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Trial record 100 of 245 for:    "ottawa heart institute"

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

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ClinicalTrials.gov Identifier: NCT03447938
Recruitment Status : Enrolling by invitation
First Posted : February 27, 2018
Last Update Posted : May 24, 2018
Sponsor:
Collaborators:
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
Fresno Heart and Surgical Hospital
Medtronic
Apollo Hospitals
Ichinomiya-Nishi Hospital
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Procedure: MICS CABG Procedure: Conventional CABG Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Minimally Invasive Coronary Surgery Compared to STernotomy Coronary Artery Bypass Grafting Randomized Controlled Trial
Actual Study Start Date : May 18, 2018
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : April 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: CABG with sternotomy
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
Coronary artery bypass grafting performed through an incision through the sternum or breastbone.
Other Name: coronary artery bypass grafting via sternotomy

Experimental: Minimally-invasive CABG
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
Coronary artery bypass grafting performed through small incisions between the ribs.
Other Name: Minimally invasive coronary artery bypass grafting




Primary Outcome Measures :
  1. Quality of life - physical function [ Time Frame: 4 weeks after surgery ]
    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.


Secondary Outcome Measures :
  1. Major Adverse Cardiac and Cerebrovascular Events (MACCE) and Target Vessel Revascularization (TVR) [ Time Frame: Through study completion, an average of 1 year after surgery. ]
    A composite endpoint of mortality, peri-operative myocardial infarction, non-peri-operative myocardial infarction, stroke, and new CABG or PCI associated with documented ischemia.

  2. Number of bypass grafts [ Time Frame: During coronary artery bypass surgery ]
    A comparison of the mean number of bypass grafts performed between the two groups

  3. Percentage of arterial grafts [ Time Frame: During coronary artery bypass surgery ]
    A comparison of the percentage of bypass grafts that are arterial between the groups

  4. Intra-operative transfusion [ Time Frame: During coronary artery bypass surgery ]
    A comparison of the number of transfusions during surgery between the groups

  5. Post-operative transfusion [ Time Frame: From the time of surgery until the patient is discharged from hospital, an average of 7 days ]
    A comparison of the number of transfusions after surgery between the groups

  6. Re-exploration for bleeding [ Time Frame: From the time of surgery until the patient is discharged from hospital, an average of 7 days ]
    The incidence of re-exploration for bleeding after surgery

  7. Post-operative pain [ Time Frame: From the time of surgery until the patient is discharged from hospital, an average of 7 days ]
    Measurement of patient's subjective assessment of their pain after surgery using a visual analog scale

  8. Duration of intubation [ Time Frame: Measured from the time of arrival in the Intensive Care Unit until the time patients are extubated, an average of 12 hours. ]
    Comparison of the average duration of intubation between groups

  9. Length of ICU stay [ Time Frame: From the time of surgery until the patient is discharged from hospital, an average of 7 days ]
    Comparison of the average number of days spent in Intensive Care Unit between groups

  10. Length of hospital stay [ Time Frame: From the time of surgery until the patient is discharged from hospital, an average of 7 days ]
    Comparison of the average number of days spent in hospital between groups

  11. Atrial fibrillation [ Time Frame: From the time of surgery until the patient is discharged from hospital, an average of 7 days ]
    Incidence of new-onset atrial fibrillation after cardiac surgery

  12. Wound infection [ Time Frame: During the first 2 months after surgery ]
    Incidence of wound infections in each group

  13. Angina [ Time Frame: 4 weeks after surgery ]
    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.

  14. Quality of Life - mental function [ Time Frame: 4 weeks after surgery ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03447938


Locations
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United States, California
Fresno Heart Hospital
Fresno, California, United States, 93720
United States, North Carolina
Carolinas Medical Centre
Charlotte, North Carolina, United States, 28203
United States, Texas
Houston Methodist
Houston, Texas, United States, 77030
United States, Wisconsin
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States, 54601
Canada, Ontario
London Health Science Centre
London, Ontario, Canada, N6A5W9
Division of Cardiac Surgery, University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
China, Hubei Sheng
Wuhan Asia Heart Hospital
Wuhan, Hubei Sheng, China, 430015
China, Jilin
Jilin Heart Hospital
Jilin, Jilin, China, 130117
Germany
Leipzig Heart Institute GmbH
Leipzig, Saxony, Germany
India
Fortis Escorts Heart Institute
New Delhi, Delhi, India, 110025
Apollo Hospital, Bangalore
Bangalore, Karnataka, India, 560041
Japan
Ichinomiya-Nishi Hospital
Ichinomiya, Aichi, Japan
Taiwan
Far-Eastern Memorial Hospital
Taipei, Taiwan, 220
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
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
Fresno Heart and Surgical Hospital
Medtronic
Apollo Hospitals
Ichinomiya-Nishi Hospital
Investigators
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Principal Investigator: Marc Ruel, MD Ottawa Heart Institute Research Corporation

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Responsible Party: Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT03447938     History of Changes
Other Study ID Numbers: 20180008
First Posted: February 27, 2018    Key Record Dates
Last Update Posted: May 24, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will not be made available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases