search
Back to results

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

Primary Purpose

Coronary Artery Disease

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
MICS CABG
Conventional CABG
Sponsored by
Ottawa Heart Institute Research Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Pittsburgh Medical Center
  • Gundersen Lutheran Medical CenterRecruiting
  • Universitaire Ziekenhuizen Leuven
  • Division of Cardiac Surgery, University of Ottawa Heart InstituteRecruiting
  • University Health Network
  • Jilin Heart HospitalRecruiting
  • Leipzig Heart Institute GmbHRecruiting
  • Robert-Bosch-Hospital
  • Manipal Hospitals
  • Apollo Hospital, BangaloreRecruiting
  • Tokyo Bay Urayasu Ichikawa Medical Center
  • National University Hospital (NUH) - SingaporeRecruiting
  • Far-Eastern Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

CABG with sternotomy

Minimally-invasive CABG

Arm Description

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).

Patients in this group will undergo coronary artery bypass grafting (CABG) using a minimally-invasive approach (MICS CABG), through smaller incisions between the ribs.

Outcomes

Primary Outcome Measures

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 generaly health perceptions.

Secondary Outcome Measures

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.
Number of bypass grafts
A comparison of the mean number of bypass grafts performed between the two groups
Percentage of arterial grafts
A comparison of the percentage of bypass grafts that are arterial between the groups
Intra-operative transfusion
A comparison of the number of transfusions during surgery between the groups
Post-operative transfusion
A comparison of the number of transfusions after surgery between the groups
Re-exploration for bleeding
The incidence of re-exploration for bleeding after surgery
Post-operative pain
Measurement of patient's subjective assessment of their pain after surgery using a visual analog scale
Duration of intubation
Comparison of the average duration of intubation between groups
Length of ICU stay
Comparison of the average number of days spent in Intensive Care Unit between groups
Length of hospital stay
Comparison of the average number of days spent in hospital between groups
Atrial fibrillation
Incidence of new-onset atrial fibrillation after cardiac surgery
Wound infection
Incidence of wound infections in each group
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.
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.

