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NCT Number: NCT03447938

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

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitaire Ziekenhuizen Leuven, Leuven, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MICS CABG

Procedure

Coronary artery bypass grafting performed through small incisions between the ribs.

Other names: Minimally invasive coronary artery bypass grafting

Conventional CABG

Procedure

Coronary artery bypass grafting performed through an incision through the sternum or breastbone.

Other names: coronary artery bypass grafting via sternotomy

Primary outcomes

  1. 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).

Secondary outcomes

  1. Major Adverse Cardiac and Cerebrovascular Events (MACCE) and Target Vessel Revascularization (TVR)

    Time frame: Surgery to study completion (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.

    Analysis restricted to high-volume recruiting centers (>10 patients through study).

  2. 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 Analysis restricted to high-volume recruiting centers (>10 patients through study).

  3. 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.

    Analysis restricted to high-volume recruiting centers (>10 patients through study).

  4. Intra-operative transfusion

    Time frame: During coronary artery bypass surgery

    A comparison of the number of transfusions during surgery between the groups Analysis restricted to high-volume recruiting centers (>10 patients through study).

  5. Post-operative transfusion

    Time frame: Surgery to hospital discharge (average of 7 days)

    A comparison of the number of transfusions after surgery between the groups Analysis restricted to high-volume recruiting centers (>10 patients through study).

  6. Re-exploration for bleeding

    Time frame: Surgery to hospital discharge (average of 7 days)

    The incidence of re-exploration for bleeding after surgery Analysis restricted to high-volume recruiting centers (>10 patients through study).

  7. Post-operative pain

    Time frame: Surgery to hospital discharge (average of 7 days)

    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).

  8. Duration of intubation

    Time frame: Time of arrival in the Intensive Care Unit until extubation. (average of 12 hours.)

    Comparison of the average duration of intubation between groups Analysis restricted to high-volume recruiting centers (>10 patients through study).

  9. Length of ICU stay

    Time frame: Surgery to hospital discharge (average of 7 days)

    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).

  10. Length of hospital stay

    Time frame: Surgery to hospital discharge (average of 7 days)

    Comparison of the average number of days spent in hospital between groups Analysis restricted to high-volume recruiting centers (>10 patients through study).

  11. Atrial fibrillation

    Time frame: Surgery to hospital discharge (average of 7 days)

    Incidence of new-onset atrial fibrillation after cardiac surgery Analysis restricted to high-volume recruiting centers (>10 patients through study).

  12. Wound infection

    Time frame: Surgery to 2-months post-op

    Incidence of wound infections in each group Analysis restricted to high-volume recruiting centers (>10 patients through study).

  13. Angina

    Time frame: Surgery to 4-weeks post-op

    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).

  14. Quality of Life - mental function

    Time frame: Surgery to 4-weeks post-op

    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).

Sponsors and collaborators

Lead sponsor

Ottawa Heart Institute Research Corporation

Other

Collaborators

  • Apollo Hospitals Enterprise Limited
  • Carolinas Medical Center
  • Far Eastern Memorial Hospital
  • Fortis Escorts Heart Institute
  • Fresno Heart and Surgical Hospital
  • Gundersen Lutheran Health System
  • Heart Center Leipzig - University Hospital
  • Ichinomiya-Nishi Hospital
  • Jilin Heart Hospital
  • London Health Sciences Centre
  • Medtronic
  • The Methodist Hospital Research Institute

Registry information

Official study title

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

Acronym: MIST

Important dates

Study start
2018
Primary completion
2025
Study completion
2028
First posted
Feb 27, 2018
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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