Vascular Events in Noncardiac Surgery Patients Cohort Evaluation Study 2 (VISION-2)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sepsis; Post-operative Complications; Myocardial Injury After Noncardiac Surgery (MINS); Bleeding Independently Associated With Mortality After Noncardiac Surgery (BIMS); Infection Without Sepsis
• Intervention / Treatment: Device: Continuous vital signs measurement device

• Study Type: Observational
• Enrollment (Estimated): 20000

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N 4A6
      • St. Joseph's Healthcare Hamilton
    • Hamilton, Ontario, Canada, L8L 2X2
      • Hamilton General Hospital
    • Hamilton, Ontario, Canada, L8V 1C3
      • Juravinski Hospital & Cancer Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

Inclusion Criteria:

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

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	Death by any cause	30 days after surgery
Vascular mortality	Any death with a vascular cause and includes those deaths following a myocardial infarction, cardiac arrest, stroke, cardiac revascularization procedure (i.e., percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG] surgery), heart failure, pulmonary embolus, cardiovascular hemorrhage (i.e., hemorrhage causing cardiac tamponade, non-traumatic vascular rupture [e.g., aortic aneurism, cerebrovascular aneurism], non-stroke intracranial hemorrhage), or deaths due to an unknown cause.	30 days and 1 year after surgery
Myocardial infarction (MI)	The definition of myocardial infarction follows the 4th universal definition	30 days and 1 year after surgery
Stroke	An acute episode of neurological dysfunction consistent with an ischemic or hemorrhagic cause. For the diagnosis of stroke, the following criteria must be fulfilled: a) rapid onset of a focal/global neurologic deficit with at least one of the following: change in level of consciousness, hemiplegia, hemiparesis, numbness or sensory loss affecting one side of the body, dysphagia/aphasia, hemianopia, amaurosis, or other new neurological signs/symptoms consistent with stroke; b) the duration of a focal/global neurologic deficit is at least 24 hours, OR the neurological deficit results in death, OR there is neuroimaging evidence of a new infarct/ hemorrhage; and c) there is no other readily identifiable non-stroke cause for the clinical presentation (e.g., brain tumor, trauma, infection, hypoglycemia, peripheral lesion).	30 says and 1 year after surgery
Proximal venous thromboembolism (VTE)	Proximal VTE includes pulmonary embolism or proximal deep vein thrombosis.	30 days and 1 year after surgery
Proximal deep venous thrombosis (DVT)	The diagnosis of proximal deep venous thrombosis requires: Thrombosis involving the popliteal vein or more proximal veins for leg DVT or axillary or more proximal veins for arm DVTs. Any of the following defines evidence of vein thrombosis: A persistent intraluminal filling defect on contrast venography (including on computed tomography), Noncompressibility of one or more venous segments on B mode compression ultrasonography, or a clearly defined intraluminal filling defect on doppler imaging in a vein that cannot have compressibility assessed (e.g., iliac, inferior vena cava, subclavian).	30 days and 1 year after surgery
Pulmonary embolism (PE)	The diagnosis requires symptoms and any one of the following: a high probability ventilation/perfusion lung scan,; an intraluminal filling defect of segmental or larger artery on a helical CT scan,; an intraluminal filling defect on pulmonary angiography, or; a positive diagnostic test for DVT (e.g., positive compression ultrasound) and one of the following: i) non-diagnostic (i.e., low or intermediate probability) ventilation/perfusion lung scan, or ii) non-diagnostic (i.e., subsegmental defects or technically inadequate study) helical CT scan	30 days and 1 year after surgery
Acute kidney injury (AKI)	Increase in serum creatinine concentration from the preoperative (pre-enrollment) concentration by either an increase of ≥26.5 μmol/L (≥0.3 mg/dL) within 48 hours of surgery or an increase of 50% or greater within 7 days of surgery.	30 days and 1 year after surgery
New acute renal failure resulting in dialysis	New acute renal failure resulting in use of a hemodialysis machine or peritoneal dialysis apparatus	30 days and 1 year after surgery
Acute heart failure	Acute Heart Failure is defined as a clinical sign (i.e., at least one of the following: elevated jugular venous pressure, respiratory rales/crackles, crepitations, or presence of S3) and at least one of the following: Radiographic findings (i.e., at least one of the following: vascular redistribution, interstitial pulmonary edema, frank alveolar pulmonary edema, or multiple and diffuse bilateral B lines on ultrasonography);; Elevated levels of natriuretic peptides; or; Heart failure treatment implemented with diuretics with documented clinical improvement.	30 days and 1 year after surgery
New clinically important atrial fibrillation	The definition of clinically important atrial fibrillation requires the documentation of atrial fibrillation of any duration on an ECG or rhythm strip, which results in angina, congestive heart failure, symptomatic hypotension, or requires treatment with a rate controlling drug, antiarrhythmic drug, or electrical cardioversion.	30 days and 1 year after surgery
