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

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

Sponsors

Lead sponsor: Ottawa Heart Institute Research Corporation

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

Source Ottawa Heart Institute Research Corporation
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.

Overall Status Recruiting
Start Date September 1, 2018
Completion Date March 1, 2025
Primary Completion Date March 1, 2022
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Quality of life - physical function 4 weeks after surgery
Secondary Outcome
Measure Time Frame
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
Re-exploration for bleeding From the time of surgery until the patient is discharged from hospital, an average of 7 days
Post-operative pain From the time of surgery until the patient is discharged from hospital, an average of 7 days
Duration of intubation Measured from the time of arrival in the Intensive Care Unit until the time patients are extubated, an average of 12 hours.
Length of ICU stay From the time of surgery until the patient is discharged from hospital, an average of 7 days
Length of hospital stay From the time of surgery until the patient is discharged from hospital, an average of 7 days
Atrial fibrillation From the time of surgery until the patient is discharged from hospital, an average of 7 days
Wound infection During the first 2 months after surgery
Angina 4 weeks after surgery
Quality of Life - mental function 4 weeks after surgery
Enrollment 176
Condition
Intervention

Intervention type: Procedure

Intervention name: MICS CABG

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

Arm group label: Minimally-invasive CABG

Other name: Minimally invasive coronary artery bypass grafting

Intervention type: Procedure

Intervention name: Conventional CABG

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

Arm group label: CABG with sternotomy

Other name: coronary artery bypass grafting via sternotomy

Eligibility

Criteria:

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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Marc Ruel, MD Principal Investigator Ottawa Heart Institute Research Corporation
Overall Contact

Last name: Suzanne Crowe, CCRP

Phone: 613-696-7000

Phone ext: 10656

Email: [email protected]

Location
facility status contact
Fresno Heart Hospital | Fresno, California, 93720, United States Not yet recruiting Pervais Chaudhry, MD
Carolinas Medical Centre | Charlotte, North Carolina, 28203, United States Not yet recruiting Joe McGinn, MD
Houston Methodist | Houston, Texas, 77030, United States Not yet recruiting LaShawna Green, RN Mahesh Ramchandani, MD Principal Investigator
Gundersen Lutheran Medical Center | La Crosse, Wisconsin, 54601, United States Not yet recruiting Prem Rabindra, MD
London Health Science Centre | London, Ontario, N6A5W9, Canada Not yet recruiting Bob Kiaii, MD
Division of Cardiac Surgery, University of Ottawa Heart Institute | Ottawa, Ontario, K1Y 4W7, Canada Recruiting Marc Ruel, MD MPH FRCSC 613-761-4893 [email protected]
Wuhan Asia Heart Hospital | Wuhan, Hubei Sheng, 430015, China Not yet recruiting Keita Kikuchi, MD
Jilin Heart Hospital | Jilin, Jilin, 130117, China Not yet recruiting Massimo Lemma, MD
Leipzig Heart Institute GmbH | Leipzig, Saxony, Germany Not yet recruiting Anne-Kathrin Funkat [email protected] Piroze Davierwala, MD Principal Investigator
Fortis Escorts Heart Institute | New Delhi, Delhi, 110025, India Not yet recruiting Yugal Mishra, MD
Apollo Hospital, Bangalore | Bangalore, Karnataka, 560041, India Not yet recruiting Sathyaki Nambala
Ichinomiya-Nishi Hospital | Ichinomiya, Aichi, Japan Not yet recruiting Keita Kikuchi, MD 0586480077 [email protected]
Far-Eastern Memorial Hospital | Taipei, 220, Taiwan Not yet recruiting Kuan-Ming Chiu, MD
Location Countries

Canada

China

Germany

India

Japan

Taiwan

United States

Verification Date

June 2020

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: CABG with sternotomy

Arm group type: Active Comparator

Description: 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).

Arm group label: Minimally-invasive CABG

Arm group type: Experimental

Description: Patients in this group will undergo coronary artery bypass grafting (CABG) using a minimally-invasive approach (MICS CABG), through smaller incisions between the ribs.

Acronym MIST
Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Single (Outcomes Assessor)

Source: ClinicalTrials.gov