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

March 17, 2026 updated by: Centre hospitalier de l'Université de Montréal (CHUM)

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada
        • Recruiting
        • Hamilton General Hospital
        • Contact:
          • John Harlock, MD, MSc
      • Hamilton, Ontario, Canada
        • Recruiting
        • Juravinski Hospital and Cancer Centre
        • Contact:
          • Ameen Patel, MD
      • Hamilton, Ontario, Canada
        • Recruiting
        • McMaster University Medical Centre
        • Contact:
          • Jessica Spence, MD, PhD
      • Hamilton, Ontario, Canada, L8N 4A6
        • Active, not recruiting
        • St-Joseph's Healthcare Hamilton
      • Toronto, Ontario, Canada, M5G 1X5
        • Recruiting
        • Mount Sinai Hospital
        • Contact:
          • James Khan, MD
      • Toronto, Ontario, Canada, M5T 2S8
        • Recruiting
        • Toronto Western Hospital
        • Contact:
          • Mandeep Singh, MBBS, MD, MSc, FRCPC
      • Toronto, Ontario, Canada
        • Recruiting
        • St-Micheal's Hospital
        • Contact:
          • Duminda M Wijeysundera, MD, PhD
    • Quebec
      • Montreal, Quebec, Canada, H2X0C1
        • Recruiting
        • Centre hospitalier de l'Université de Montréal (CHUM)
        • Contact:
        • Principal Investigator:
          • Emmanuelle Duceppe, MD, PhD
      • Sherbrooke, Quebec, Canada
        • Active, not recruiting
        • Centre Hospitalier Universitaire de Sherbrooke
  • Netherlands
      • Rotterdam, Netherlands
        • Recruiting
        • Maasstad Ziekenhuis Rotterdam
        • Contact:
          • Joseph Koopman, MD, PhD
  • Spain
      • Barcelona, Spain
        • Recruiting
        • Hospital Clinic Barcelona
        • Contact:
          • Eva Rivas, MD, PhD
  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest Baptist Medical Centre
        • Contact:
          • Ashish K Khanna, MD, MSc
    • Ohio
      • Cleveland, Ohio, United States, 44111
        • Recruiting
        • Cleveland Clinic Foundation Fairview Campus
        • Contact:
          • Sabry Ayad, MD, MBA
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic Foundation Main Campus
        • Contact:
          • Daniel Sessler, MD
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson Cancer Center
        • Contact:
          • Juan P Cata, MD
      • Houston, Texas, United States, 77030
        • Recruiting
        • Memorial Hermann Texas Medical Center UT Health
        • Contact:
          • Mehmet Alparslan Turan, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All eligible adults undergoing elective same-day noncardiac surgery

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
90 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
90 days
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
90 days
emergency room visit
Time Frame: 90 days
the number of patients who visited the emergency room without subsequent hospitalization after undergoing same-day surgery
90 days
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
90 days
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
90 days
myocardial injury after noncardiac surgery (MINS)
Time Frame: 90 days
the number of patients who experience a MINS
90 days
myocardial infarction
Time Frame: 90 days
the number of patients who experience a myocardial infarction
90 days
non-fatal cardiac arrest
Time Frame: 90 days
the number of patients who experience a non-fatal cardiac arrest
90 days
coronary revascularization
Time Frame: 90 days
the number of patients who undergo coronary revascularization
90 days
stroke
Time Frame: 90 days
the number of patients who experience a stroke
90 days
transient ischemic attack
Time Frame: 90 days
the number of patients who experience a transient ischemic attack
90 days
new clinically important arrythmia
Time Frame: 90 days
the number of patients who experience a new clinically important arrythmia
90 days
acute congestive heart failure
Time Frame: 90 days
the number of patients who experience an acute congestive heart failure episode
90 days
deep vein thrombosis
Time Frame: 90 days
the number of patients who experience a deep vein thrombosis
90 days
pulmonary embolism
Time Frame: 90 days
the number of patients who experience a pulmonary embolism
90 days
major postoperative and life-threatening bleeding
Time Frame: 90 days
the number of patients who experience a major postoperative and/or life-threatening bleeding
90 days
postoperative infection
Time Frame: 90 days
the number of patients who experience a postoperative infection
90 days
acute kidney injury
Time Frame: 90 days
the number of patients who experience a acute kidney injury
90 days
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)
90 days
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)
90 days
frailty
Time Frame: 90 days
change in the level on the Clinical Frailty Scale (level 1 to 9)
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre hospitalier de l'Université de Montréal (CHUM)

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Canadian Institutes of Health Research (CIHR)
Université de Montréal
Fonds de la Recherche en Santé du Québec

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Emmanuelle Duceppe, MD, PhD, Centre hospitalier de l'Université de Montréal (CHUM)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 17, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 13, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 22, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MP-02-2022-9889

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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