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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
176
Coronary artery bypass grafting performed through small incisions between the ribs.
Coronary artery bypass grafting performed through an incision through the sternum or breastbone.
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States
Universitaire Ziekenhuizen Leuven
Leuven, Belgium
Division of Cardiac Surgery, University of Ottawa Heart Institute
Ottawa, Ontario, Canada
University Health Network
Toronto, Ontario, Canada
Jilin Heart Hospital
Jilin City, Jilin, China
Leipzig Heart Institute GmbH
Leipzig, Saxony, Germany
Robert-Bosch-Hospital
Stuttgart, Germany
Apollo Hospital, Bangalore
Bangalore, Karnataka, India
Manipal Hospitals
New Delhi, National Capital Territory of Delhi, India
...and 3 more locations
Quality of life - physical function
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).
Time frame: Surgery to 4 weeks post-op
Major Adverse Cardiac and Cerebrovascular Events (MACCE) and Target Vessel Revascularization (TVR)
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).
Time frame: Surgery to study completion (average of 1 year after surgery.)
Number of bypass grafts
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).
Time frame: During coronary artery bypass surgery
Percentage of arterial grafts
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).
Time frame: During coronary artery bypass surgery
Intra-operative transfusion
A comparison of the number of transfusions during surgery between the groups Analysis restricted to high-volume recruiting centers (\>10 patients through study).
Time frame: During coronary artery bypass surgery
Post-operative transfusion
A comparison of the number of transfusions after surgery between the groups Analysis restricted to high-volume recruiting centers (\>10 patients through study).
Time frame: Surgery to hospital discharge (average of 7 days)
Re-exploration for bleeding
The incidence of re-exploration for bleeding after surgery Analysis restricted to high-volume recruiting centers (\>10 patients through study).
Time frame: Surgery to hospital discharge (average of 7 days)
Post-operative pain
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).
Time frame: Surgery to hospital discharge (average of 7 days)
Duration of intubation
Comparison of the average duration of intubation between groups Analysis restricted to high-volume recruiting centers (\>10 patients through study).
Time frame: Time of arrival in the Intensive Care Unit until extubation. (average of 12 hours.)
Length of ICU stay
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).
Time frame: Surgery to hospital discharge (average of 7 days)
Length of hospital stay
Comparison of the average number of days spent in hospital between groups Analysis restricted to high-volume recruiting centers (\>10 patients through study).
Time frame: Surgery to hospital discharge (average of 7 days)
Atrial fibrillation
Incidence of new-onset atrial fibrillation after cardiac surgery Analysis restricted to high-volume recruiting centers (\>10 patients through study).
Time frame: Surgery to hospital discharge (average of 7 days)
Wound infection
Incidence of wound infections in each group Analysis restricted to high-volume recruiting centers (\>10 patients through study).
Time frame: Surgery to 2-months post-op
Angina
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).
Time frame: Surgery to 4-weeks post-op
Quality of Life - mental function
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).
Time frame: Surgery to 4-weeks post-op
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.