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

NCT ID: NCT04973397

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 15000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-11-17
• Study Completion Date: 2026-08-31

Brief 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.

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.

Conditions

Preoperative Care; Surgery--Complications; Myocardial Infarction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Université de Montréal

OTHER

Sponsor Role: collaborator

Fonds de la Recherche en Santé du Québec

OTHER_GOV

Sponsor Role: collaborator

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emmanuelle Duceppe, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier de l'Universite de Montreal (CHUM)

Locations

Wake Forest Baptist Medical Centre

Winston-Salem, North Carolina, United States

Site Status: RECRUITING

Cleveland Clinic Foundation Fairview Campus

Cleveland, Ohio, United States

Site Status: RECRUITING

Cleveland Clinic Foundation Main Campus

Cleveland, Ohio, United States

Site Status: RECRUITING

MD Anderson Cancer Center

Houston, Texas, United States

Site Status: RECRUITING

Memorial Hermann Texas Medical Center UT Health

Houston, Texas, United States

Site Status: RECRUITING

St-Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Site Status: ACTIVE_NOT_RECRUITING

Hamilton General Hospital

Hamilton, Ontario, Canada

Site Status: RECRUITING

Juravinski Hospital and Cancer Centre

Hamilton, Ontario, Canada

Site Status: RECRUITING

McMaster University Medical Centre

Hamilton, Ontario, Canada

Site Status: RECRUITING

Mount Sinai Hospital

Toronto, Ontario, Canada

Site Status: RECRUITING

Toronto Western Hospital

Toronto, Ontario, Canada

Site Status: RECRUITING

St-Micheal's Hospital

Toronto, Ontario, Canada

Site Status: RECRUITING

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, Canada

Site Status: RECRUITING

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Site Status: ACTIVE_NOT_RECRUITING

Maasstad Ziekenhuis Rotterdam

Rotterdam, , Netherlands

Site Status: RECRUITING

Hospital Clinic Barcelona

Barcelona, , Spain

Site Status: RECRUITING

Countries

United States; Canada; Netherlands; Spain

Central Contacts

Melodie Fanay Boko, MSc

Role: CONTACT

melodie.fanay.boko.chum@ssss.gouv.qc.ca

514-890-8000 ext. 31541

Facility Contacts

Ashish K Khanna, MD, MSc

Role: primary

Sabry Ayad, MD, MBA

Role: primary

Daniel Sessler, MD

Role: primary

Juan P Cata, MD

Role: primary

Mehmet Alparslan Turan, MD

Role: primary

John Harlock, MD, MSc

Role: primary

Ameen Patel, MD

Role: primary

Jessica Spence, MD, PhD

Role: primary

James Khan, MD

Role: primary

Mandeep Singh, MBBS, MD, MSc, FRCPC

Role: primary

Duminda M Wijeysundera, MD, PhD

Role: primary

Melodie Fanay Boko, BSc

Role: primary

melodie.fanay.boko.chum@ssss.gouv.qc.ca

514-890-8000 ext. 31541

Joseph Koopman, MD, PhD

Role: primary

Eva Rivas, MD, PhD

Role: primary

References

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.

Reference Type: RESULT

PMID: 38669010 (View on PubMed)

Other Identifiers

MP-02-2022-9889

Identifier Type: -

Identifier Source: org_study_id