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

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ClinicalTrials.gov Identifier: NCT03447938
Recruitment Status : Recruiting
First Posted : February 27, 2018
Last Update Posted : June 4, 2020
Sponsor:
Collaborators:
London Health Sciences Centre
Heart Center Leipzig - University Hospital
Fortis Escorts Heart Institute
The Methodist Hospital System
Carolinas Medical Center
Gundersen Lutheran Health System
Jilin Heart Hospital
Far Eastern Memorial Hospital
Medtronic
Apollo Hospitals
Ichinomiya-Nishi Hospital
Fresno Heart and Surgical Hospital
Information provided by (Responsible Party):
Ottawa Heart Institute Research Corporation

Tracking Information
First Submitted Date  ICMJE February 6, 2018
First Posted Date  ICMJE February 27, 2018
Last Update Posted Date June 4, 2020
Actual Study Start Date  ICMJE September 1, 2018
Estimated Primary Completion Date March 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 21, 2018)
Quality of life - physical function [ Time Frame: 4 weeks after surgery ]
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 generaly health perceptions.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 21, 2018)
  • Major Adverse Cardiac and Cerebrovascular Events (MACCE) and Target Vessel Revascularization (TVR) [ Time Frame: Through study completion, an average of 1 year after surgery. ]
    A composite endpoint of mortality, peri-operative myocardial infarction, non-peri-operative myocardial infarction, stroke, and new CABG or PCI associated with documented ischemia.
  • Number of bypass grafts [ Time Frame: During coronary artery bypass surgery ]
    A comparison of the mean number of bypass grafts performed between the two groups
  • Percentage of arterial grafts [ Time Frame: During coronary artery bypass surgery ]
    A comparison of the percentage of bypass grafts that are arterial between the groups
  • Intra-operative transfusion [ Time Frame: During coronary artery bypass surgery ]
    A comparison of the number of transfusions during surgery between the groups
  • Post-operative transfusion [ Time Frame: From the time of surgery until the patient is discharged from hospital, an average of 7 days ]
    A comparison of the number of transfusions after surgery between the groups
  • Re-exploration for bleeding [ Time Frame: From the time of surgery until the patient is discharged from hospital, an average of 7 days ]
    The incidence of re-exploration for bleeding after surgery
  • Post-operative pain [ Time Frame: From the time of surgery until the patient is discharged from hospital, an average of 7 days ]
    Measurement of patient's subjective assessment of their pain after surgery using a visual analog scale
  • Duration of intubation [ Time Frame: Measured from the time of arrival in the Intensive Care Unit until the time patients are extubated, an average of 12 hours. ]
    Comparison of the average duration of intubation between groups
  • Length of ICU stay [ Time Frame: From the time of surgery until the patient is discharged from hospital, an average of 7 days ]
    Comparison of the average number of days spent in Intensive Care Unit between groups
  • Length of hospital stay [ Time Frame: From the time of surgery until the patient is discharged from hospital, an average of 7 days ]
    Comparison of the average number of days spent in hospital between groups
  • Atrial fibrillation [ Time Frame: From the time of surgery until the patient is discharged from hospital, an average of 7 days ]
    Incidence of new-onset atrial fibrillation after cardiac surgery
  • Wound infection [ Time Frame: During the first 2 months after surgery ]
    Incidence of wound infections in each group
  • Angina [ Time Frame: 4 weeks after surgery ]
    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.
  • Quality of Life - mental function [ Time Frame: 4 weeks after surgery ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Minimally Invasive Coronary Surgery Compared to STernotomy Coronary Artery Bypass Grafting Trial
Official Title  ICMJE The Minimally Invasive Coronary Surgery Compared to STernotomy Coronary Artery Bypass Grafting Randomized Controlled Trial
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE
  • Procedure: MICS CABG
    Coronary artery bypass grafting performed through small incisions between the ribs.
    Other Name: Minimally invasive coronary artery bypass grafting
  • Procedure: Conventional CABG
    Coronary artery bypass grafting performed through an incision through the sternum or breastbone.
    Other Name: coronary artery bypass grafting via sternotomy
Study Arms  ICMJE
  • 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).
    Intervention: Procedure: 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.
    Intervention: Procedure: MICS CABG
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 21, 2018)
176
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 1, 2025
Estimated Primary Completion Date March 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Suzanne Crowe, CCRP 613-696-7000 ext 10656 scrowe@ottawaheart.ca
Listed Location Countries  ICMJE Canada,   China,   Germany,   India,   Japan,   Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03447938
Other Study ID Numbers  ICMJE 20180008
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Individual participant data will not be made available to other researchers.
Responsible Party Ottawa Heart Institute Research Corporation
Study Sponsor  ICMJE Ottawa Heart Institute Research Corporation
Collaborators  ICMJE
  • London Health Sciences Centre
  • Heart Center Leipzig - University Hospital
  • Fortis Escorts Heart Institute
  • The Methodist Hospital System
  • Carolinas Medical Center
  • Gundersen Lutheran Health System
  • Jilin Heart Hospital
  • Far Eastern Memorial Hospital
  • Medtronic
  • Apollo Hospitals
  • Ichinomiya-Nishi Hospital
  • Fresno Heart and Surgical Hospital
Investigators  ICMJE
Principal Investigator: Marc Ruel, MD Ottawa Heart Institute Research Corporation
PRS Account Ottawa Heart Institute Research Corporation
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP