Screening for heart complications after non-heart surgery
Implementation of a Clinical Screening and Response System for the Early Detection of Cardiac Complications After Noncardiac Surgery: Feasibility and Medicoeconomic Impact
This study is testing a new screening system to see if it can help find heart problems in high-risk patients who are having non-heart surgeries.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 900 (estimated) |
| Ages | 40 Years to 85 Years |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Locations | 5 sites (Innsbruck, Tyrol and 4 other locations) |
| Trial ID | NCT05859620 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the feasibility and economic impact of a clinical screening system designed to detect cardiac complications in high-risk patients undergoing noncardiac surgery. The study will compare outcomes before and after implementing a screening protocol that includes measuring cardiac troponin levels and providing cardiology consultations when necessary. By identifying barriers to implementation and collecting data on patient outcomes, the study seeks to lay the groundwork for future randomized controlled trials focused on improving care for patients at risk of perioperative myocardial injury.
Who should consider this trial
Good fit: Ideal candidates are patients aged 40-85 years with increased cardiovascular risk undergoing inpatient, noncardiac elective or emergent surgery.
Not a fit: Patients who have undergone cardiac surgery recently, have chronic renal failure requiring dialysis, or have moderate-to-severe dementia may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier detection and better management of cardiac complications, potentially reducing mortality rates in high-risk surgical patients.
How similar studies have performed: While the approach of using active surveillance for cardiac complications is gaining recognition, this specific implementation and its economic impact have not been widely tested, making it a novel endeavor.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Consecutive patients fulfilling the institutional criteria for inclusion into the routine PMI-screening * aged 40-85 years * at increased cardiovascular risk * undergoing inpatient, noncardiac, elective or emergent surgery * postoperative stay of ≥2 nights at the participating institution * orthopaedic, traumatology, vascular, spinal, thoracic, neurosurgical, and visceral surgery. Exclusion Criteria: * patients with cardiac surgery or interventions in the last 14 days * chronic renal failure under dialysis, renal transplant surgery * moderate-to-severe dementia * previous inclusion within 5 days * documented refusal to use of their data for research purposes or refusal of further use during follow-up * Patients declining consent for follow-up will be excluded from follow-up analyses.
Where this trial is running
Innsbruck, Tyrol and 4 other locations
- University Hospital Innsbruck — Innsbruck, Tyrol, Austria (Recruiting)
- University Hospital Geneva — Geneva, Ge, Switzerland (Not_yet_recruiting)
- Cantonal Hospital Lucerne — Lucerne, Lu, Switzerland (Recruiting)
- Canton Hospital Olten — Olten, So, Switzerland (Active_not_recruiting)
- Bürgerspital Solothurn — Solothurn, Switzerland (Recruiting)
Study contacts
- Principal investigator: Christian Puelacher, MD-PhD — University Hospital, Basel, Switzerland
- Study coordinator: Christian Puelacher, MD-PhD
- Email: christian.puelacher@usb.ch
- Phone: +41 76 403 44 50
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.