Actively Recruiting
Continuous Monitoring of Vital Signs for Improved Phenotyping of Perioperative Myocardial Infarction/Injury After Noncardiac Surgery in High Risk Patients: PMI-VITAL
Led by University Hospital, Basel, Switzerland · Updated on 2025-01-28
875
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to better understand perioperative myocardial infarction/injury (PMI) in high-risk patients undergoing major non-cardiac surgery. PMI is a significant contributor to deaths following surgery and includes various underlying causes such as heart attacks, oxygen supply issues, arrhythmias, heart failure, and conditions outside the heart like sepsis or stroke. The study focuses on uncovering the triggers of PMI by using continuous vital sign monitoring and blood tests, as the exact causes remain unclear in many cases. Participants will wear a multi-sensor wearable device called the Basler Band to continuously monitor vital signs such as heart rate, heart rhythm, respiration, and activity for up to seven days after surgery or until hospital discharge. Blood samples will be taken before surgery and on the first two days after surgery to analyze biomarkers. The study also validates the wearable device's accuracy by comparing its measurements to routine clinical data. One year after surgery, participants will answer a questionnaire to provide additional information. During the study, participants will have blood drawn three times and wear the Basler Band to record continuous vital signs. Researchers will track heart rhythm abnormalities, blood pressure changes, oxygen levels, and other key measures during and after surgery. They will also assess major adverse cardiac and cerebrovascular events up to one year later. The overall participation lasts about one week, plus the follow-up questionnaire after one year. Biological samples collected will be stored for future research under strict privacy protections.
CONDITIONS
Brief Title
Monitoring of Vital Signs for Phenotyping of Perioperative Myocardial Infarction/Injury After Noncardiac Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient eligible for routine PMI-screening
- Patient requiring hospitalisation with 65 2 overnight stays after surgery
- Age 65 40 years to 64 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From surgery day up to 7 days after surgery or until hospital discharge
Participants will wear a multi-sensor wearable device to continuously monitor vital signs such as heart rate, heart rhythm, respiration rate, and activity during and after surgery to help identify perioperative myocardial infarction/injury.
Continuous monitoring with wearable device during hospital stay
Duration - 3 days around surgery
Venous blood samples are collected before surgery and on postoperative days 1 and 2 to evaluate biochemical markers and validate diagnoses related to myocardial injury.
3 blood draws coordinated with routine clinical blood draws
Duration - 1 year after surgery
Participants will answer a follow-up questionnaire approximately one year after surgery to assess major adverse cardiac and cerebral events and other outcomes.
1 follow-up questionnaire
Trial Site Locations
Total: 1 location
1
University Hospital Basel
Basel, Canton of Basel-City, Switzerland, 4031
Actively Recruiting
Research Team
C
Christian Müller, MD, Prof
C
Christian Puelacher, MD-PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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