RecruitingNot Applicable

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

Switzerland875 participantsStarted 2022-09-20

Plain-language summary

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.

Who can participate

Age range40 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * Patient's refusal * 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 * Chronic renal failure on dialysis, unless undergoing renal transplant surgery * Moderate to severe dementia * Inclusion into study within the last year

What they're measuring

Perioperative myocardial infarction/injury (PMI)

Timeframe: 3 days after surgery

Major adverse cardiac and cerebral events (MACCE)

Timeframe: 1 year

Postoperative atrial fibrillation (POAF)

Timeframe: During surgery and up to 7 days after surgery or until hospital discharge.

Documentation and quantification of the frequency and duration of tachyarrhythmia, bradycardia, hypotension, hypertension, and/or hypoxaemia.

Timeframe: During surgery and up to 7 days after surgery or until discharge.

Comparison of the incidence and prognostic impact of PMI detected by using different troponin assays

Timeframe: 3 days after surgery

Using biomarkers as tools for prediction of major cardiac complications in patients undergoing non-cardiac surgery

Timeframe: 3 days after surgery

Trial details

NCT IDNCT05866874

SponsorUniversity Hospital, Basel, Switzerland

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-12

Contact for this trial

Christian Müller, MD, Prof

+41 61 328 6549 christian.mueller@usb.ch

View on ClinicalTrials.gov More Perioperative Myocardial Infarction trials

Plain-language summary

Who can participate

Age range40 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Perioperative myocardial infarction/injury (PMI)

Timeframe: 3 days after surgery

Major adverse cardiac and cerebral events (MACCE)

Timeframe: 1 year

Postoperative atrial fibrillation (POAF)

Timeframe: During surgery and up to 7 days after surgery or until hospital discharge.

Documentation and quantification of the frequency and duration of tachyarrhythmia, bradycardia, hypotension, hypertension, and/or hypoxaemia.

Timeframe: During surgery and up to 7 days after surgery or until discharge.

Comparison of the incidence and prognostic impact of PMI detected by using different troponin assays

Timeframe: 3 days after surgery

Using biomarkers as tools for prediction of major cardiac complications in patients undergoing non-cardiac surgery

Timeframe: 3 days after surgery