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NCT Number: NCT05859620

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

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.

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Key information

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Innsbruck, Innsbruck, Tyrol, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Perioperative Myocardial Infarction/Injury (PMI)-Screening (Reach)

    Time frame: during the hospital stay (up to postoperative day 2)

    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)

  2. Incidence of PMI

    Time frame: after the surgery until postoperative day 2

    Percentage of patients experiencing PMI following noncardiac surgery

  3. Cardiology consultation (Fidelity)

    Time frame: during hospital stay (up to postoperative day 5)

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

  4. Diagnostic challenge

    Time frame: during hospital stay (up to postoperative day 5)

    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

  5. Barriers to implementation

    Time frame: following the post-implementation period (6 months after 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

Secondary outcomes

  1. Medicoeconomic impact

    Time frame: Within 3 - 30 days following surgery

    Cost of postoperative blood draws on day 1 and 2, length of hospital stay, days on intensive care unit, consultations within day 1-3, ECG within day 1-3, cardiac stress testing within 30 days, and cardiac catheterisation within 30 days, denoted in Swiss Francs

  2. Resource Usage

    Time frame: Within 3 - 30 days following surgery

    Number of postoperative blood draws on day 1 and 2, length of hospital stay, days on intensive care unit, consultations within day 1-3, ECG within day 1-3, cardiac stress testing within 30 days, and cardiac catheterisation within 30 days

  3. Major adverse cardiac events (MACE)

    Time frame: 1 year

    Occurrence and timing of a composite of major adverse cardiac events (MACE) within twelve months, consisting of: All-cause death, acute myocardial infarction Type 1, survived sudden cardiac death, and Acute heart failure

  4. Complications of cardiology diagnostics

    Time frame: 30 days

    Number of inappropriate interventions or complications of cardiology diagnostics and interventions, consisting of: Overtreatment (Coronary angiographies showing normal coronaries), complications of cardiac interventions (myocardial infarction, stroke, death)

  5. Major bleeding

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

    Bleeding Academic Research Consortium Typ 3-5

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • Bürgerspital Solothurn
  • Kantonsspital Olten
  • Luzerner Kantonsspital
  • Medical University Innsbruck
  • University Hospital, Geneva

Registry information

Official study title

Implementation of a Clinical Screening and Response System for the Early Detection of Cardiac Complications After Noncardiac Surgery: Feasibility and Medicoeconomic Impact

Acronym: ImplementPMI

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
May 16, 2023
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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