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

Last updated: January 8, 2024
Sponsor: Ottawa Heart Institute Research Corporation
Overall Status: Active - Recruiting

Phase

N/A

Condition

Coronary Artery Disease

Cardiovascular Disease

Chest Pain

Treatment

MICS CABG

Conventional CABG

Clinical Study ID

NCT03447938
20180008
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18 years of age or older
  • Angiographically-confirmed multi-vessel coronary artery disease lesions with >=70% inat least 2 major epicardial vessels in 2 or more coronary artery territories (leftanterior 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 surgerythrough either median sternotomy or minimally-invasive approach.
  • Patients who are willing and able to comply with all follow-up study visits.

Exclusion

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 pulmonarydisease; hemodynamically significant left subclavian stenosis; morbid obesity; severeleft ventricular (LV) dysfunction; no adequate PDA or marginal branch target; absenceof 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 Design

Total Participants: 176
Treatment Group(s): 2
Primary Treatment: MICS CABG
Phase:
Study Start date:
September 01, 2018
Estimated Completion Date:
March 01, 2028

Connect with a study center

  • Universitaire Ziekenhuizen Leuven

    Leuven,
    Belgium

    Site Not Available

  • London Health Science Centre

    London, Ontario N6A5W9
    Canada

    Site Not Available

  • Division of Cardiac Surgery, University of Ottawa Heart Institute

    Ottawa, Ontario K1Y 4W7
    Canada

    Active - Recruiting

  • University Health Network

    Toronto, Ontario
    Canada

    Site Not Available

  • Wuhan Asia Heart Hospital

    Wuhan, Hubei Sheng 430015
    China

    Site Not Available

  • Jilin Heart Hospital

    Jilin, Jilin 130117
    China

    Active - Recruiting

  • Leipzig Heart Institute GmbH

    Leipzig, Saxony
    Germany

    Active - Recruiting

  • Robert-Bosch-Hospital

    Stuttgart,
    Germany

    Site Not Available

  • Manipal Hospitals

    New Delhi, Delhi
    India

    Site Not Available

  • Apollo Hospital, Bangalore

    Bangalore, Karnataka 560041
    India

    Active - Recruiting

  • Ichinomiya-Nishi Hospital

    Ichinomiya, Aichi
    Japan

    Site Not Available

  • Tokyo Bay Urayasu Ichikawa Medical Center

    Urayasu, Chiba
    Japan

    Site Not Available

  • National University Hospital (NUH) - Singapore

    Singapore,
    Singapore

    Active - Recruiting

  • Far-Eastern Memorial Hospital

    Taipei, 220
    Taiwan

    Site Not Available

  • Fresno Heart Hospital

    Fresno, California 93720
    United States

    Site Not Available

  • Carolinas Medical Centre

    Charlotte, North Carolina 28203
    United States

    Site Not Available

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Houston Methodist

    Houston, Texas 77030
    United States

    Site Not Available

  • Gundersen Lutheran Medical Center

    La Crosse, Wisconsin 54601
    United States

    Active - Recruiting

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