Vascular Events in Noncardiac Surgery Patients Cohort Evaluation Study 2

NCT ID: NCT07300579

Last Updated: 2025-12-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 20000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2031-01-31

Brief Summary

VISION-2 is an international, multi-site, prospective observational cohort study of 20,000 patients undergoing noncardiac surgery. Continuous biometric data will be blindly collected for the first 30 postoperative days, in hospital and at home, using Vitaliti™. Following study enrollment and baseline data collection, follow up visits will occur in-hospital, at 30-days, and 1-year post-operatively.

VISION-2 has 3 primary objectives, among participants who underwent noncardiac surgery, we will: 1) determine the pattern and frequency of physiological precursors (i.e., biophysical signals) to MINS, BIMS, sepsis, and infection without sepsis; 2) build prediction models from these biophysical signals and their extracted features through supervised machine learning, for the prediction and early detection of those complications; and 3) build a biobank for evaluation of novel biomarkers.

Conditions

Myocardial Injury After Noncardiac Surgery (MINS); Bleeding Independently Associated With Mortality After Noncardiac Surgery (BIMS); Sepsis; Infection Without Sepsis; Post-operative Complications

Study Design

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

Interventions

Continuous vital signs measurement device

In this observational study, enrolled participants will wear the Vitaliti™ CVSM-1A device continuously before surgery, wherever and whenever possible, or as soon as possible after surgery and for up to 30-days after surgery. We will collect continuous biometric data using the Vitaliti™ CVSM-1A device. Patients, healthcare providers, data collectors, and outcome adjudicators will be blind to the Vitaliti™ data. Data from participants will be analyzed to determine the pattern and frequency of physiological precursors to outcome events. This data will be used to inform machine learning algorithms for prediction and early detection of post-surgical complications. A biobank will also be established to support exploratory proteomic and genotyping analyses to better understand biological mechanisms underlying post-operative complications.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. age ≥65 years;

2. underwent non-cardiac surgery with general, neuraxial, local, or regional anesthesia; and

3. expected to require an overnight hospital admission after surgery.

Exclusion Criteria

1. hearing aid(s) or cochlear implant(s) in left ear;

2. pacemaker/implantable cardioverter-defibrillator (ICD);

3. externally programmable cerebrospinal fluid shunt;

4. deep brain stimulator;

5. intolerance/allergy to adhesive;

6. history of dementia, or;

7. previous enrollment in the VISION-2 Study

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McMaster University

OTHER

Sponsor Role: collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Population Health Research Institute

OTHER

Sponsor Role: collaborator

Hamilton Health Sciences Corporation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hamilton General Hospital

Hamilton, Ontario, Canada

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Juravinski Hospital & Cancer Centre

Hamilton, Ontario, Canada

Countries

Canada

Other Identifiers

1.0.2025.08.25

Identifier Type: -

Identifier Source: org_study_id