Coronary Artery Disease
Conditions
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.
Interventions
PROCEDUREMICS CABG
Coronary artery bypass grafting performed through small incisions between the ribs.
PROCEDUREConventional CABG
Coronary artery bypass grafting performed through an incision through the sternum or breastbone.
Sponsors
Ottawa Heart Institute Research Corporation
London Health Sciences Centre
Heart Center Leipzig - University Hospital
Fortis Escorts Heart Institute
The Methodist Hospital Research Institute
Carolinas Medical Center
Gundersen Lutheran Health System
Jilin Heart Hospital
Far Eastern Memorial Hospital
Medtronic
Apollo Hospitals Enterprise Limited
Fresno Heart and Surgical Hospital
Ichinomiya-Nishi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* \<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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life - physical function | Surgery to 4 weeks post-op | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Cardiac and Cerebrovascular Events (MACCE) and Target Vessel Revascularization (TVR) | Surgery to study completion (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. Analysis restricted to high-volume recruiting centers (\>10 patients through study). |
| Number of bypass grafts | During coronary artery bypass surgery | 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). |
| Percentage of arterial grafts | During coronary artery bypass surgery | 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). |
| Intra-operative transfusion | During coronary artery bypass surgery | A comparison of the number of transfusions during surgery between the groups Analysis restricted to high-volume recruiting centers (\>10 patients through study). |
| Post-operative transfusion | Surgery to hospital discharge (average of 7 days) | A comparison of the number of transfusions after surgery between the groups Analysis restricted to high-volume recruiting centers (\>10 patients through study). |
| Re-exploration for bleeding | Surgery to hospital discharge (average of 7 days) | The incidence of re-exploration for bleeding after surgery Analysis restricted to high-volume recruiting centers (\>10 patients through study). |
| Post-operative pain | Surgery to hospital discharge (average of 7 days) | 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). |
| Duration of intubation | Time of arrival in the Intensive Care Unit until extubation. (average of 12 hours.) | Comparison of the average duration of intubation between groups Analysis restricted to high-volume recruiting centers (\>10 patients through study). |
| Length of ICU stay | Surgery to hospital discharge (average of 7 days) | 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). |
| Length of hospital stay | Surgery to hospital discharge (average of 7 days) | Comparison of the average number of days spent in hospital between groups Analysis restricted to high-volume recruiting centers (\>10 patients through study). |
| Atrial fibrillation | Surgery to hospital discharge (average of 7 days) | Incidence of new-onset atrial fibrillation after cardiac surgery Analysis restricted to high-volume recruiting centers (\>10 patients through study). |
| Wound infection | Surgery to 2-months post-op | Incidence of wound infections in each group Analysis restricted to high-volume recruiting centers (\>10 patients through study). |
| Angina | Surgery to 4-weeks post-op | 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). |
| Quality of Life - mental function | Surgery to 4-weeks post-op | 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). |
Countries
Belgium, Canada, China, Germany, India, Japan, Singapore, Taiwan, United States
Contacts
PRINCIPAL_INVESTIGATORMarc Ruel, MD
Ottawa Heart Institute Research Corporation
Outcome results
None listed