Full Information

First Posted
February 6, 2018
Last Updated
November 8, 2022
Sponsor
Ottawa Heart Institute Research Corporation
Collaborators
London Health Sciences Centre, Heart Center Leipzig - University Hospital, Fortis Escorts Heart Institute, The Methodist Hospital Research Institute, Carolinas Medical Center, Gundersen Lutheran Health System, Jilin Heart Hospital, Far Eastern Memorial Hospital, Medtronic, Apollo Hospitals Enterprise Limited, Fresno Heart and Surgical Hospital, Ichinomiya-Nishi Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03447938
Brief Title
The Minimally Invasive Coronary Surgery Compared to STernotomy Coronary Artery Bypass Grafting Trial
Acronym
MIST
Official Title
The Minimally Invasive Coronary Surgery Compared to STernotomy Coronary Artery Bypass Grafting Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
March 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Heart Institute Research Corporation
Collaborators
London Health Sciences Centre, Heart Center Leipzig - University Hospital, Fortis Escorts Heart Institute, The Methodist Hospital Research Institute, Carolinas Medical Center, Gundersen Lutheran Health System, Jilin Heart Hospital, Far Eastern Memorial Hospital, Medtronic, Apollo Hospitals Enterprise Limited, Fresno Heart and Surgical Hospital, Ichinomiya-Nishi Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
176 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CABG with sternotomy
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Minimally-invasive CABG
Arm Type
Experimental
Arm Description
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 Type
Procedure
Intervention Name(s)
MICS CABG
Other Intervention Name(s)
Minimally invasive coronary artery bypass grafting
Intervention Description
Coronary artery bypass grafting performed through small incisions between the ribs.
Intervention Type
Procedure
Intervention Name(s)
Conventional CABG
Other Intervention Name(s)
coronary artery bypass grafting via sternotomy
Intervention Description
Coronary artery bypass grafting performed through an incision through the sternum or breastbone.
Primary Outcome Measure Information:
Title
Quality of life - physical function
Description
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.
Time Frame
4 weeks after surgery
Secondary Outcome Measure Information:
Title
Major Adverse Cardiac and Cerebrovascular Events (MACCE) and Target Vessel Revascularization (TVR)
Description
A composite endpoint of mortality, peri-operative myocardial infarction, non-peri-operative myocardial infarction, stroke, and new CABG or PCI associated with documented ischemia.
Time Frame
Through study completion, an average of 1 year after surgery.
Title
Number of bypass grafts
Description
A comparison of the mean number of bypass grafts performed between the two groups
Time Frame
During coronary artery bypass surgery
Title
Percentage of arterial grafts
Description
A comparison of the percentage of bypass grafts that are arterial between the groups
Time Frame
During coronary artery bypass surgery
Title
Intra-operative transfusion
Description
A comparison of the number of transfusions during surgery between the groups
Time Frame
During coronary artery bypass surgery
Title
Post-operative transfusion
Description
A comparison of the number of transfusions after surgery between the groups
Time Frame
From the time of surgery until the patient is discharged from hospital, an average of 7 days
Title
Re-exploration for bleeding
Description
The incidence of re-exploration for bleeding after surgery
Time Frame
From the time of surgery until the patient is discharged from hospital, an average of 7 days
Title
Post-operative pain
Description
Measurement of patient's subjective assessment of their pain after surgery using a visual analog scale
Time Frame
From the time of surgery until the patient is discharged from hospital, an average of 7 days
Title
Duration of intubation
Description
Comparison of the average duration of intubation between groups
Time Frame
Measured from the time of arrival in the Intensive Care Unit until the time patients are extubated, an average of 12 hours.
Title
Length of ICU stay
Description
Comparison of the average number of days spent in Intensive Care Unit between groups
Time Frame
From the time of surgery until the patient is discharged from hospital, an average of 7 days
Title
Length of hospital stay
Description
Comparison of the average number of days spent in hospital between groups
Time Frame
From the time of surgery until the patient is discharged from hospital, an average of 7 days
Title
Atrial fibrillation
Description
Incidence of new-onset atrial fibrillation after cardiac surgery
Time Frame
From the time of surgery until the patient is discharged from hospital, an average of 7 days
Title
Wound infection
Description
Incidence of wound infections in each group
Time Frame
During the first 2 months after surgery
Title
Angina
Description
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.
Time Frame
4 weeks after surgery
Title
Quality of Life - mental function
Description
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.
Time Frame
4 weeks after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mary Zhang, MD, PhD
Phone
613-696-7230
Email
mzhang@ottawaheart.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Ruel, MD
Organizational Affiliation
Ottawa Heart Institute Research Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johannes Bonatti, MD
Phone
(412) 648-6200
Facility Name
Gundersen Lutheran Medical Center
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prem Rabindra, MD
Facility Name
Universitaire Ziekenhuizen Leuven
City
Leuven
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wouter Oosterlinck
Email
wouter.oosterlinck@uzleuven.be
Facility Name
Division of Cardiac Surgery, University of Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc Ruel, MD MPH FRCSC
Phone
613-761-4893
Email
mruel@ottawaheart.ca
First Name & Middle Initial & Last Name & Degree
Mary Zhang, MD, PhD
Phone
613-696-7230
Email
mzhang@ottawaheart.ca
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Piroze Davierwala, MD
Email
Piroze.Davierwala@uhn.ca
Facility Name
Jilin Heart Hospital
City
Jilin
State/Province
Jilin
ZIP/Postal Code
130117
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Massimo Lemma, MD
Facility Name
Leipzig Heart Institute GmbH
City
Leipzig
State/Province
Saxony
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julia Krebs
Email
Julia.Krebs@leipzig-heart.de
First Name & Middle Initial & Last Name & Degree
Michael Borger, MD
Facility Name
Robert-Bosch-Hospital
City
Stuttgart
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc Albert, MD
Email
Marc.albert@rbk.de
Facility Name
Manipal Hospitals
City
New Delhi
State/Province
Delhi
Country
India
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yugal Mishra, MD
Facility Name
Apollo Hospital, Bangalore
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560041
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sathyaki Nambala
Facility Name
Tokyo Bay Urayasu Ichikawa Medical Center
City
Urayasu
State/Province
Chiba
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keita Kikuchi, MD
Email
kikuchi-cvs@outlook.com
Facility Name
National University Hospital (NUH) - Singapore
City
Singapore
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Theodoros Kofidis, MD
Email
surtk@nus.edu.sg
Facility Name
Far-Eastern Memorial Hospital
City
Taipei
ZIP/Postal Code
220
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kuan-Ming Chiu, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be made available to other researchers.

Learn more about this trial

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

We'll reach out to this number within 24 hrs