Image

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

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

Recruiting
40-85 years
All
Phase N/A

Powered by AI

Overview

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.

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

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.

Study details
    Myocardial Injury
    Myocardial Infarction
    Perioperative Complication

NCT05859620

University Hospital, Basel, Switzerland

8 March 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.