The Minimally Invasive Coronary Surgery Compared to STernotomy Coronary Artery Bypass Grafting Trial
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/26/2018 |
| Start Date: | May 18, 2018 |
| End Date: | April 1, 2021 |
The Minimally Invasive Coronary Surgery Compared to STernotomy Coronary Artery Bypass Grafting Randomized Controlled Trial
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.
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.
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.
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