The Minimally Invasive Coronary Surgery Compared to STernotomy Coronary Artery Bypass Grafting Trial
- Conditions
- Coronary Artery Disease
- Interventions
- Procedure: MICS CABGProcedure: Conventional CABG
- Registration Number
- NCT03447938
- Lead Sponsor
- Ottawa Heart Institute Research Corporation
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 176
- 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.
- <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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Minimally-invasive CABG MICS 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. CABG with sternotomy Conventional CABG 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).
- Primary Outcome Measures
Name Time Method Quality of life - physical function 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.
- Secondary Outcome Measures
Name Time Method Re-exploration for bleeding From the time of surgery until the patient is discharged from hospital, an average of 7 days The incidence of re-exploration for bleeding after surgery
Post-operative pain From the time of surgery until the patient is discharged from hospital, an average of 7 days Measurement of patient's subjective assessment of their pain after surgery using a visual analog scale
Number of bypass grafts During coronary artery bypass surgery A comparison of the mean number of bypass grafts performed between the two groups
Post-operative transfusion From the time of surgery until the patient is discharged from hospital, an average of 7 days A comparison of the number of transfusions after surgery between the groups
Percentage of arterial grafts During coronary artery bypass surgery A comparison of the percentage of bypass grafts that are arterial between the groups
Length of ICU stay From the time of surgery until the patient is discharged from hospital, an average of 7 days Comparison of the average number of days spent in Intensive Care Unit between groups
Major Adverse Cardiac and Cerebrovascular Events (MACCE) and Target Vessel Revascularization (TVR) Through study completion, an average of 1 year after surgery. A composite endpoint of mortality, peri-operative myocardial infarction, non-peri-operative myocardial infarction, stroke, and new CABG or PCI associated with documented ischemia.
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. Comparison of the average duration of intubation between groups
Length of hospital stay From the time of surgery until the patient is discharged from hospital, an average of 7 days Comparison of the average number of days spent in hospital between groups
Quality of Life - mental function 4 weeks after surgery 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.
Wound infection During the first 2 months after surgery Incidence of wound infections in each group
Intra-operative transfusion During coronary artery bypass surgery A comparison of the number of transfusions during surgery between the groups
Atrial fibrillation From the time of surgery until the patient is discharged from hospital, an average of 7 days Incidence of new-onset atrial fibrillation after cardiac surgery
Angina 4 weeks after surgery 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.
Trial Locations
- Locations (13)
Jilin Heart Hospital
🇨🇳Jilin, Jilin, China
Gundersen Lutheran Medical Center
🇺🇸La Crosse, Wisconsin, United States
Robert-Bosch-Hospital
🇩🇪Stuttgart, Germany
Universitaire Ziekenhuizen Leuven
🇧🇪Leuven, Belgium
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Division of Cardiac Surgery, University of Ottawa Heart Institute
🇨🇦Ottawa, Ontario, Canada
Tokyo Bay Urayasu Ichikawa Medical Center
🇯🇵Urayasu, Chiba, Japan
Manipal Hospitals
🇮🇳New Delhi, Delhi, India
University Health Network
🇨🇦Toronto, Ontario, Canada
Apollo Hospital, Bangalore
🇮🇳Bangalore, Karnataka, India
National University Hospital (NUH) - Singapore
🇸🇬Singapore, Singapore
Leipzig Heart Institute GmbH
🇩🇪Leipzig, Saxony, Germany
Far-Eastern Memorial Hospital
🇨🇳Taipei, Taiwan