The Minimally Invasive Coronary Surgery Compared to STernotomy Coronary Artery Bypass Grafting Trial (MIST)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Procedure: Conventional CABG; Procedure: MICS CABG

• Study Type: Interventional
• Enrollment (Estimated): 176
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium
    • Universitaire Ziekenhuizen Leuven
• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1Y 4W7
      • Division of Cardiac Surgery, University of Ottawa Heart Institute
    • Toronto, Ontario, Canada
      • University Health Network
• China
  • Jilin
    • Jilin, Jilin, China, 130117
      • Jilin Heart Hospital
• Germany
  • Stuttgart, Germany
    • Robert-Bosch-Hospital
  • Saxony
    • Leipzig, Saxony, Germany
      • Leipzig Heart Institute GmbH
• India
  • Karnataka
    • Bangalore, Karnataka, India, 560041
      • Apollo Hospital, Bangalore
  • National Capital Territory of Delhi
    • New Delhi, National Capital Territory of Delhi, India
      • Manipal Hospitals
• Japan
  • Chiba
    • Urayasu, Chiba, Japan
      • Tokyo Bay Urayasu Ichikawa Medical Center
• Singapore
  • Singapore, Singapore
    • National University Hospital (NUH) - Singapore
• Taiwan
  • Taipei
    • Taipei, Taipei, Taiwan, 220
      • Far-Eastern Memorial Hospital
• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University Of Pittsburgh Medical Center
  • Wisconsin
    • La Crosse, Wisconsin, United States, 54601
      • Gundersen Lutheran Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).	Procedure: Conventional CABG; Coronary artery bypass grafting performed through an incision through the sternum or breastbone.; Other Names: coronary artery bypass grafting via sternotomy
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.	Procedure: MICS CABG; Coronary artery bypass grafting performed through small incisions between the ribs.; Other Names: Minimally invasive coronary artery bypass grafting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life - physical function	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).	Surgery to 4 weeks post-op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Adverse Cardiac and Cerebrovascular Events (MACCE) and Target Vessel Revascularization (TVR)	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).	Surgery to study completion (average of 1 year after surgery.)
Number of bypass grafts	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).	During coronary artery bypass surgery
Percentage of arterial grafts	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).	During coronary artery bypass surgery
Intra-operative transfusion	A comparison of the number of transfusions during surgery between the groups Analysis restricted to high-volume recruiting centers (>10 patients through study).	During coronary artery bypass surgery
Post-operative transfusion	A comparison of the number of transfusions after surgery between the groups Analysis restricted to high-volume recruiting centers (>10 patients through study).	Surgery to hospital discharge (average of 7 days)
Re-exploration for bleeding	The incidence of re-exploration for bleeding after surgery Analysis restricted to high-volume recruiting centers (>10 patients through study).	Surgery to hospital discharge (average of 7 days)
Post-operative pain	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).	Surgery to hospital discharge (average of 7 days)
Duration of intubation	Comparison of the average duration of intubation between groups Analysis restricted to high-volume recruiting centers (>10 patients through study).	Time of arrival in the Intensive Care Unit until extubation. (average of 12 hours.)
Length of ICU stay	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).	Surgery to hospital discharge (average of 7 days)
Length of hospital stay	Comparison of the average number of days spent in hospital between groups Analysis restricted to high-volume recruiting centers (>10 patients through study).	Surgery to hospital discharge (average of 7 days)
Atrial fibrillation	Incidence of new-onset atrial fibrillation after cardiac surgery Analysis restricted to high-volume recruiting centers (>10 patients through study).	Surgery to hospital discharge (average of 7 days)
Wound infection	Incidence of wound infections in each group Analysis restricted to high-volume recruiting centers (>10 patients through study).	Surgery to 2-months post-op
Angina	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).	Surgery to 4-weeks post-op
Quality of Life - mental function	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).	Surgery to 4-weeks post-op

Collaborators and Investigators

• Sponsor: Ottawa Heart Institute Research Corporation
• Collaborators: Far Eastern Memorial Hospital; London Health Sciences Centre; Medtronic; The Methodist Hospital Research Institute; Carolinas Medical Center; Heart Center Leipzig - University Hospital; Fortis Escorts Heart Institute; Gundersen Lutheran Health System; Jilin Heart Hospital; Apollo Hospitals Enterprise Limited; Fresno Heart and Surgical Hospital; Ichinomiya-Nishi Hospital
• Investigators: Principal Investigator: Marc Ruel, MD, Ottawa Heart Institute Research Corporation

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): January 31, 2025
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: February 6, 2018
• First Submitted That Met QC Criteria: February 21, 2018
• First Posted (Actual): February 27, 2018

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: 20180008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be made available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No