠状动脉旁路移植术 (CABG)。
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通过肋骨之间的小切口进行冠状动脉旁路移植术。
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Quality of life - physical function
大体时间：Surgery to 4 weeks post-op
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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 generally health perceptions. Analysis restricted to high-volume recruiting centers (>10 patients through study). |
Surgery to 4 weeks post-op
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Major Adverse Cardiac and Cerebrovascular Events (MACCE) and Target Vessel Revascularization (TVR)
大体时间：Surgery to study completion (average of 1 year after surgery.)
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A composite endpoint of mortality, peri-operative myocardial infarction, non-peri-operative myocardial infarction, stroke, and new CABG or PCI associated with documented ischemia. Analysis restricted to high-volume recruiting centers (>10 patients through study). |
Surgery to study completion (average of 1 year after surgery.)
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Number of bypass grafts
大体时间：During coronary artery bypass surgery
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A comparison of the mean number of bypass grafts performed between the two groups Analysis restricted to high-volume recruiting centers (>10 patients through study).
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During coronary artery bypass surgery
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Percentage of arterial grafts
大体时间：During coronary artery bypass surgery
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A comparison of the percentage of bypass grafts that are arterial between the groups. Analysis restricted to high-volume recruiting centers (>10 patients through study). |
During coronary artery bypass surgery
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Intra-operative transfusion
大体时间：During coronary artery bypass surgery
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A comparison of the number of transfusions during surgery between the groups Analysis restricted to high-volume recruiting centers (>10 patients through study).
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During coronary artery bypass surgery
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Post-operative transfusion
大体时间：Surgery to hospital discharge (average of 7 days)
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A comparison of the number of transfusions after surgery between the groups Analysis restricted to high-volume recruiting centers (>10 patients through study).
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Surgery to hospital discharge (average of 7 days)
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Re-exploration for bleeding
大体时间：Surgery to hospital discharge (average of 7 days)
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The incidence of re-exploration for bleeding after surgery Analysis restricted to high-volume recruiting centers (>10 patients through study).
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Surgery to hospital discharge (average of 7 days)
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Post-operative pain
大体时间：Surgery to hospital discharge (average of 7 days)
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Measurement of patient's subjective assessment of their pain after surgery using a visual analog scale Analysis restricted to high-volume recruiting centers (>10 patients through study).
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Surgery to hospital discharge (average of 7 days)
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Duration of intubation
大体时间：Time of arrival in the Intensive Care Unit until extubation. (average of 12 hours.)
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Comparison of the average duration of intubation between groups Analysis restricted to high-volume recruiting centers (>10 patients through study).
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Time of arrival in the Intensive Care Unit until extubation. (average of 12 hours.)
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Length of ICU stay
大体时间：Surgery to hospital discharge (average of 7 days)
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Comparison of the average number of days spent in Intensive Care Unit between groups Analysis restricted to high-volume recruiting centers (>10 patients through study).
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Surgery to hospital discharge (average of 7 days)
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Length of hospital stay
大体时间：Surgery to hospital discharge (average of 7 days)
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Comparison of the average number of days spent in hospital between groups Analysis restricted to high-volume recruiting centers (>10 patients through study).
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Surgery to hospital discharge (average of 7 days)
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Atrial fibrillation
大体时间：Surgery to hospital discharge (average of 7 days)
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Incidence of new-onset atrial fibrillation after cardiac surgery Analysis restricted to high-volume recruiting centers (>10 patients through study).
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Surgery to hospital discharge (average of 7 days)
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Wound infection
大体时间：Surgery to 2-months post-op
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Incidence of wound infections in each group Analysis restricted to high-volume recruiting centers (>10 patients through study).
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Surgery to 2-months post-op
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Angina
大体时间：Surgery to 4-weeks post-op
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Prevalence of anginal symptoms, as measured by the Seattle Angina Questionnaire. The SAQ includes scales that measure physical limitation, stability of angina, frequency of angina, satisfaction with treatment, and perception of disease, each of which is measured on a scale of 0 to 100 where higher scores indicate better function or health. Analysis restricted to high-volume recruiting centers (>10 patients through study). |
Surgery to 4-weeks post-op
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Quality of Life - mental function
大体时间：Surgery to 4-weeks post-op
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Comparison of the mental quality of life between the two groups four weeks after surgery using the mental component score of the 36-Item Short Form Health Survey (SF-36). The mental function score is a scale from 0 (poor mental quality of life) to 100 (excellent mental quality of life), with an average score of 50. It includes items that assess vitality, general health perceptions, emotional role functioning, social role functioning, and mental health. Analysis restricted to high-volume recruiting centers (>10 patients through study). |
Surgery to 4-weeks post-op
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合作者和调查者
合作者
调查人员
- 首席研究员：Marc Ruel, MD、Ottawa Heart Institute Research Corporation
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
常规CABG的临床试验
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Pinnacle Health Cardiovascular Institute完全的
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Beijing Anzhen HospitalBeijing Municipal Science & Technology Commission未知
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St. Petersburg State Pavlov Medical University完全的
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Diagram B.V.招聘中
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St. Petersburg State Pavlov Medical University招聘中