Actively Recruiting
Continuous Monitoring of Vital Signs to Understand Heart Injury and Heart Attacks After Major Non-Heart Surgery in High-Risk Patients
Led by University Hospital, Basel, Switzerland · Updated on 2025-01-28
875
Participants Needed
1
Research Sites
219 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the causes and characteristics of perioperative myocardial infarction/injury (PMI) in high-risk patients undergoing major non-cardiac surgery. PMI is a significant contributor to deaths within 30 days after surgery and can result from different underlying conditions such as heart attacks, oxygen supply issues, irregular heart rhythms, heart failure, or other severe complications like sepsis or stroke. The study aims to better understand these causes by closely monitoring patients' vital signs and using various blood markers. Participants will wear a wearable device called the Basler Band that continuously records heart rate, heart rhythm, breathing rate, and activity for up to seven days after surgery or until hospital discharge. Blood samples will be collected before surgery and on the first two days after surgery to analyze biomarkers. The study also compares different troponin tests to confirm PMI diagnoses and evaluates the wearable device's accuracy for measuring vital signs during surgery. During the study, participants will have their vital signs monitored continuously, and researchers will collect blood samples to measure heart-related complications. One year after surgery, participants will be contacted to complete a questionnaire about their health. The main outcomes include detecting heart injury shortly after surgery, tracking heart rhythm problems, blood pressure changes, and oxygen levels, and assessing how these relate to longer-term heart and brain events. The total participation period for each patient is about one week plus the follow-up questionnaire after one year.
CONDITIONS
Official 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...
- Eligible for routine PMI screening
- Hospitalization with at least 2 overnight stays after surgery
- Age between 40 and 85 years with a history of coronary artery disease, peripheral artery disease, stroke, insulin-dependent diabetes, or chronic heart failure
- Scheduled for elective surgery
- Undergoing orthopaedic, traumatology, vascular, spinal, thoracic, neurosurgical, urological, or visceral surgery
- Provided informed consent
You will not qualify if you...
- Refusal to participate
- Heart surgery, cardiac arrest, heart attack, valve intervention, or cardiac catheter ablation within 14 days before surgery, or planned heart surgery at index surgery, or surgery with cardiopulmonary bypass
- Undergoing plastic/reconstructive, ophthalmologic, dental, hand, or ear-nose-and-throat surgery
- Chronic kidney failure on dialysis unless receiving kidney transplant surgery
- Moderate to severe dementia
- Participation in this study within the last year
AI-Screening
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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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