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

Coronary Artery Disease Clinical Trial

— MIST  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03447938
• Other study ID #: 20180008
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: March 1, 2028

Study information

• Verified date: January 2024
• Source: Ottawa Heart Institute Research Corporation
• Contact: Mary Zhang, MD, PhD
• Phone: 613-696-7230
• Email: mzhang[@]ottawaheart.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 176
• Est. completion date: March 1, 2028
• Est. primary completion date: March 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Belgium	Universitaire Ziekenhuizen Leuven	Leuven
Canada	Division of Cardiac Surgery, University of Ottawa Heart Institute	Ottawa	Ontario
Canada	University Health Network	Toronto	Ontario
China	Jilin Heart Hospital	Jilin	Jilin
Germany	Leipzig Heart Institute GmbH	Leipzig	Saxony
Germany	Robert-Bosch-Hospital	Stuttgart
India	Apollo Hospital, Bangalore	Bangalore	Karnataka
India	Manipal Hospitals	New Delhi	Delhi
Japan	Tokyo Bay Urayasu Ichikawa Medical Center	Urayasu	Chiba
Singapore	National University Hospital (NUH) - Singapore	Singapore
Taiwan	Far-Eastern Memorial Hospital	Taipei
United States	Gundersen Lutheran Medical Center	La Crosse	Wisconsin
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (13)

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

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  China,  Germany,  India,  Japan,  Singapore,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Major Adverse Cardiac and Cerebrovascular Events (MACCE) and Target Vessel Revascularization (TVR)	A composite endpoint of mortality, peri-operative myocardial infarction, non-peri-operative myocardial infarction, stroke, and new CABG or PCI associated with documented ischemia.	Through study completion, an average of 1 year after surgery.
Secondary	Number of bypass grafts	A comparison of the mean number of bypass grafts performed between the two groups	During coronary artery bypass surgery
Secondary	Percentage of arterial grafts	A comparison of the percentage of bypass grafts that are arterial between the groups	During coronary artery bypass surgery
Secondary	Intra-operative transfusion	A comparison of the number of transfusions during surgery between the groups	During coronary artery bypass surgery
Secondary	Post-operative transfusion	A comparison of the number of transfusions after surgery between the groups	From the time of surgery until the patient is discharged from hospital, an average of 7 days
Secondary	Re-exploration for bleeding	The incidence of re-exploration for bleeding after surgery	From the time of surgery until the patient is discharged from hospital, an average of 7 days
Secondary	Post-operative pain	Measurement of patient's subjective assessment of their pain after surgery using a visual analog scale	From the time of surgery until the patient is discharged from hospital, an average of 7 days
Secondary	Duration of intubation	Comparison of the average duration of intubation between groups	Measured from the time of arrival in the Intensive Care Unit until the time patients are extubated, an average of 12 hours.
Secondary	Length of ICU stay	Comparison of the average number of days spent in Intensive Care Unit between groups	From the time of surgery until the patient is discharged from hospital, an average of 7 days
Secondary	Length of hospital stay	Comparison of the average number of days spent in hospital between groups	From the time of surgery until the patient is discharged from hospital, an average of 7 days
Secondary	Atrial fibrillation	Incidence of new-onset atrial fibrillation after cardiac surgery	From the time of surgery until the patient is discharged from hospital, an average of 7 days
Secondary	Wound infection	Incidence of wound infections in each group	During the first 2 months after surgery
Secondary	Angina	Prevalence of anginal symptoms, as measured by the Seattle Angina Questionnaire. The SAQ includes scales that measure physical limitation, stability of angina, frequency of angina, satisfaction with treatment, and perception of disease, each of which is measured on a scale of 0 to 100 where higher scores indicate better function or health.	4 weeks after surgery
Secondary	Quality of Life - mental function	Comparison of the mental quality of life between the two groups four weeks after surgery using the mental component score of the 36-Item Short Form Health Survey (SF-36). The mental function score is a scale from 0 (poor mental quality of life) to 100 (excellent mental quality of life), with an average score of 50. It includes items that assess vitality, general health perceptions, emotional role functioning, social role functioning, and mental health.	4 weeks after surgery