Implementation of a Clinical Screening and Response System for Cardiac Complications After Noncardiac Surgery

NCT05859620 | Active Not Recruiting DMC

• 1 other identifier: 2020-02899
• Study Type: observational
• Target: 900
• Locations: 2 countries
• Sites: 5

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.

Conditions

Myocardial Injury; Myocardial Infarction; Perioperative Complication

Keywords

Myocardial injury; Myocardial infarction; Perioperative care; Noncardiac surgery; Screening

Outcome Measures

Primary Outcomes (5)

• Perioperative Myocardial Infarction/Injury (PMI)-Screening (Reach)

  Percentage of patients eligible for PMI-screening according to inclusion criteria, but not screened during the implementation phase (defined as no or only one measurement of hs-cTn done during screening days)

  during the hospital stay (up to postoperative day 2)

• Incidence of PMI

  Percentage of patients experiencing PMI following noncardiac surgery

  after the surgery until postoperative day 2

• Cardiology consultation (Fidelity)

  Percentage of patients with detected PMI by PMI-screening on screening days, seen vs. not seen by a cardiologist

  during hospital stay (up to postoperative day 5)

• Diagnostic challenge

  Number of cases with mismatch of initial classification of PMI aetiology (and management pathway) at time of consultation versus final adjudication. In case of two differential diagnoses stated on the cardiology consultation, mismatch is seen when none of the diagnoses correspond to the final adjudication. If three or more differential diagnoses are stated, mismatch is seen in any case even if the final adjudication diagnosis is stated

  during hospital stay (up to postoperative day 5)

• Barriers to implementation

  Barriers to implementation will be assessed by a semi-quantitive questionnaire complemented by qualitative focus group including the local investigators and representatives of cardiology and anaesthesiology

  following the post-implementation period (6 months after implementation)

Secondary Outcomes (5)

• Medicoeconomic impact

  Within 3 - 30 days following surgery

• Resource Usage

  Within 3 - 30 days following surgery

• Major adverse cardiac events (MACE)

  1 year

• Complications of cardiology diagnostics

  30 days

• Major bleeding

  Postoperative day 1 - 1 year (blinding of first 24h following surgery)

Study Arms (2)

Before implementation

Patients included before implementation of the PMI-screening

Other: Patient assessment and follow-up

After implementation

Patients included after implementation of the PMI-screening

Other: Patient assessment and follow-up

Interventions

Patient assessment and follow-up OTHER

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; Before implementation

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• patients with cardiac surgery or interventions in the last 14 days
• chronic renal failure under dialysis, renal transplant surgery
• moderate-to-severe dementia
• 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.

Sponsors & Collaborators

• University Hospital, Geneva: collaborator
• Bürgerspital Solothurn: collaborator
• University Hospital, Basel, Switzerland: lead
• Luzerner Kantonsspital: collaborator
• Kantonsspital Olten: collaborator
• Medical University Innsbruck: collaborator

Study Sites (5)

University Hospital Innsbruck

Innsbruck, Tyrol, 6020, Austria

Location

University Hospital Geneva

Geneva, Canton of Geneva, 1205, Switzerland

Location

Cantonal Hospital Lucerne

Lucerne, Canton of Lucerne, 6000, Switzerland

Location

Canton Hospital Olten

Olten, Canton of Solothurn, 4600, Switzerland

Location

Bürgerspital Solothurn

Solothurn, 4500, Switzerland

Location

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Christian Puelacher, MD-PhD

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

• Christian Müller, Prof.

  University Hospital, Basel, Switzerland

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: May 16, 2023
• Study Start: July 1, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-05

Locations

AU (1); CH (4)