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Vascular Events In Surgery patIents cOhort evaluatioN - Cardiac Surgery

Vascular Events In Surgery patIents cOhort evaluatioN - Cardiac Surgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01842568
Enrollment
15989
Registered
2013-04-29
Start date
2013-05-31
Completion date
2025-07-31
Last updated
2025-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery, Myocardial Infarction, Stroke, Vascular Death

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

Abbott Diagnostics Division
CollaboratorINDUSTRY
Population Health Research Institute
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
All-cause mortality at 30-days after surgery30 days after surgeryAll-cause mortality at 30-days after surgery
Myocardial injuries that were not identified clinically during the first 5 days after surgery5 days after surgeryMyocardial 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 device30 days after surgeryMajor 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

MeasureTime frameDescription
Myocardial infarction30 days after surgeryMyocardial infarction
Non-fatal cardiac arrest30 days after surgeryNon-fatal cardiac arrest
Stroke30 days after surgeryStroke
Implantation of mechanical assist device30 days after surgeryImplantation of mechanical assist device
Cardiac transplant30 days after surgeryCardiac transplant
Repeat cardiac revascularization procedures30 days after surgeryRepeat cardiac revascularization procedures
Congestive heart failure30 days after surgeryCongestive heart failure
New atrial fibrillation30 days after surgeryNew clinically important atrial fibrillation
Composite of vascular death, nonfatal myocardial infarction, nonfatal stroke, and mechanical assist device30 days after surgeryMajor 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 thrombosis30 days after surgeryDeep venous thrombosis
Major bleeding30 days after surgeryMajor bleeding
New dialysis30 days after surgeryNew dialysis
Infection30 days after surgeryInfection (including sternal, sepsis, pneumonia)
Re-hospitalization for a vascular reason30 days after surgeryRe-hospitalization for a vascular reason
Chronic incisional pain30 days after surgeryChronic incisional pain
Frailty30 days after surgeryFrailty assessed by PRISMA-7 questionnaire
Pulmonary embolus30 days after surgeryPulmonary embolus
Total mortality30 days after surgeryTotal mortality
Vascular mortality30 days after surgerydeath due to vascular cause

Countries

Australia, Brazil, Canada, China, Hong Kong, Italy, Malaysia, Poland, Russia, Spain, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026