The Minimally Invasive Coronary Surgery Compared to STernotomy Coronary Artery Bypass Grafting Trial
Running, not enrolling · Not applicable
Conditions studied: Coronary Artery Disease
In brief
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.
Key facts
- Study ID
- NCT03447938
- Run by
- Ottawa Heart Institute Research Corporation
- People needed
- 176
- Starts
- 2018-09-01
- Expected to finish
- 2028-03-01
- Last updated by the study team
- 2026-05-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- <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.
Where it is running
- 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
- Tokyo Bay Urayasu Ichikawa Medical Center — Urayasu, Chiba, Japan
- National University Hospital (NUH) - Singapore — Singapore, Singapore
- Far-Eastern Memorial Hospital — Taipei, Taipei, Taiwan
Full record on ClinicalTrials.gov
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