Monitoring vital signs to understand heart issues after major surgery
Continuous Monitoring of Vital Signs for Improved Phenotyping of Perioperative Myocardial Infarction/Injury After Noncardiac Surgery in High Risk Patients: PMI-VITAL
University Hospital, Basel, Switzerland · NCT05866874
This study is testing how monitoring vital signs and collecting blood samples can help us understand heart problems in high-risk patients after major surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 875 (estimated) |
| Ages | 40 Years to 85 Years |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland (other) |
| Locations | 1 site (Basel, Canton of Basel-City) |
| Trial ID | NCT05866874 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the pathophysiology of perioperative myocardial infarction and injury in high-risk patients undergoing major non-cardiac surgeries. Participants will wear a wearable device to monitor vital signs for up to seven days post-surgery and provide blood samples at specified intervals. Additionally, they will complete a questionnaire one year after their surgery to gather long-term data. The study seeks to improve understanding of the various underlying causes of myocardial injury during the perioperative period.
Who should consider this trial
Good fit: Ideal candidates are patients aged 40 to 85 with a history of coronary artery disease, peripheral artery disease, cerebrovascular disease, insulin-dependent diabetes, or chronic heart failure who are undergoing elective major non-cardiac surgery.
Not a fit: Patients who have had recent heart surgery, acute myocardial infarction, or those undergoing certain types of surgeries like plastic or dental procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better identification and management of patients at risk for perioperative myocardial injury, potentially reducing mortality rates.
How similar studies have performed: While the specific approach of this study may be novel, previous research has indicated that monitoring vital signs can provide valuable insights into perioperative complications.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Basel, Canton of Basel-City
- University Hospital Basel — Basel, Canton of Basel-City, Switzerland (RECRUITING)
Study contacts
- Principal investigator: Christian Müller, MD, Prof — University Hospital, Basel, Switzerland
- Study coordinator: Christian Müller, MD, Prof
- Email: christian.mueller@usb.ch
- Phone: +41 61 328 6549
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Perioperative Myocardial Infarction, Perioperative Myocardial Injury, Perioperative myocardial injury/infraction, Myocardial ischemia/diagnosis, Myocardial ischemia/epidemiology, Perioperative complications/diagnosis, PMI