Coronary Artery DiseaseMISTNCT03447938
The Minimally Invasive Coronary Surgery Compared to STernotomy Coronary Artery Bypass Grafting Trial
A study testing MICS CABG and Conventional CABG in people with Coronary Artery Disease, run by Ottawa Heart Institute Research Corporation at 13 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- MICS CABG and Conventional CABG
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 13 sitesin 9 countries
- Study dates
- 1 Sep 2018to 1 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- <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.
Trial locations and contacts
13 sites in 9 countries.
13 sites in 9 countries
United States2 sites
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Canada2 sites
Division of Cardiac Surgery, University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
University Health Network
Toronto, Ontario
Germany2 sites
Leipzig Heart Institute GmbH
Leipzig, Saxony
Robert-Bosch-Hospital
Stuttgart
India2 sites
Apollo Hospital, Bangalore
Bangalore, Karnataka, 560041
Manipal Hospitals
New Delhi, National Capital Territory of Delhi
About this study
Official title: 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.
- Conditions
- Coronary Artery Disease
- Being tested
- MICS CABG, Conventional CABG
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MICS CABGProcedure or surgery
Also called Minimally invasive coronary artery bypass grafting
Coronary artery bypass grafting performed through small incisions between the ribs.
Conventional CABGProcedure or surgery
Also called coronary artery bypass grafting via sternotomy
Coronary artery bypass grafting performed through an incision through the sternum or breastbone.
| Study group | Role | What they receive |
|---|---|---|
| CABG with sternotomy | Active comparator | 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). Receives: Procedure: Conventional CABG |
| Minimally-invasive CABG | Experimental | Patients in this group will undergo coronary artery bypass grafting (CABG) using a minimally-invasive approach (MICS CABG), through smaller incisions between the ribs. Receives: Procedure: MICS CABG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Surgery to 4 weeks post-op
Secondary outcomes (14)
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Surgery to 4-weeks post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start1 Sep 2018
- Primary completion31 Jan 2025
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Ottawa Heart Institute Research CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Marc Ruel, MD, Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03447938
- Sponsor's protocol ID
- 20180008
- Acronym
- MIST
- Status last verified
- Apr 2026
- First submitted
- 6 Feb 2018
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made available to other researchers.
Publications
Ruel M, Nambala S, Guo MH, Verevkin A, Rabindranauth P, Kikuchi K, Davierwala PM, Lemma M, Ponnambalam M, Sheikh A, Black A, Borger MA, Whitlock RP, Zhang Y, Wells GA. Multivessel coronary artery bypass grafting via small thoracotomy versus sternotomy (MIST): an investigator-initiated, international, open-label, randomised controlled trial. Lancet. 2026 Jul 31:S0140-6736(26)01288-2. doi: 10.1016/S0140-6736(26)01288-2. Online ahead of print.
PubMed 42537680
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Minimally Invasive Coronary Surgery Compared to STernotomy Coronary Artery Bypass Grafting Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03447938
- Acronym / sponsor ID
- MIST / 20180008
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- 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
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 27 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CABG with sternotomy | Active comparator | Procedure: Conventional CABGPatients 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). |
| Minimally-invasive CABG | Experimental | Procedure: MICS CABGPatients in this group will undergo coronary artery bypass grafting (CABG) using a minimally-invasive approach (MICS CABG), through smaller incisions between the ribs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- <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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MICS CABGAlso: Minimally invasive coronary artery bypass graftingCoronary artery bypass grafting performed through small incisions between the ribs. | Procedure or surgery | Minimally-invasive CABG |
| Conventional CABGAlso: coronary artery bypass grafting via sternotomyCoronary artery bypass grafting performed through an incision through the sternum or breastbone. | Procedure or surgery | CABG with sternotomy |
Primary outcome
Quality of life - physical function
Time frame: Surgery to 4 weeks post-op
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).
14 secondary outcomes
Major Adverse Cardiac and Cerebrovascular Events (MACCE) and Target Vessel Revascularization (TVR)
Time frame: Surgery to study completion (average of 1 year after surgery.)
Number of bypass grafts
Time frame: During coronary artery bypass surgery
Percentage of arterial grafts
Time frame: During coronary artery bypass surgery
Intra-operative transfusion
Time frame: During coronary artery bypass surgery
Post-operative transfusion
Time frame: Surgery to hospital discharge (average of 7 days)
Re-exploration for bleeding
Time frame: Surgery to hospital discharge (average of 7 days)
Post-operative pain
Time frame: Surgery to hospital discharge (average of 7 days)
Duration of intubation
Time frame: Time of arrival in the Intensive Care Unit until extubation. (average of 12 hours.)
Length of ICU stay
Time frame: Surgery to hospital discharge (average of 7 days)
Length of hospital stay
Time frame: Surgery to hospital discharge (average of 7 days)
Atrial fibrillation
Time frame: Surgery to hospital discharge (average of 7 days)
Wound infection
Time frame: Surgery to 2-months post-op
Angina
Time frame: Surgery to 4-weeks post-op
Quality of Life - mental function
Time frame: Surgery to 4-weeks post-op
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Derived from this study: PubMed 42537680Ruel M, Nambala S, Guo MH, Verevkin A, Rabindranauth P, Kikuchi K, Davierwala PM, Lemma M, Ponnambalam M, Sheikh A, Black A, Borger MA, Whitlock RP, Zhang Y, Wells GA. Multivessel coronary artery bypass grafting via small thoracotomy versus sternotomy (MIST): an investigator-initiated, international, open-label, randomised controlled trial. Lancet. 2026 Jul 31:S0140-6736(26)01288-2. doi: 10.1016/S0140-6736(26)01288-2. Online ahead of print.
- Individual participant dataSharing planned: No. Individual participant data will not be made available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Ruel, MD principal investigator
Ottawa Heart Institute Research Corporation
13 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MICS CABG and Conventional CABG in people with Coronary Artery Disease, run by Ottawa Heart Institute Research Corporation at 13 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Canada, Germany, India, Belgium and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life - physical function (time frame: Surgery to 4 weeks post-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03447938, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.