Cardiac Surgery, Myocardial Infarction, Stroke, Vascular Death
Conditions
Keywords
Cardiac surgery, Troponin, Vascular events, Myocardial injury, Observational cohort study, Public health
Brief summary
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.
Interventions
None listed
Sponsors
Study design
Eligibility
Inclusion criteria
1. Age ≥ 18 years. 2. Patients who have undergone cardiac surgery. This includes coronary artery bypass grafting and all open heart procedures such as valvular repairs/replacement.
Exclusion criteria
1. Previously enrolled in the VISION Cardiac Surgery Study. 2. Patients who have undergone an isolated pericardial window, pericardiectomy, permanent pacemaker or defibrillator implantation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality at 30-days after surgery | 30 days after surgery | All-cause mortality at 30-days after surgery |
| Myocardial injuries that were not identified clinically during the first 5 days after surgery | 5 days after surgery | Myocardial injuries that were not identified clinically during the first 5 days after surgery |
| Composite of vascular death, nonfatal myocardial infarction, nonfatal cardiac arrest, nonfatal stroke, and mechanical assist device | 30 days after surgery | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Myocardial infarction | 30 days after surgery | Myocardial infarction |
| Non-fatal cardiac arrest | 30 days after surgery | Non-fatal cardiac arrest |
| Stroke | 30 days after surgery | Stroke |
| Implantation of mechanical assist device | 30 days after surgery | Implantation of mechanical assist device |
| Cardiac transplant | 30 days after surgery | Cardiac transplant |
| Repeat cardiac revascularization procedures | 30 days after surgery | Repeat cardiac revascularization procedures |
| Congestive heart failure | 30 days after surgery | Congestive heart failure |
| New atrial fibrillation | 30 days after surgery | New clinically important atrial fibrillation |
| Composite of vascular death, nonfatal myocardial infarction, nonfatal stroke, and mechanical assist device | 30 days after surgery | Major vascular complications at 30-days after surgery (i.e., a composite of vascular death, nonfatal myocardial infarction, nonfatal stroke, and mechanical assist device) |
| Deep venous thrombosis | 30 days after surgery | Deep venous thrombosis |
| Major bleeding | 30 days after surgery | Major bleeding |
| New dialysis | 30 days after surgery | New dialysis |
| Infection | 30 days after surgery | Infection (including sternal, sepsis, pneumonia) |
| Re-hospitalization for a vascular reason | 30 days after surgery | Re-hospitalization for a vascular reason |
| Chronic incisional pain | 30 days after surgery | Chronic incisional pain |
| Frailty | 30 days after surgery | Frailty assessed by PRISMA-7 questionnaire |
| Pulmonary embolus | 30 days after surgery | Pulmonary embolus |
| Total mortality | 30 days after surgery | Total mortality |
| Vascular mortality | 30 days after surgery | death due to vascular cause |
Countries
Australia, Brazil, Canada, China, Hong Kong, Italy, Malaysia, Poland, Russia, Spain, United Kingdom, United States