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NCT Number: NCT04973397

Vascular Events In Patients Undergoing Same-day Noncardiac Surgery (VALIANCE) Study

The proportion of noncardiac surgeries performed as same-day surgery is increasing worldwide, with more complex surgeries being performed on higher risk patients in the outpatient setting. Little is known on the risk factors, incidence and prognosis of patients undergoing same-day noncardiac surgery. The main objective of this study is to inform on the incidence and risk factors of cardiovascular and other adverse events after same-day surgery and to develop risk prediction tools to better inform on the risk and selection of patients undergoing same-day surgery.

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Key information

Conditions

Preoperative Care Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgery--Complications Vascular Diseases

Age range

45 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hamilton General Hospital, Hamilton, Ontario, Canada

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About this study

The VALIANCE Study is a 15,000 patient, multicentre, prospective observational cohort of adults undergoing elective same-day noncardiac surgery and who will be followed for 90 days after surgery. The primary objective of the study is to determine the incidence of major cardiovascular complications after same-day surgery. Patients will also be followed for the occurence of other adverse postoperative complications and determine their change in quality of life at 90 days after surgery. VALIANCE will inform on the risk factors for postoperative complications and allow to develop risk prediction tools to guide patient selection and risk stratification of patients undergoing same-day surgery. The study will also look at validating the use of the Duke Activity Status Index questionnaire, Clinical Frailty Scale, and the Revised Cardiac Risk Index. Postoperative pain will be evaluated using the Brief pain inventory score and quality of life using the EQ-5D-5L questionnaire.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 45-64 years of age with at least one risk factor, or ≥65 years of age;
  • undergoing elective noncardiac same-day surgery;
  • planned duration in the operating room 60 minutes or more;
  • provided written consent.

Exclusion criteria

  • intervention does not require the presence of an anesthesiologist;
  • procedure is performed by a nonsurgical specialty (e.g., gastroenterology, pneumology, radio-oncology or radiology);
  • intervention is an ophthalmologic procedure;
  • previously enrolled in the VALIANCE study.

Treatment and study plan

Primary outcomes

  1. Unplanned healthcare utilization

    Time frame: 90 days

    the number of patients who have at least one of the following: unplanned admission after surgery, unplanned outpatient visit, emergency room visit and rehospitalization after same-day surgery

Secondary outcomes

  1. unplanned admission

    Time frame: 90 days

    the number of patients who have to be admitted to the hospital after undergoing a surgery planned as same-day

  2. unplanned outpatient visit

    Time frame: 90 days

    the number of patient who had a medical visit in an outpatient setting after undergoing same-day surgery

  3. emergency room visit

    Time frame: 90 days

    the number of patients who visited the emergency room without subsequent hospitalization after undergoing same-day surgery

  4. re-hospitalization

    Time frame: 90 days

    the number of patients who have to be readmitted to the hospital after being discharged home following their same-day surgery

  5. major cardiovascular complications

    Time frame: 90 days

    the number of patients who have at least one of the following: myocardial injury or infarction, non-fatal cardiac arrest, coronary revascularization, stroke, transient ischemic attack, new clinically significant arrythmia, congestive heart failure, unplanned postoperative admission for vascular reasons, emergency room visit for vascular reasons, rehospitalization for vascular reasons, and all-cause mortality

  6. myocardial injury after noncardiac surgery (MINS)

    Time frame: 90 days

    the number of patients who experience a MINS

  7. myocardial infarction

    Time frame: 90 days

    the number of patients who experience a myocardial infarction

  8. non-fatal cardiac arrest

    Time frame: 90 days

    the number of patients who experience a non-fatal cardiac arrest

  9. coronary revascularization

    Time frame: 90 days

    the number of patients who undergo coronary revascularization

  10. stroke

    Time frame: 90 days

    the number of patients who experience a stroke

  11. transient ischemic attack

    Time frame: 90 days

    the number of patients who experience a transient ischemic attack

  12. new clinically important arrythmia

    Time frame: 90 days

    the number of patients who experience a new clinically important arrythmia

  13. acute congestive heart failure

    Time frame: 90 days

    the number of patients who experience an acute congestive heart failure episode

  14. deep vein thrombosis

    Time frame: 90 days

    the number of patients who experience a deep vein thrombosis

  15. pulmonary embolism

    Time frame: 90 days

    the number of patients who experience a pulmonary embolism

  16. major postoperative and life-threatening bleeding

    Time frame: 90 days

    the number of patients who experience a major postoperative and/or life-threatening bleeding

  17. postoperative infection

    Time frame: 90 days

    the number of patients who experience a postoperative infection

  18. acute kidney injury

    Time frame: 90 days

    the number of patients who experience a acute kidney injury

  19. quality of life score on the 5-level EQ-5D version (EQ-5D-5L) questionnaire

    Time frame: 90 days

    score on the EQ-5D-5L questionnaire on 4 health profiles (level 1 to 5), overall self-rated health status (0-100 visual analogue scale), and EQ-5D-5L index value (0.01-0.99)

  20. functional capacity score on the Duke Activity Status Index (DASI)

    Time frame: 90 days

    change in the score on the Duke Activity Status Index (DASI) questionnaire (0 to 58.2 points)

  21. frailty

    Time frame: 90 days

    change in the level on the Clinical Frailty Scale (level 1 to 9)

Study contacts

Contact information is provided by the study sponsor or research team.

Melodie Fanay Boko, MSc

CONTACT

[email protected]

514-890-8000 ext. 31541

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • Fonds de la Recherche en Santé du Québec
  • Université de Montréal

Registry information

Official study title

Vascular Events In Patients Undergoing Same-day Noncardiac Surgery (VALIANCE) Study - A Prospective Observational Cohort Study Evaluating Major Cardiovascular and Adverse Events in Patients Undergoing Elective Same-day Noncardiac Surgery

Acronym: VALIANCE

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Jul 22, 2021
Registry last updated
Mar 19, 2026

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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