NCT05866874Recruiting

Monitoring of Vital Signs for Phenotyping of Perioperative Myocardial Infarction/Injury After Noncardiac Surgery

Continuous Monitoring of Vital Signs for Improved Phenotyping of Perioperative Myocardial Infarction/Injury After Noncardiac Surgery in High Risk Patients: PMI-VITAL

Source: ClinicalTrials.gov · Last updated 28 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

The goal of this observational prospective cohort study is to learn about the pathophysiology of perioperative myocardial infarction/injury in high-risk patients undergoing major non-cardiac surgery. Participants will: * Wear wearable device (Basler Band) for up to seven days after the operation or until hospital discharge * Provide three blood samples. A venous specimen of blood (25 mL) will be collected preoperatively and on postoperative days 1 and 2. * Be contacted to answer a questionnaire one year after the surgery.

Status (registry): Recruiting
Study type: Observational
Enrollment: 875 (estimated)
First submitted: 10 May 2023
Start date: 20 Sept 2022
Primary completion date: Dec 2025
Lead sponsor: University Hospital, Basel, Switzerland
Diseases: Coronary artery disease
NCT number: NCT05866874

What you commit to

Study type: Observational
Planned participants: 875
From 20 Sept 2022 to the primary completion date, Dec 2025
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Heart surgery, cardiac arrest, acute mycardial infarction (AMI), cardiac valve intervention, or cardiac catheter ablation within 14 days prior to surgery OR involvement of heart surgery at index surgery OR surgery planned on cardiopulmonary bypass
Patients undergoing plastic/reconstructive, ophthalmologic, dental, hand surgery, or ear-nose-and-throat surgery

Other illness

Chronic renal failure on dialysis, unless undergoing renal transplant surgery
Moderate to severe dementia

Other

Patient's refusal
Inclusion into study within the last year

Who the study is looking for

Patient eligible for routine PMI-screening
Patient requiring hospitalisation with ≥ 2 overnight stays after surgery
Age ≥ 40 years to ≤ 85 AND history of coronary artery disease (CAD), peripheral artery disease (PAD), cerebrovascular disease/stroke, insulin-dependent diabetes mellitus (IDDM), or chronic heart failure (CHF)
Elective surgery
Patients undergoing orthopaedic, traumatology, vascular, spinal, thoracic, neurosurgical, urological or visceral surgery
Patient consent available

Age in the registry: 40 years to 85 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
University Hospital Basel Coordinator of this site? Confirm its status	Basel	Switzerland	Recruiting

Related publications

Perioperative discontinuation of SGLT2-inhibitors and cardiac complications after noncardiac surgery: secondary analysis of two prospective observational cohort studies.Br J Anaesth · 2026 · PMID 42270529

This page is information, not medical advice. Discuss any trial with your doctor.