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

Last updated: April 22, 2025
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Overall Status: Active - Recruiting

Phase

N/A

Condition

Circulation Disorders

Coronary Artery Disease

Congestive Heart Failure

Treatment

N/A

Clinical Study ID

NCT04973397
MP-02-2022-9889
  • Ages > 45
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

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.

Study Design

Total Participants: 15000
Study Start date:
November 17, 2021
Estimated Completion Date:
August 31, 2026

Study Description

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.

Connect with a study center

  • Hamilton General Hospital

    Hamilton, Ontario
    Canada

    Active - Recruiting

  • Juravinski Hospital and Cancer Centre

    Hamilton, Ontario
    Canada

    Active - Recruiting

  • McMaster University Medical Centre

    Hamilton, Ontario
    Canada

    Active - Recruiting

  • St-Joseph's Healthcare Hamilton

    Hamilton, Ontario L8N 4A6
    Canada

    Site Not Available

  • Mount Sinai Hospital

    Toronto, Ontario M5G 1X5
    Canada

    Active - Recruiting

  • St-Micheal's Hospital

    Toronto, Ontario
    Canada

    Active - Recruiting

  • Toronto Western Hospital

    Toronto, Ontario M5T 2S8
    Canada

    Active - Recruiting

  • Centre Hospitalier de l'Université de Montréal (CHUM)

    Montreal, Quebec H2X0C1
    Canada

    Active - Recruiting

  • Centre Hospitalier Universitaire de Sherbrooke

    Sherbrooke, Quebec
    Canada

    Site Not Available

  • Maasstad Ziekenhuis Rotterdam

    Rotterdam,
    Netherlands

    Active - Recruiting

  • Hospital Clinic Barcelona

    Barcelona,
    Spain

    Active - Recruiting

  • Wake Forest Baptist Medical Centre

    Winston-Salem, North Carolina 27157
    United States

    Active - Recruiting

  • Cleveland Clinic Foundation Fairview Campus

    Cleveland, Ohio 44111
    United States

    Active - Recruiting

  • Cleveland Clinic Foundation Main Campus

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

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