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

Myocardial Infarction Clinical Trial

— VALIANCE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04973397
• Other study ID #: MP-02-2022-9889
• Status: Recruiting
• Start date: November 17, 2021
• Est. completion date: August 2026

Study information

• Verified date: December 2023
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: Melodie Fanay Boko, BSc
• Phone: 514-890-8000
• Email: melodie.fanay.boko.chum[@]ssss.gouv.qc.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15000
• Est. completion date: August 2026
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Preoperative Care
• Surgery--Complications

Locations

Country	Name	City	State
Canada	Hamilton General Hospital	Hamilton	Ontario
Canada	Juravinski Hospital and Cancer Centre	Hamilton	Ontario
Canada	McMaster University Medical Centre	Hamilton	Ontario
Canada	St-Joseph's Healthcare Hamilton	Hamilton	Ontario
Canada	Centre Hospitalier de l'Université de Montréal (CHUM)	Montreal	Quebec
Canada	Centre Hospitalier Universitaire de Sherbrooke	Sherbrooke	Quebec
Canada	St-Micheal's Hospital	Toronto	Ontario
Netherlands	Maasstad Ziekenhuis Rotterdam	Rotterdam
United States	Cleveland Clinic Foundation Fairview Campus	Cleveland	Ohio
United States	Cleveland Clinic Foundation Main Campus	Cleveland	Ohio
United States	Wake Forest Baptist Medical Centre	Winston-Salem	North Carolina

Sponsors (4)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)	Canadian Institutes of Health Research (CIHR), Fonds de la Recherche en Santé du Québec, Université de Montréal

Countries where clinical trial is conducted

United States,  Canada,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	unplanned admission	the number of patients who have to be admitted to the hospital after undergoing a surgery planned as same-day	90 days
Secondary	unplanned outpatient visit	the number of patient who had a medical visit in an outpatient setting after undergoing same-day surgery	90 days
Secondary	emergency room visit	the number of patients who visited the emergency room without subsequent hospitalization after undergoing same-day surgery	90 days
Secondary	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
Secondary	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
Secondary	myocardial injury after noncardiac surgery (MINS)	the number of patients who experience a MINS	90 days
Secondary	myocardial infarction	the number of patients who experience a myocardial infarction	90 days
Secondary	non-fatal cardiac arrest	the number of patients who experience a non-fatal cardiac arrest	90 days
Secondary	coronary revascularization	the number of patients who undergo coronary revascularization	90 days
Secondary	stroke	the number of patients who experience a stroke	90 days
Secondary	transient ischemic attack	the number of patients who experience a transient ischemic attack	90 days
Secondary	new clinically important arrythmia	the number of patients who experience a new clinically important arrythmia	90 days
Secondary	acute congestive heart failure	the number of patients who experience an acute congestive heart failure episode	90 days
Secondary	deep vein thrombosis	the number of patients who experience a deep vein thrombosis	90 days
Secondary	pulmonary embolism	the number of patients who experience a pulmonary embolism	90 days
Secondary	major postoperative and life-threatening bleeding	the number of patients who experience a major postoperative and/or life-threatening bleeding	90 days
Secondary	postoperative infection	the number of patients who experience a postoperative infection	90 days
Secondary	acute kidney injury	the number of patients who experience a acute kidney injury	90 days
Secondary	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
Secondary	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
Secondary	frailty	change in the level on the Clinical Frailty Scale (level 1 to 9)	90 days