Vascular Events In Surgery patIents cOhort evaluatioN - Cardiac Surgery

Study Overview
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Brief Summary
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Worldwide over 2 million adults (>30,000 Canadians) undergo heart surgery annually. Although heart surgery provides important survival benefits, it is associated with potential major complications such as death, stroke, and heart attack. There is promising evidence that measurement of heart injury markers after surgery will identify patients at risk of death or major complications. This study will determine the current incidence of major complications in a representative sample of 15,000 contemporary adult patients undergoing heart surgery. Knowing the current burden of complications will inform clinicians, administrators, government and granting agencies about resources required to address the problem. This study will also establish the role of measuring heart injury markers to identify important heart injury after heart surgery and the proportion that would go undetected without routine heart injury marker monitoring. This information will facilitate further studies of timely interventions. In summary, the VISION Cardiac Surgery Study addresses fundamental questions that will have profound public health implications given the millions of adults worldwide who undergo heart surgery annually.

Official Title
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Vascular Events In Surgery patIents cOhort evaluatioN - Cardiac Surgery

Conditions
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Vascular Death, Myocardial Infarction, Stroke, Cardiac Surgery

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years. Patients who have undergone cardiac surgery. This includes coronary artery bypass grafting and all open heart procedures such as valvular repairs/replacement. Exclusion Criteria: Previously enrolled in the VISION Cardiac Surgery Study. Patients who have undergone an isolated pericardial window, pericardiectomy, permanent pacemaker or defibrillator implantation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality at 30-days after surgery | All-cause mortality at 30-days after surgery | 30 days after surgery | 
| Myocardial injuries that were not identified clinically during the first 5 days after surgery | Myocardial injuries that were not identified clinically during the first 5 days after surgery | 5 days after surgery | 
| Composite of vascular death, nonfatal myocardial infarction, nonfatal cardiac arrest, nonfatal stroke, and mechanical assist device | Major vascular complications at 30 days after surgery (i.e., a composite of vascular death, nonfatal myocardial infarction, nonfatal cardiac arrest, nonfatal stroke, and mechanical assist device) | 30 days after surgery | 
| Composite of vascular death, nonfatal myocardial infarction, nonfatal cardiac arrest, nonfatal stroke, and mechanical assist device | Major vascular complications at 1-year after surgery (i.e., a composite of vascular death, nonfatal myocardial infarction, nonfatal cardiac arrest, nonfatal stroke, and mechanical assist device) | 1 year after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of vascular death, nonfatal myocardial infarction, nonfatal stroke, and mechanical assist device | Major vascular complications at 30-days after surgery (i.e., a composite of vascular death, nonfatal myocardial infarction, nonfatal stroke, and mechanical assist device) | 30 days after surgery | 
| Total mortality | Total mortality | 30 days after surgery | 
| Total mortality | Total mortality | 1 year after surgery | 
| Vascular mortality | death due to vascular cause | 30 days after surgery | 
| Vascular mortality | death due to vascular cause | 1 year after surgery | 
| Myocardial infarction | Myocardial infarction | 30 days after surgery | 
| Myocardial infarction | Myocardial infarction | 1 year after surgery | 
| Non-fatal cardiac arrest | Non-fatal cardiac arrest | 30 days after surgery | 
| Non-fatal cardiac arrest | Non-fatal cardiac arrest | 1 year after surgery | 
| Stroke | Stroke | 30 days after surgery | 
| Stroke | Stroke | 1 year after surgery | 
| Implantation of mechanical assist device | Implantation of mechanical assist device | 30 days after surgery | 
| Implantation of mechanical assist device | Implantation of mechanical assist device | 1 year after surgery | 
| Cardiac transplant | Cardiac transplant | 30 days after surgery | 
| Cardiac transplant | Cardiac transplant | 1 year after surgery | 
| Repeat cardiac revascularization procedures | Repeat cardiac revascularization procedures | 30 days after surgery | 
| Repeat cardiac revascularization procedures | Repeat cardiac revascularization procedures | 1 year after surgery | 
| Congestive heart failure | Congestive heart failure | 30 days after surgery | 
| Congestive heart failure | Congestive heart failure | 1 year after surgery | 
| New atrial fibrillation | New clinically important atrial fibrillation | 30 days after surgery | 
| New atrial fibrillation | New clinically important atrial fibrillation | 1 year after surgery | 
| Pulmonary embolus | Pulmonary embolus | 30 days after surgery | 
| Pulmonary embolus | Pulmonary embolus | 1 year after surgery | 
| Deep venous thrombosis | Deep venous thrombosis | 30 days after surgery | 
| Deep venous thrombosis | Deep venous thrombosis | 1 year after surgery | 
| Major bleeding | Major bleeding | 30 days after surgery | 
| Major bleeding | Major bleeding | 1 year after surgery | 
| New dialysis | New dialysis | 30 days after surgery | 
| New dialysis | New dialysis | 1 year after surgery | 
| Infection | Infection (including sternal, sepsis, pneumonia) | 30 days after surgery | 
| Infection | Infection (including sternal, sepsis, pneumonia) | 1 year after surgery | 
| Re-hospitalization for a vascular reason | Re-hospitalization for a vascular reason | 30 days after surgery | 
| Re-hospitalization for a vascular reason | Re-hospitalization for a vascular reason | 1 year after surgery | 
| Chronic incisional pain | Chronic incisional pain | 30 days after surgery | 
| Chronic incisional pain | Chronic incisional pain | 1 year after surgery | 
| Frailty | Frailty assessed by PRISMA-7 questionnaire | 30 days after surgery | 
| Frailty | Frailty assessed by PRISMA-7 questionnaire | 1 year after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac surgery, Troponin, Vascular events, Myocardial injury, Observational cohort study, Public health