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Active, not recruiting Not applicable

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

NCT03447938 · tracked via the Priya Life Science India tracker
Phase
Not applicable
Started
2018-09-01
Last updated
2026-05-12

Condition(s) studied

Coronary Artery Disease

Investigational drug(s) / intervention(s)

MICS CABGConventional CABG

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

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

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Quality of life - physical function — 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).

Trial sites (13)

FacilityCityRegionStatus
University of Pittsburgh Medical Center Pittsburgh Pennsylvania
Gundersen Lutheran Medical Center La Crosse Wisconsin
Universitaire Ziekenhuizen Leuven Leuven Belgium
Division of Cardiac Surgery, University of Ottawa Heart Institute Ottawa Ontario
University Health Network Toronto Ontario
Jilin Heart Hospital Jilin City Jilin
Leipzig Heart Institute GmbH Leipzig Saxony
Robert-Bosch-Hospital Stuttgart Germany
Apollo Hospital, Bangalore Bangalore Karnataka
Manipal Hospitals New Delhi National Capital Territory of Delhi
Tokyo Bay Urayasu Ichikawa Medical Center Urayasu Chiba
National University Hospital (NUH) - Singapore Singapore Singapore
Far-Eastern Memorial Hospital Taipei Taipei
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03447938 on ClinicalTrials.gov ↗ ← All trials in India