Vascular Events in Noncardiac Surgery Patients Cohort Evaluation Study 2

NCT07300579 | Not Yet Recruiting

• 1 other identifier: 1.0.2026.01.13
• Study Type: observational
• Target: 20,000
• Locations: 1 country
• Sites: 3

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, 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

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

Outcome Measures

Primary Outcomes (4)

• Myocardial injury after noncardiac surgery (MINS)

  MINS not meeting 4th definition of MI is an elevated troponin measurement that occurs during the first 30 days after surgery that is judged as resulting from myocardial ischemia AND does not fulfill the MI definition. The following defines elevated troponin measurement for the diagnosis of MINS during the first 30 days after surgery: non high sensitivity Troponin T assay: ≥0.03 µg/L; high sensitivity Troponin T assay: between 20 - \<65 ng/L with an absolute change ≥5 ng/L or a value ≥65 ng/L; DVIA Centaur Siemens high-sensitivity cardiac troponin I: ≥75 ng/L; ARCHITECT STAT Abbott Laboratories high-sensitivity cardiac troponin I ≥60 ng/L; other troponin assays: any measurement above the 99th percentile of the upper reference limit.

  30 days after surgery

• Bleeding independently associated with mortality after noncardiac surgery (BIMS)

  A bleeding meeting any of the following 3 criteria: a) leading to a postoperative hemoglobin \<70 g/L; b) requiring transfusion of one or more units of red blood cells; c) judged to be the immediate cause of death

  30 days after surgery

• Sepsis

  Based on the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) criteria, sepsis will require a quick Sequential Organ Failure Assessment (qSOFA) Score ≥2 points due to infection. The qSOFA includes the following items and scoring system: a) Glasgow Coma Scale (GCS) score of 13 or less (1 point); b) systolic blood pressure of 100 mm Hg or less (1 point); and c) respiratory rate of 22 breaths/min or more (1 point).

  30 days after surgery

• Infection without sepsis

  Pathologic process caused by the invasion of normally sterile tissue or fluid or body cavity by pathogenic or potentially pathogenic organisms.

  30 days after surgery

Secondary Outcomes (27)

• All-cause mortality

  30 days after surgery

• Vascular mortality

  30 days and 1 year after surgery

• Myocardial infarction (MI)

  30 days and 1 year after surgery

• Stroke

  30 says and 1 year after surgery

• Proximal venous thromboembolism (VTE)

  30 days and 1 year after surgery

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.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients 65 years of age and older undergoing non-cardiac surgery with anesthesia expected to require an expected length of hospital stay of 3 or more days

You may qualify if:

• age ≥65 years;
• underwent non-cardiac surgery with general, neuraxial, local, or regional anesthesia; and
• expected length of hospital stay of 3 or more days

You may not qualify if:

• hearing aid(s) or cochlear implant(s) in left ear;
• pacemaker/implantable cardioverter-defibrillator (ICD);
• externally programmable cerebrospinal fluid shunt;
• deep brain stimulator;
• intolerance/allergy to adhesive;
• history of dementia, or;
• previous enrollment in the VISION-2 Study

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• McMaster University: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator
• Population Health Research Institute: collaborator

Study Sites (3)

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

Juravinski Hospital & Cancer Centre

Hamilton, Ontario, L8V 1C3, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood and plasma

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: December 24, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2031
• Study Completion (Estimated): June 1, 2032
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)