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

NCT03447938 | Recruiting DMC

• 1 other identifier: 20180008
• Study Type: interventional
• Target: 176
• Locations: 9 countries
• Sites: 13

Brief 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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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 generaly health perceptions.

  4 weeks after surgery

Secondary Outcomes (14)

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

  Through study completion, an average of 1 year after surgery.

• Number of bypass grafts

  During coronary artery bypass surgery

• Percentage of arterial grafts

  During coronary artery bypass surgery

• Intra-operative transfusion

  During coronary artery bypass surgery

• Post-operative transfusion

  From the time of surgery until the patient is discharged from hospital, an average of 7 days

Study Arms (2)

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).

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.

Procedure: MICS CABG

Interventions

MICS CABG PROCEDURE

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

Also known as: Minimally invasive coronary artery bypass grafting

Minimally-invasive CABG

Conventional CABG PROCEDURE

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

Also known as: coronary artery bypass grafting via sternotomy

CABG with sternotomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \<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.

Sponsors & Collaborators

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

Study Sites (13)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

NOT YET RECRUITING

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, 54601, United States

RECRUITING

Universitaire Ziekenhuizen Leuven

Leuven, Belgium

NOT YET RECRUITING

Division of Cardiac Surgery, University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

RECRUITING

University Health Network

Toronto, Ontario, Canada

NOT YET RECRUITING

Jilin Heart Hospital

Jilin, Jilin, 130117, China

RECRUITING

Leipzig Heart Institute GmbH

Leipzig, Saxony, Germany

RECRUITING

Robert-Bosch-Hospital

Stuttgart, Germany

NOT YET RECRUITING

Apollo Hospital, Bangalore

Bangalore, Karnataka, 560041, India

RECRUITING

Manipal Hospitals

New Delhi, National Capital Territory of Delhi, India

NOT YET RECRUITING

Tokyo Bay Urayasu Ichikawa Medical Center

Urayasu, Chiba, Japan

NOT YET RECRUITING

National University Hospital (NUH) - Singapore

Singapore, Singapore

RECRUITING

Far-Eastern Memorial Hospital

Taipei, 220, Taiwan

NOT YET RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Marc Ruel, MD

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary Zhang, MD, PhD

CONTACT

613-696-7230; mzhang@ottawaheart.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2018
• First Posted: February 27, 2018
• Study Start: September 1, 2018
• Primary Completion: March 1, 2026
• Study Completion (Estimated): March 1, 2028
• Last Updated: January 10, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2); BE (1); US (2); CA (2); JP (1); TW (1); SG (1); CN (1); IN (2)