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Completed

NCT Number: NCT01842568

Vascular Events In Surgery patIents cOhort evaluatioN - Cardiac Surgery

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.

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Key information

Conditions

Vascular Death Brain Diseases Cardiac Surgery Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Prince Alfred Hospital, Sydney, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. All-cause mortality at 30-days after surgery

    Time frame: 30 days after surgery

    All-cause mortality at 30-days after surgery

  2. Myocardial injuries that were not identified clinically during the first 5 days after surgery

    Time frame: 5 days after surgery

    Myocardial injuries that were not identified clinically during the first 5 days after surgery

  3. Composite of vascular death, nonfatal myocardial infarction, nonfatal cardiac arrest, nonfatal stroke, and mechanical assist device

    Time frame: 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)

  4. Composite of vascular death, nonfatal myocardial infarction, nonfatal cardiac arrest, nonfatal stroke, and mechanical assist device

    Time frame: 1 year after surgery

    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)

Secondary outcomes

  1. Composite of vascular death, nonfatal myocardial infarction, nonfatal stroke, and mechanical assist device

    Time frame: 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)

  2. Total mortality

    Time frame: 30 days after surgery

    Total mortality

  3. Total mortality

    Time frame: 1 year after surgery

    Total mortality

  4. Vascular mortality

    Time frame: 30 days after surgery

    death due to vascular cause

  5. Vascular mortality

    Time frame: 1 year after surgery

    death due to vascular cause

  6. Myocardial infarction

    Time frame: 30 days after surgery

    Myocardial infarction

  7. Myocardial infarction

    Time frame: 1 year after surgery

    Myocardial infarction

  8. Non-fatal cardiac arrest

    Time frame: 30 days after surgery

    Non-fatal cardiac arrest

  9. Non-fatal cardiac arrest

    Time frame: 1 year after surgery

    Non-fatal cardiac arrest

  10. Stroke

    Time frame: 30 days after surgery

    Stroke

  11. Stroke

    Time frame: 1 year after surgery

    Stroke

  12. Implantation of mechanical assist device

    Time frame: 30 days after surgery

    Implantation of mechanical assist device

  13. Implantation of mechanical assist device

    Time frame: 1 year after surgery

    Implantation of mechanical assist device

  14. Cardiac transplant

    Time frame: 30 days after surgery

    Cardiac transplant

  15. Cardiac transplant

    Time frame: 1 year after surgery

    Cardiac transplant

  16. Repeat cardiac revascularization procedures

    Time frame: 30 days after surgery

    Repeat cardiac revascularization procedures

  17. Repeat cardiac revascularization procedures

    Time frame: 1 year after surgery

    Repeat cardiac revascularization procedures

  18. Congestive heart failure

    Time frame: 30 days after surgery

    Congestive heart failure

  19. Congestive heart failure

    Time frame: 1 year after surgery

    Congestive heart failure

  20. New atrial fibrillation

    Time frame: 30 days after surgery

    New clinically important atrial fibrillation

  21. New atrial fibrillation

    Time frame: 1 year after surgery

    New clinically important atrial fibrillation

  22. Pulmonary embolus

    Time frame: 30 days after surgery

    Pulmonary embolus

  23. Pulmonary embolus

    Time frame: 1 year after surgery

    Pulmonary embolus

  24. Deep venous thrombosis

    Time frame: 30 days after surgery

    Deep venous thrombosis

  25. Deep venous thrombosis

    Time frame: 1 year after surgery

    Deep venous thrombosis

  26. Major bleeding

    Time frame: 30 days after surgery

    Major bleeding

  27. Major bleeding

    Time frame: 1 year after surgery

    Major bleeding

  28. New dialysis

    Time frame: 30 days after surgery

    New dialysis

  29. New dialysis

    Time frame: 1 year after surgery

    New dialysis

  30. Infection

    Time frame: 30 days after surgery

    Infection (including sternal, sepsis, pneumonia)

  31. Infection

    Time frame: 1 year after surgery

    Infection (including sternal, sepsis, pneumonia)

  32. Re-hospitalization for a vascular reason

    Time frame: 30 days after surgery

    Re-hospitalization for a vascular reason

  33. Re-hospitalization for a vascular reason

    Time frame: 1 year after surgery

    Re-hospitalization for a vascular reason

  34. Chronic incisional pain

    Time frame: 30 days after surgery

    Chronic incisional pain

  35. Chronic incisional pain

    Time frame: 1 year after surgery

    Chronic incisional pain

  36. Frailty

    Time frame: 30 days after surgery

    Frailty assessed by PRISMA-7 questionnaire

  37. Frailty

    Time frame: 1 year after surgery

    Frailty assessed by PRISMA-7 questionnaire

Sponsors and collaborators

Lead sponsor

Population Health Research Institute

Other

Collaborators

  • Abbott Diagnostics Division

Registry information

Important dates

Study start
2013
Primary completion
2022
Study completion
2025
First posted
Apr 29, 2013
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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