Vascular Events in Noncardiac Surgery Patients Cohort Evaluation Study 2

Sponsor
Hamilton Health Sciences Corporation
Study ID
NCT07300579
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Continuous vital signs measurement device — 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.

Study Details

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.

Key Dates

First listed
Dec 24, 2025
Start date
Jun 30, 2026
Status verified
Apr 2026
Primary completion
Jun 30, 2031
Completion
Jun 30, 2032

Study Design

Enrollment
20,000 participants (estimated)

Primary Outcome Measure

Myocardial injury after noncardiac surgery (MINS) [ Time Frame: 30 days after surgery ]

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