Vascular Events In Patients Undergoing Same-day Noncardiac Surgery (VALIANCE) Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Preoperative Care, Surgery--Complications, Myocardial Infarction. Basic parameters: from 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada, Netherlands, Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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.
Primary outcome measures
- Unplanned healthcare utilization [Time frame: 90 days]
Secondary outcome measures (12)
- unplanned admission [Time frame: 90 days]
- unplanned outpatient visit [Time frame: 90 days]
- emergency room visit [Time frame: 90 days]
- re-hospitalization [Time frame: 90 days]
- major cardiovascular complications [Time frame: 90 days]
- myocardial injury after noncardiac surgery (MINS) [Time frame: 90 days]
- myocardial infarction [Time frame: 90 days]
- non-fatal cardiac arrest [Time frame: 90 days]
- coronary revascularization [Time frame: 90 days]
- stroke [Time frame: 90 days]
- transient ischemic attack [Time frame: 90 days]
- new clinically important arrythmia [Time frame: 90 days]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Canada · 9 centers
- St-Joseph's Healthcare Hamilton — Hamilton
- Hamilton General Hospital — Hamilton
- Juravinski Hospital and Cancer Centre — Hamilton
- McMaster University Medical Centre — Hamilton
- Mount Sinai Hospital — Toronto
- Toronto Western Hospital — Toronto
- St-Micheal's Hospital — Toronto
- Centre Hospitalier de l'Université de Montréal (CHUM) — Montreal
- … and 1 more center
United States · 5 centers
- Wake Forest Baptist Medical Centre — Winston-Salem
- Cleveland Clinic Foundation Fairview Campus — Cleveland
- Cleveland Clinic Foundation Main Campus — Cleveland
- MD Anderson Cancer Center — Houston
- Memorial Hermann Texas Medical Center UT Health — Houston
Netherlands · 1 center
- Maasstad Ziekenhuis Rotterdam — Rotterdam
Spain · 1 center
- Hospital Clinic Barcelona — Barcelona
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: 10.109 PMID 38669010
Identifiers
NCT: NCT04973397 · MP-02-2022-9889