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

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: Recruiting
• Conditions: Myocardial Infarction; Surgery--Complications; Preoperative Care

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: Observational
• Enrollment (Estimated): 15000

Contacts and Locations

• Study Contact: Name: Melodie Fanay Boko, MSc; Phone Number: 31541 514-890-8000; Email: melodie.fanay.boko.chum@ssss.gouv.qc.ca

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'Universite de Montreal (CHUM)
      • Contact: Melodie Fanay Boko, BSc; Phone Number: 31541 514-890-8000; Email: melodie.fanay.boko.chum@ssss.gouv.qc.ca
      • 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

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unplanned healthcare utilization	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

Outcome Measure	Measure Description	Time Frame
unplanned admission	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	the number of patient who had a medical visit in an outpatient setting after undergoing same-day surgery	90 days
emergency room visit	the number of patients who visited the emergency room without subsequent hospitalization after undergoing same-day surgery	90 days
re-hospitalization	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	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)	the number of patients who experience a MINS	90 days
myocardial infarction	the number of patients who experience a myocardial infarction	90 days
non-fatal cardiac arrest	the number of patients who experience a non-fatal cardiac arrest	90 days
coronary revascularization	the number of patients who undergo coronary revascularization	90 days
stroke	the number of patients who experience a stroke	90 days
transient ischemic attack	the number of patients who experience a transient ischemic attack	90 days
new clinically important arrythmia	the number of patients who experience a new clinically important arrythmia	90 days
acute congestive heart failure	the number of patients who experience an acute congestive heart failure episode	90 days
deep vein thrombosis	the number of patients who experience a deep vein thrombosis	90 days
pulmonary embolism	the number of patients who experience a pulmonary embolism	90 days
major postoperative and life-threatening bleeding	the number of patients who experience a major postoperative and/or life-threatening bleeding	90 days
postoperative infection	the number of patients who experience a postoperative infection	90 days
acute kidney injury	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	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)	change in the score on the Duke Activity Status Index (DASI) questionnaire (0 to 58.2 points)	90 days
frailty	change in the level on the Clinical Frailty Scale (level 1 to 9)	90 days

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Collaborators: Canadian Institutes of Health Research (CIHR); Université de Montréal; Fonds de la Recherche en Santé du Québec
• Investigators: Principal Investigator: Emmanuelle Duceppe, MD, PhD, Centre Hospitalier de l'Universite de Montreal (CHUM)

Publications and helpful links

General Publications

• Boko MF, Khanna AK, D'Aragon F, Spence J, Conen D, Patel A, Ayad S, Wijeysundera DN, Choiniere M, Sessler DI, Carrier FM, Harlock J, Koopman JSHA, Durand M, Bhojani N, Turan A, Page G, Devereaux PJ, Duceppe E; VALIANCE Study Collaborators. Incidence and Risk Factors of Chronic Postoperative Pain in Same-day Surgery: A Prospective Cohort Study. Anesthesiology. 2024 Aug 1;141(2):286-299. doi: 10.1097/ALN.0000000000005030.

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: July 13, 2021
• First Submitted That Met QC Criteria: July 13, 2021
• First Posted (Actual): July 22, 2021

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Surgery; Postoperative complications; Ambulatory surgery; Outpatient surgery; Preoperative Care; Same-day surgery
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Myocardial Ischemia; Ischemia; Pathological Conditions, Signs and Symptoms; Myocardial Infarction; Postoperative Complications
• Other Study ID 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