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

Phase

N/A

Condition

Heart Defect

Congestive Heart Failure

Cardiac Disease

Treatment

Patient assessment and follow-up

Clinical Study ID

NCT05859620

2020-02899

Ages 40-85
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Consecutive patients fulfilling the institutional criteria for inclusion into theroutine 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 visceralsurgery.

Exclusion

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 furtheruse during follow-up
Patients declining consent for follow-up will be excluded from follow-up analyses.

Study Design

Patient assessment and follow-up

July 01, 2021

December 31, 2025

Study 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.

Connect with a study center

University Hospital Innsbruck
Innsbruck, Tyrol 6020
Austria
Active - Recruiting
University Hospital Geneva
Geneva, GE 1205
Switzerland
Site Not Available
Cantonal Hospital Lucerne
Lucerne, LU 6000
Switzerland
Active - Recruiting
Canton Hospital Olten
Olten, SO 4600
Switzerland
Site Not Available
Bürgerspital Solothurn
Solothurn, 4500
Switzerland
Active - Recruiting

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