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| Name | Class |
|---|---|
| London Health Sciences Centre | OTHER |
| Heart Center Leipzig - University Hospital | OTHER |
| Fortis Escorts Heart Institute | OTHER |
| The Methodist Hospital Research Institute |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MICS CABG | Procedure | Coronary artery bypass grafting performed through small incisions between the ribs. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 generally health perceptions. Analysis restricted to high-volume recruiting centers (>10 patients through study). | Surgery to 4 weeks post-op |
| Measure | Description | Time Frame |
|---|---|---|
| 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. Analysis restricted to high-volume recruiting centers (>10 patients through study). | Surgery to study completion (average of 1 year after surgery.) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc Ruel, MD | Ottawa Heart Institute Research Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States | ||
| Gundersen Lutheran Medical Center |
Individual participant data will not be made available to other researchers.
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| OTHER |
| Carolinas Medical Center | OTHER |
| Gundersen Lutheran Health System | OTHER |
| Jilin Heart Hospital | OTHER |
| Far Eastern Memorial Hospital | OTHER |
| Medtronic | INDUSTRY |
| Apollo Hospitals Enterprise Limited | OTHER |
| Fresno Heart and Surgical Hospital | UNKNOWN |
| Ichinomiya-Nishi Hospital | UNKNOWN |
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| Conventional CABG | Procedure | Coronary artery bypass grafting performed through an incision through the sternum or breastbone. |
|
|
| Number of bypass grafts | A comparison of the mean number of bypass grafts performed between the two groups Analysis restricted to high-volume recruiting centers (>10 patients through study). | During coronary artery bypass surgery |
| Percentage of arterial grafts | A comparison of the percentage of bypass grafts that are arterial between the groups. Analysis restricted to high-volume recruiting centers (>10 patients through study). | During coronary artery bypass surgery |
| Intra-operative transfusion | A comparison of the number of transfusions during surgery between the groups Analysis restricted to high-volume recruiting centers (>10 patients through study). | During coronary artery bypass surgery |
| Post-operative transfusion | A comparison of the number of transfusions after surgery between the groups Analysis restricted to high-volume recruiting centers (>10 patients through study). | Surgery to hospital discharge (average of 7 days) |
| Re-exploration for bleeding | The incidence of re-exploration for bleeding after surgery Analysis restricted to high-volume recruiting centers (>10 patients through study). | Surgery to hospital discharge (average of 7 days) |
| Post-operative pain | Measurement of patient's subjective assessment of their pain after surgery using a visual analog scale Analysis restricted to high-volume recruiting centers (>10 patients through study). | Surgery to hospital discharge (average of 7 days) |
| Duration of intubation | Comparison of the average duration of intubation between groups Analysis restricted to high-volume recruiting centers (>10 patients through study). | Time of arrival in the Intensive Care Unit until extubation. (average of 12 hours.) |
| Length of ICU stay | Comparison of the average number of days spent in Intensive Care Unit between groups Analysis restricted to high-volume recruiting centers (>10 patients through study). | Surgery to hospital discharge (average of 7 days) |
| Length of hospital stay | Comparison of the average number of days spent in hospital between groups Analysis restricted to high-volume recruiting centers (>10 patients through study). | Surgery to hospital discharge (average of 7 days) |
| Atrial fibrillation | Incidence of new-onset atrial fibrillation after cardiac surgery Analysis restricted to high-volume recruiting centers (>10 patients through study). | Surgery to hospital discharge (average of 7 days) |
| Wound infection | Incidence of wound infections in each group Analysis restricted to high-volume recruiting centers (>10 patients through study). | Surgery to 2-months post-op |
| 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. Analysis restricted to high-volume recruiting centers (>10 patients through study). | Surgery to 4-weeks post-op |
| 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. Analysis restricted to high-volume recruiting centers (>10 patients through study). | Surgery to 4-weeks post-op |
| La Crosse |
| Wisconsin |
| 54601 |
| United States |
| Universitaire Ziekenhuizen Leuven | Leuven | Belgium |
| Division of Cardiac Surgery, University of Ottawa Heart Institute | Ottawa | Ontario | K1Y 4W7 | Canada |
| University Health Network | Toronto | Ontario | Canada |
| Jilin Heart Hospital | Jilin City | Jilin | 130117 | China |
| Leipzig Heart Institute GmbH | Leipzig | Saxony | Germany |
| Robert-Bosch-Hospital | Stuttgart | Germany |
| Apollo Hospital, Bangalore | Bangalore | Karnataka | 560041 | India |
| Manipal Hospitals | New Delhi | National Capital Territory of Delhi | India |
| Tokyo Bay Urayasu Ichikawa Medical Center | Urayasu | Chiba | Japan |
| National University Hospital (NUH) - Singapore | Singapore | Singapore |
| Far-Eastern Memorial Hospital | Taipei | Taipei | 220 | Taiwan |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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