- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03447938
The Minimally Invasive Coronary Surgery Compared to STernotomy Coronary Artery Bypass Grafting Trial (MIST)
January 8, 2024 updated by: Ottawa Heart Institute Research Corporation
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
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
176
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mary Zhang, MD, PhD
- Phone Number: 613-696-7230
- Email: mzhang@ottawaheart.ca
Study Locations
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Leuven, Belgium
- Not yet recruiting
- Universitaire Ziekenhuizen Leuven
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Contact:
- Wouter Oosterlinck
- Email: wouter.oosterlinck@uzleuven.be
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Ontario
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Ottawa, Ontario, Canada, K1Y 4W7
- Recruiting
- Division of Cardiac Surgery, University of Ottawa Heart Institute
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Contact:
- Marc Ruel, MD MPH FRCSC
- Phone Number: 613-761-4893
- Email: mruel@ottawaheart.ca
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Contact:
- Mary Zhang, MD, PhD
- Phone Number: 613-696-7230
- Email: mzhang@ottawaheart.ca
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Toronto, Ontario, Canada
- Not yet recruiting
- University Health Network
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Contact:
- Piroze Davierwala, MD
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Contact:
- Email: Piroze.Davierwala@uhn.ca
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Jilin
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Jilin, Jilin, China, 130117
- Recruiting
- Jilin Heart Hospital
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Contact:
- Massimo Lemma, MD
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Stuttgart, Germany
- Not yet recruiting
- Robert-Bosch-Hospital
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Contact:
- Marc Albert, MD
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Contact:
- Email: Marc.albert@rbk.de
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Saxony
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Leipzig, Saxony, Germany
- Recruiting
- Leipzig Heart Institute GmbH
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Contact:
- Julia Krebs
- Email: Julia.Krebs@leipzig-heart.de
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Principal Investigator:
- Michael Borger, MD
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Delhi
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New Delhi, Delhi, India
- Not yet recruiting
- Manipal Hospitals
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Contact:
- Yugal Mishra, MD
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Karnataka
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Bangalore, Karnataka, India, 560041
- Recruiting
- Apollo Hospital, Bangalore
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Contact:
- Sathyaki Nambala
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Chiba
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Urayasu, Chiba, Japan
- Not yet recruiting
- Tokyo Bay Urayasu Ichikawa Medical Center
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Contact:
- Keita Kikuchi, MD
- Email: kikuchi-cvs@outlook.com
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Singapore, Singapore
- Recruiting
- National University Hospital (NUH) - Singapore
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Contact:
- Theodoros Kofidis, MD
- Email: surtk@nus.edu.sg
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Taipei, Taiwan, 220
- Not yet recruiting
- Far-Eastern Memorial Hospital
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Contact:
- Kuan-Ming Chiu, MD
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- Not yet recruiting
- University of Pittsburgh Medical Center
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Contact:
- Johannes Bonatti, MD
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Contact:
- Phone Number: (412) 648-6200
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Wisconsin
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La Crosse, Wisconsin, United States, 54601
- Recruiting
- Gundersen Lutheran Medical Center
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Contact:
- Prem Rabindra, MD
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
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).
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Coronary artery bypass grafting performed through an incision through the sternum or breastbone.
Other Names:
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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.
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Coronary artery bypass grafting performed through small incisions between the ribs.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of life - physical function
Time Frame: 4 weeks after surgery
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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.
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4 weeks after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Major Adverse Cardiac and Cerebrovascular Events (MACCE) and Target Vessel Revascularization (TVR)
Time Frame: Through study completion, an average of 1 year after surgery.
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A composite endpoint of mortality, peri-operative myocardial infarction, non-peri-operative myocardial infarction, stroke, and new CABG or PCI associated with documented ischemia.
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Through study completion, an average of 1 year after surgery.
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Number of bypass grafts
Time Frame: During coronary artery bypass surgery
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A comparison of the mean number of bypass grafts performed between the two groups
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During coronary artery bypass surgery
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Percentage of arterial grafts
Time Frame: During coronary artery bypass surgery
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A comparison of the percentage of bypass grafts that are arterial between the groups
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During coronary artery bypass surgery
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Intra-operative transfusion
Time Frame: During coronary artery bypass surgery
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A comparison of the number of transfusions during surgery between the groups
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During coronary artery bypass surgery
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Post-operative transfusion
Time Frame: From the time of surgery until the patient is discharged from hospital, an average of 7 days
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A comparison of the number of transfusions after surgery between the groups
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From the time of surgery until the patient is discharged from hospital, an average of 7 days
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Re-exploration for bleeding
Time Frame: From the time of surgery until the patient is discharged from hospital, an average of 7 days
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The incidence of re-exploration for bleeding after surgery
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From the time of surgery until the patient is discharged from hospital, an average of 7 days
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Post-operative pain
Time Frame: From the time of surgery until the patient is discharged from hospital, an average of 7 days
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Measurement of patient's subjective assessment of their pain after surgery using a visual analog scale
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From the time of surgery until the patient is discharged from hospital, an average of 7 days
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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.
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Comparison of the average duration of intubation between groups
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Measured from the time of arrival in the Intensive Care Unit until the time patients are extubated, an average of 12 hours.
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Length of ICU stay
Time Frame: From the time of surgery until the patient is discharged from hospital, an average of 7 days
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Comparison of the average number of days spent in Intensive Care Unit between groups
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From the time of surgery until the patient is discharged from hospital, an average of 7 days
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Length of hospital stay
Time Frame: From the time of surgery until the patient is discharged from hospital, an average of 7 days
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Comparison of the average number of days spent in hospital between groups
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From the time of surgery until the patient is discharged from hospital, an average of 7 days
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Atrial fibrillation
Time Frame: From the time of surgery until the patient is discharged from hospital, an average of 7 days
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Incidence of new-onset atrial fibrillation after cardiac surgery
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From the time of surgery until the patient is discharged from hospital, an average of 7 days
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Wound infection
Time Frame: During the first 2 months after surgery
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Incidence of wound infections in each group
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During the first 2 months after surgery
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Angina
Time Frame: 4 weeks after surgery
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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.
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4 weeks after surgery
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Quality of Life - mental function
Time Frame: 4 weeks after surgery
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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.
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4 weeks after surgery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Marc Ruel, MD, Ottawa Heart Institute Research Corporation
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2018
Primary Completion (Estimated)
March 1, 2026
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)
January 10, 2024
Last Update Submitted That Met QC Criteria
January 8, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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