Clinical trial NCT03447938: The Minimally Invasive Coronary Surgery Compared to STernotomy Coronary Artery Bypass Grafting Trial
Official title: The Minimally Invasive Coronary Surgery Compared to STernotomy Coronary Artery Bypass Grafting Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
Collaborators: name: London Health Sciences Centre
name: Heart Center Leipzig - University Hospital
name: Fortis Escorts Heart Institute
name: The Methodist Hospital Research Institute
name: Carolinas Medical Center
name: Gundersen Lutheran Health System
name: Jilin Heart Hospital
name: Far Eastern Memorial Hospital
name: Medtronic
name: Apollo Hospitals Enterprise Limited
name: Fresno Heart and Surgical Hospital
name: Ichinomiya-Nishi Hospital
First posted: 2018-02-27
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Quality of life - physical function
timeFrame: 4 weeks after surgery
Secondary outcomes:
measure: Major Adverse Cardiac and Cerebrovascular Events (MACCE) and Target Vessel Revascularization (TVR)
timeFrame: Through study completion, an average of 1 year after surgery.
measure: Number of bypass grafts
timeFrame: During coronary artery bypass surgery
measure: Percentage of arterial grafts
timeFrame: During coronary artery bypass surgery
measure: Intra-operative transfusion
timeFrame: During coronary artery bypass surgery
measure: Post-operative transfusion
timeFrame: From the time of surgery until the patient is discharged from hospital, an average of 7 days
measure: Re-exploration for bleeding
timeFrame: From the time of surgery until the patient is discharged from hospital, an average of 7 days
measure: Post-operative pain
timeFrame: From the time of surgery until the patient is discharged from hospital, an average of 7 days
measure: Duration of intubation
timeFrame: Measured from the time of arrival in the Intensive Care Unit until the time patients are extubated, an average of 12 hours.
measure: Length of ICU stay
timeFrame: From the time of surgery until the patient is discharged from hospital, an average of 7 days
measure: Length of hospital stay
timeFrame: From the time of surgery until the patient is discharged from hospital, an average of 7 days
measure: Atrial fibrillation
timeFrame: From the time of surgery until the patient is discharged from hospital, an average of 7 days
measure: Wound infection
timeFrame: During the first 2 months after surgery
measure: Angina
timeFrame: 4 weeks after surgery
measure: Quality of Life - mental function
timeFrame: 4 weeks after surgery
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: La Crosse
country: United States
facility: Gundersen Lutheran Medical Center
state: Wisconsin
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen Leuven
city: Ottawa
country: Canada
facility: Division of Cardiac Surgery, University of Ottawa Heart Institute
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
city: Jilin
country: China
facility: Jilin Heart Hospital
state: Jilin
city: Leipzig
country: Germany
facility: Leipzig Heart Institute GmbH
state: Saxony
city: Stuttgart
country: Germany
facility: Robert-Bosch-Hospital
city: New Delhi
country: India
facility: Manipal Hospitals
state: Delhi
city: Bangalore
country: India
facility: Apollo Hospital, Bangalore
state: Karnataka
city: Urayasu
country: Japan
facility: Tokyo Bay Urayasu Ichikawa Medical Center
state: Chiba
city: Singapore
country: Singapore
facility: National University Hospital (NUH) - Singapore
city: Taipei
country: Taiwan
facility: Far-Eastern Memorial Hospital
Study officials:
affiliation: Ottawa Heart Institute Research Corporation
name: Marc Ruel, MD
role: PRINCIPAL_INVESTIGATOR
References: