Clinical trial NCT05859620: Implementation of a Clinical Screening and Response System for Cardiac Complications After Noncardiac Surgery
Official title: Implementation of a Clinical Screening and Response System for the Early Detection of Cardiac Complications After Noncardiac Surgery: Feasibility and Medicoeconomic Impact
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myocardial Injury
Myocardial Infarction
Perioperative Complication
Keywords: Myocardial injury
Myocardial infarction
Perioperative care
Noncardiac surgery
Screening
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Luzerner Kantonsspital
name: Kantonsspital Olten
name: Medical University Innsbruck
name: University Hospital, Geneva
name: Bürgerspital Solothurn
First posted: 2023-05-16
Enrollment: 900
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 40-85 years at increased cardiovascular risk undergoing inpatient, noncardiac, elective or emergent surgery with a planned postoperative stay of ≥2 nights

Brief summary: The investigators aim to show the feasibility and medicoeconomic impact of implementing a clinical screening and response system for the early detection of perioperative cardiac complications in high-risk patients.

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.

Detailed description: Background: Perioperative myocardial infarction/injury (PMI) is increasingly recognised as frequent, but often undiagnosed and untreated contributor to mortality following noncardiac surgery. Due to differences in pathophysiology and perioperative anaesthesia and analgesia, most PMI do not cause typical ischemic symptoms and are therefore missed in routine clinical practice. Active surveillance using cardiac troponin (cTn) is now guideline-recommended for the early detection of PMI to possibly improve outcome1. Given substantial concerns regarding the feasibility and health economic impact of implementing such a strategy, it is not yet widely applied.

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.

Eligibility 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.

Primary outcomes:
measure: Perioperative Myocardial Infarction/Injury (PMI)-Screening (Reach)
timeFrame: during the hospital stay (up to postoperative day 2)
measure: Incidence of PMI
timeFrame: after the surgery until postoperative day 2
measure: Cardiology consultation (Fidelity)
timeFrame: during hospital stay (up to postoperative day 5)
measure: Diagnostic challenge
timeFrame: during hospital stay (up to postoperative day 5)
measure: Barriers to implementation
timeFrame: following the post-implementation period (6 months after implementation)
Secondary outcomes:
measure: Medicoeconomic impact
timeFrame: Within 3 - 30 days following surgery
measure: Resource Usage
timeFrame: Within 3 - 30 days following surgery
measure: Major adverse cardiac events (MACE)
timeFrame: 1 year
measure: Complications of cardiology diagnostics
timeFrame: 30 days
measure: Major bleeding
timeFrame: Postoperative day 1 - 1 year (blinding of first 24h following surgery)
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: University Hospital Innsbruck
state: Tyrol
city: Geneva
country: Switzerland
facility: University Hospital Geneva
state: GE
city: Lucerne
country: Switzerland
facility: Cantonal Hospital Lucerne
state: LU
city: Olten
country: Switzerland
facility: Canton Hospital Olten
state: SO
city: Solothurn
country: Switzerland
facility: Bürgerspital Solothurn
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Christian Puelacher, MD-PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Basel, Switzerland
name: Christian Müller, Prof.
role: STUDY_DIRECTOR
References: