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Vascular Events in Noncardiac Surgery Patients Cohort Evaluation Study 2

NCT07300579 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 20000

Last updated 2026-04-14

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • McMaster University

    collaborator OTHER

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Population Health Research Institute

    collaborator OTHER

  • Hamilton Health Sciences Corporation

    lead OTHER

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2031-06-30
Completion
2032-06-30

Countries

  • Canada

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07300579 on ClinicalTrials.gov