RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2018-09-01
Study Completion:2028-03-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03447938

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 years of age or older
  2. * 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)
  3. * Patients who, in the opinion of the investigator, are amenable for coronary surgery through either median sternotomy or minimally-invasive approach.
  4. * Patients who are willing and able to comply with all follow-up study visits.
  1. * \<18 years of age
  2. * concomitant cardiac procedure with CABG (e.g. valve repair or replacement)
  3. * Previous cardiac surgery, mediastinal irradiation, or significant trauma to the chest
  4. * 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.
  5. * Contraindications for conventional CABG via sternotomy
  6. * Concomitant life-threatening disease likely to limit life expectancy to \<2 years
  7. * Emergency CABG with hemodynamic compromise
  8. * Inability to provide informed consent.

Contacts and Locations

Study Contact

Mary Zhang, MD, PhD
CONTACT
613-696-7230
mzhang@ottawaheart.ca

Principal Investigator

Marc Ruel, MD
PRINCIPAL_INVESTIGATOR
Ottawa Heart Institute Research Corporation

Study Locations (Sites)

University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601
United States

Collaborators and Investigators

Sponsor: Ottawa Heart Institute Research Corporation

  • Marc Ruel, MD, PRINCIPAL_INVESTIGATOR, Ottawa Heart Institute Research Corporation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-09-01
Study Completion Date2028-03-01

Study Record Updates

Study Start Date2018-09-01
Study Completion Date2028-03-01

Terms related to this study

Additional Relevant MeSH Terms

  • Coronary Artery Disease