The Minimally Invasive Coronary Surgery Compared to STernotomy Coronary Artery Bypass Grafting Randomized Controlled Trial

Status: Recruiting
Location: See all (13) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Pennsylvania
University of Pittsburgh Medical Center
NOT_YET_RECRUITING
Pittsburgh
Wisconsin
Gundersen Lutheran Medical Center
RECRUITING
La Crosse
Other Locations
Belgium
Universitaire Ziekenhuizen Leuven
NOT_YET_RECRUITING
Leuven
Canada
Division of Cardiac Surgery, University of Ottawa Heart Institute
RECRUITING
Ottawa
University Health Network
NOT_YET_RECRUITING
Toronto
China
Jilin Heart Hospital
RECRUITING
Jilin
Germany
Leipzig Heart Institute GmbH
RECRUITING
Leipzig
Robert-Bosch-Hospital
NOT_YET_RECRUITING
Stuttgart
India
Apollo Hospital, Bangalore
RECRUITING
Bangalore
Manipal Hospitals
NOT_YET_RECRUITING
New Delhi
Japan
Tokyo Bay Urayasu Ichikawa Medical Center
NOT_YET_RECRUITING
Urayasu
Singapore
National University Hospital (NUH) - Singapore
RECRUITING
Singapore
Taiwan
Far-Eastern Memorial Hospital
NOT_YET_RECRUITING
Taipei
Contact Information
Primary
Mary Zhang, MD, PhD
mzhang@ottawaheart.ca
613-696-7230
Time Frame
Start Date: 2018-09-01
Estimated Completion Date: 2028-03-01
Participants
Target number of participants: 176
Treatments
Active_comparator: CABG with sternotomy
Patients in this group will undergo coronary artery bypass grafting (CABG) in the usual way, through an incision in the middle of the chest, through the breastbone or sternum (conventional CABG).
Experimental: Minimally-invasive CABG
Patients in this group will undergo coronary artery bypass grafting (CABG) using a minimally-invasive approach (MICS CABG), through smaller incisions between the ribs.
Sponsors
Collaborators: Jilin Heart Hospital, Carolinas Medical Center, Heart Center Leipzig - University Hospital, Medtronic, Ichinomiya-Nishi Hospital, Apollo Hospitals Enterprise Limited, London Health Sciences Centre, The Methodist Hospital Research Institute, Gundersen Lutheran Health System, Fresno Heart and Surgical Hospital, Far Eastern Memorial Hospital, Fortis Escorts Heart Institute
Leads: Ottawa Heart Institute Research Corporation

This content was sourced from clinicaltrials.gov