Development of a novel risk prediction tool for emergency department patients symptoms of coronary artery disease: A research study protocol.

Abstract

Patients with chest pain and symptoms of acute coronary syndromes (ACS) account for over 600,000 emergency department (ED) visits annually in Canada. Over 80% of these patients do not have ACS, and most are discharged from the ED after a thorough evaluation. However, a large proportion of these patients are referred for outpatient objective cardiac testing after ED discharge, even though their short-term risk for major adverse cardiac events (MACE) such as death, new myocardial infarction or need for revascularization is very small. This contributes to substantial low-value healthcare utilization, and limits access for those patients who are more likely to benefit from objective testing.

Existing risk prediction tools were developed prior to the advent of high-sensitivity cardiac troponin assays, were derived in non-representative populations and, when applied to ED patients with low cardiac troponin concentrations, systematically overestimate short-term risk of (MACE).

This multicenter prospective cohort study will enrol ED patients with chest pain to derive and validate a novel risk prediction tool to accurately identify patients at low risk of MACE and not requiring additional cardiac testing from patients who are likely to benefit from additional cardiac testing. We will enroll 6500 patients at 13 Canadian EDs nd prospectively follow them for 30 days to ascertain a primary outcome of MACE. The risk prediction tool developed in this project will guide safe, efficient, appropriate referrals of ED patients with chest pain.

Competing Interest Statement

ADM has received research funding from Roche Diagnostics Canada.

Funding Statement

This project is supported by a Project Grant from the Canadian Institutes of Health Research (CIHR, PJT-191778).

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The protocol was approved by the University of Calgary Conjoint Health Research Ethics Board (REB-24-0536) with a waiver of the requirement for informed consent.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

All data produced in the present study are available upon reasonable request to the authors

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