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
NOT_YET_RECRUITINGGundersen Lutheran Medical Center
La Crosse, Wisconsin, United States
RECRUITINGUniversitaire Ziekenhuizen Leuven
Leuven, Belgium
NOT_YET_RECRUITINGDivision of Cardiac Surgery, University of Ottawa Heart Institute
Ottawa, Ontario, Canada
RECRUITINGUniversity Health Network
Toronto, Ontario, Canada
NOT_YET_RECRUITINGJilin Heart Hospital
Jilin, Jilin, China
RECRUITINGLeipzig Heart Institute GmbH
Leipzig, Saxony, Germany
RECRUITINGRobert-Bosch-Hospital
Stuttgart, Germany
NOT_YET_RECRUITINGApollo Hospital, Bangalore
Bangalore, Karnataka, India
RECRUITINGManipal Hospitals
New Delhi, National Capital Territory of Delhi, India
NOT_YET_RECRUITING...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 generaly health perceptions.
Time frame: 4 weeks after surgery
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.
Time frame: Through study completion, an average of 1 year after surgery.
Number of bypass grafts
A comparison of the mean number of bypass grafts performed between the two groups
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
Time frame: During coronary artery bypass surgery
Intra-operative transfusion
A comparison of the number of transfusions during surgery between the groups
Time frame: During coronary artery bypass surgery
Post-operative transfusion
A comparison of the number of transfusions after surgery between the groups
Time frame: From the time of surgery until the patient is discharged from hospital, an average of 7 days
Re-exploration for bleeding
The incidence of re-exploration for bleeding after surgery
Time frame: From the time of surgery until the patient is discharged from hospital, an average of 7 days
Post-operative pain
Measurement of patient's subjective assessment of their pain after surgery using a visual analog scale
Time frame: From the time of surgery until the patient is discharged from hospital, an average of 7 days
Duration of intubation
Comparison of the average duration of intubation between groups
Time frame: Measured from the time of arrival in the Intensive Care Unit until the time patients are extubated, an average of 12 hours.
Length of ICU stay
Comparison of the average number of days spent in Intensive Care Unit between groups
Time frame: From the time of surgery until the patient is discharged from hospital, an average of 7 days
Length of hospital stay
Comparison of the average number of days spent in hospital between groups
Time frame: From the time of surgery until the patient is discharged from hospital, an average of 7 days
Atrial fibrillation
Incidence of new-onset atrial fibrillation after cardiac surgery
Time frame: From the time of surgery until the patient is discharged from hospital, an average of 7 days
Wound infection
Incidence of wound infections in each group
Time frame: During the first 2 months after surgery
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.
Time frame: 4 weeks after surgery
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.
Time frame: 4 weeks after surgery
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