Nonfatal cardiac arrest	Successful resuscitation from either documented or presumed ventricular fibrillation, sustained ventricular tachycardia, asystole, or pulseless electrical activity requiring cardiopulmonary resuscitation, pharmacological therapy, or cardiac defibrillation.	30 days and 1 year after surgery
Life-threatening bleeding	Life-threatening bleeding is bleeding that is fatal or leads to: significant hypotension that requires inotrope or vasopressor therapy, or urgent (within 24 hours) surgery (other than superficial vascular repair).	30 days and 1 year after surgery
Critical organ bleeding	A critical organ bleeding event is bleeding that was intracranial, intraocular, intraspinal, pericardial, retroperitoneal, or intramuscular with compartment syndrome.	30 days and 1 year after surgery
Amputation	Any amputation procedure, or auto amputation after the initial surgery.	30 days and 1 year after surgery
Delirium	For the diagnosis of delirium any one of the following criteria is required: Patient meets the criteria for delirium on any in-person delirium assessment based on the Confusion Assessment Method (CAM) or any of its operationalizations (e.g., 3D-CAM, CAM-ICU); OR; Positive history of delirium based on the review of hospital health records.	30 days and 1 year after surgery
Pneumonia	An acute infection of the pulmonary parenchyma that is associated with at least one sign or symptom of lower respiratory acute infection (e.g., cough, pleuritic chest pain) or acute systemic illness (e.g., fever, chills, confusion, hypoxemia); accompanied by the presence of an acute infiltrate/consolidation on a chest radiograph or auscultatory findings consistent with pneumonia (such as crackles and/or localized rales) for which there is no other explanation.	30 days and 1 year after surgery
Surgical site infection	An infection that involves the skin, subcutaneous tissue of the incision (superficial incisional), or the deep soft tissue (e.g., fascia, muscle) of the incision (deep incisional).	30 days and 1 year after surgery
Urinary tract infection	An infection that involves the urinary tract.	30 days and 1 year after surgery
Clinically important ileus	Physician diagnosis of functional obstruction of the gastrointestinal tract in the absence of an alternative diagnosis that leads to postoperative decreased bowel activity. The definition requires the following criteria: inability to pass flatus or stool for >24 hours; and; persistence of one or more of the following signs and symptoms for >24h (abdominal distention; diffuse abdominal pain; or nausea or vomiting.	30 days and 1 year after surgery
Falls	Fall from standing height or walking	30 days and 1 year after surgery
Post-discharge acute hospital care	A composite outcome of hospital re-admission and emergency department visit, which includes urgent-care centre visit.	30 days after surgery
Emergency department visit	Visit to an emergency department, which includes urgent-care centre visits.	30 days after surgery
Rehospitalization	Admission to acute care hospital after initial discharge from hospital for index surgery.	30 days after surgery
Sepsis	The Third International Consensus Definitions Task Force defines sepsis as a "life-threatening organ dysfunction due to a dysregulated host response to infection." 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: Glasgow Coma Scale (GCS) score of 13 or less (1 point),; systolic blood pressure of 100 mm Hg or less (1 point), and; respiratory rate of 22 breaths/min or more (1 point).	1 year 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.	1 year after surgery
Peripheral arterial thrombosis	The investigators will consider a peripheral arterial thrombosis to have occurred where there is clear evidence of abrupt occlusion of a peripheral artery (i.e., not a stroke, myocardial infarction, or pulmonary embolism) consistent with either an acute local thrombotic event or a peripheral arterial embolism. To fulfill this definition, the investigators require at least one of the following objective findings of peripheral arterial thrombosis: Surgical report indicating evidence of arterial thrombosis/ peripheral arterial embolism;; Pathological specimen demonstrating arterial thrombosis/ peripheral arterial embolism;; Imaging evidence consistent with arterial thrombosis/ peripheral arterial embolism; or; Autopsy reports documenting arterial thrombosis/ peripheral arterial embolism	30 days and 1 year after surgery

Collaborators and Investigators

• Sponsor: Hamilton Health Sciences Corporation
• Collaborators: Canadian Institutes of Health Research (CIHR); McMaster University; Population Health Research Institute

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2031
• Study Completion (Estimated): June 1, 2032

Study Registration Dates

• First Submitted: December 10, 2025
• First Submitted That Met QC Criteria: December 10, 2025
• First Posted (Actual): December 24, 2025

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathological Conditions, Signs and Symptoms; Sepsis
• Other Study ID Numbers: 1.0.2026.01.13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No