Minimally invasive coronary surgery versus traditional surgery for heart bypass
The Minimally Invasive Coronary Surgery Compared to STernotomy Coronary Artery Bypass Grafting Randomized Controlled Trial
This study is testing if a less invasive heart bypass surgery can help people with multiple blocked arteries recover faster and feel better compared to traditional surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 176 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ottawa Heart Institute Research Corporation Academic / other |
| Locations | 13 sites (Pittsburgh, Pennsylvania and 12 other locations) |
| Trial ID | NCT03447938 on ClinicalTrials.gov |
What this trial studies
This trial compares minimally invasive coronary artery bypass grafting (MICS CABG) to conventional sternotomy CABG in patients with multi-vessel coronary artery disease. It aims to assess the quality of life and recovery times in the early post-operative period through a randomized control design. Patients eligible for both surgical approaches will be enrolled to provide a robust comparison of outcomes. The study is multi-centre and prospective, ensuring a diverse patient population and comprehensive data collection.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with multi-vessel coronary artery disease suitable for either minimally invasive or conventional surgery.
Not a fit: Patients with concomitant cardiac procedures, previous cardiac surgeries, or significant contraindications for minimally invasive surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery times and quality of life for patients undergoing coronary artery bypass surgery.
How similar studies have performed: Previous observational studies have suggested benefits of minimally invasive approaches, but this trial aims to provide higher-level evidence through a randomized design.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Pittsburgh, Pennsylvania and 12 other locations
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (Not_yet_recruiting)
- Gundersen Lutheran Medical Center — La Crosse, Wisconsin, United States (Recruiting)
- Universitaire Ziekenhuizen Leuven — Leuven, Belgium (Not_yet_recruiting)
- Division of Cardiac Surgery, University of Ottawa Heart Institute — Ottawa, Ontario, Canada (Recruiting)
- University Health Network — Toronto, Ontario, Canada (Not_yet_recruiting)
- Jilin Heart Hospital — Jilin, Jilin, China (Recruiting)
- Leipzig Heart Institute GmbH — Leipzig, Saxony, Germany (Recruiting)
- Robert-Bosch-Hospital — Stuttgart, Germany (Not_yet_recruiting)
- Manipal Hospitals — New Delhi, Delhi, India (Not_yet_recruiting)
- Apollo Hospital, Bangalore — Bangalore, Karnataka, India (Recruiting)
- Tokyo Bay Urayasu Ichikawa Medical Center — Urayasu, Chiba, Japan (Not_yet_recruiting)
- National University Hospital (NUH) - Singapore — Singapore, Singapore (Recruiting)
- Far-Eastern Memorial Hospital — Taipei, Taiwan (Not_yet_recruiting)
Study contacts
- Principal investigator: Marc Ruel, MD — Ottawa Heart Institute Research Corporation
- Study coordinator: Mary Zhang, MD, PhD
- Email: mzhang@ottawaheart.ca
- Phone: 613-696-7230
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.