Implementation of a Clinical Screening and Response System for Cardiac Complications After Noncardiac Surgery
NCT ID: NCT05859620
Last Updated: 2025-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
900 participants
OBSERVATIONAL
2021-07-01
2025-12-31
Brief Summary
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Specifically, the investigators aim to: 1) evaluate the feasibility of implementation of a PMI-screening; 2) evaluate the medicoeconomic impact of implementing a PMI-screening; 3) identify barriers to implementation; 4) generate data for a future randomized controlled trial on outcomes by exploring opportunities to improve care following PMI, the occurrence and timing of major adverse cardiac events (MACE), and the treatment effect associated with PMI-screening.
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Detailed Description
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Aim: to show feasibility of implementation as well as health economic impact of an active surveillance for the early detection of PMI in high-risk patients.
Methodology: in this observational before-after study the investigators will enrol patients at high cardiovascular risk undergoing noncardiac surgery before and after implementation of a PMI screening. Patients in the pre-implementation phase will receive standard of care, while in the post-implementation phase patients receive a PMI-screening, consisting of a preoperative and two postoperative measurements of high-sensitivity cTn (hs-cTn) and a cardiology consultation will be done in case of detection of a PMI. Patient data, resource utilisation, and PMI-aetiology will be collected. Interviews with key stakeholders will identify barriers to implementation. One-year follow-up will be conducted to evaluate occurrence of death, MACE, and safety endpoints.
Potential significance: This study will generate important insights regarding the feasibility, safety and the health economic impact of implementing an active surveillance for the early detection of PMI.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Before implementation
Patients included before implementation of the PMI-screening
Patient assessment and follow-up
There is no study-specific intervention. The investigators will record data generated by clinical activity before, during and after implementation of the PMI-screening. Follow-up data and the final PMI event adjudication will be the only data generated specifically for this study.
After implementation
Patients included after implementation of the PMI-screening
Patient assessment and follow-up
There is no study-specific intervention. The investigators will record data generated by clinical activity before, during and after implementation of the PMI-screening. Follow-up data and the final PMI event adjudication will be the only data generated specifically for this study.
Interventions
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Patient assessment and follow-up
There is no study-specific intervention. The investigators will record data generated by clinical activity before, during and after implementation of the PMI-screening. Follow-up data and the final PMI event adjudication will be the only data generated specifically for this study.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
40 Years
85 Years
ALL
No
Sponsors
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Luzerner Kantonsspital
OTHER
Kantonsspital Olten
OTHER
Medical University Innsbruck
OTHER
University Hospital, Geneva
OTHER
Bürgerspital Solothurn
OTHER
University Hospital, Basel, Switzerland
OTHER
Responsible Party
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Principal Investigators
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Christian Puelacher, MD-PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Basel, Switzerland
Christian Müller, Prof.
Role: STUDY_DIRECTOR
University Hospital, Basel, Switzerland
Locations
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University Hospital Innsbruck
Innsbruck, Tyrol, Austria
University Hospital Geneva
Geneva, Canton of Geneva, Switzerland
Cantonal Hospital Lucerne
Lucerne, Canton of Lucerne, Switzerland
Canton Hospital Olten
Olten, Canton of Solothurn, Switzerland
Bürgerspital Solothurn
Solothurn, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2020-02899
Identifier Type: -
Identifier Source: org_study_id
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