NCT07300579

Vascular Events in Noncardiac Surgery Patients Cohort Evaluation Study 2

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 20,000 (estimated)
• Sponsor: Hamilton Health Sciences Corporation · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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, the investigators 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

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2026-06-01
• Primary completion: 2031-06-01
• Completion: 2032-06-01
• First posted: 2025-12-24
• Last updated: 2026-04-14

Locations

3 sites across 1 country: Canada