The EnvScore-Aorte Diagnostic Study Protocol for the Identification of Acute Aortic Syndrome

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Besancon

About this trial

The goal of this retrospective observational study is to evaluate the diagnostic performance of the AORTAs score integrated with environmental exposure data (AORTAs-E) for the identification of Acute Aortic Syndrome (AAS) during initial maangement in the emergency departement.

The main question it aims to answer is:

Can the integration of real-time meteorological and atmospheric pollution data improve the early identification of AAS in patients presenting in the emergency department for chest, abdominal, or back pain?

Researchers will analyze medical records and environmental data for 580 adult patients (290 cases with confirmed AAS and 290 controls) managed at the University Hospital of Besançon between 2014 and 2026. Environmental exposure, including temperature and pollutant concentrations, will be calculated based on each patient's residential address to determine if adding these factors to clinical data increases diagnostic accuracy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults (>18 years)

Diagnosis of AAS (aortic dissection, intramural hematoma, or penetrating atherosclerotic ulcer) identified according to medicalization programs for information systems

Diagnosis confirmed by imaging (CTA, TTE, or TOE)

Adults (>18 years)

Disqualifiers

Post-traumatic or iatrogenic AAS.

Subacute (8-30 days) or chronic symptoms (>30 days).

Patients under legal protection or unable to provide consent/non-opposition.

Trial population

The study population consists of 580 adult patients (\>18 years) who presented to the emergency department of the University Hospital (CHU) of Besançon, France, with acute chest, abdominal, or back pain. This cohort is divided into two groups of 290 participants each: a "diseased" group (AAS+) and a "non-diseased" group (AAS-). The case group includes patients with a confirmed diagnosis of acute aortic syndrome (aortic dissection, intramural hematoma, or penetrating atherosclerotic ulcer) verified by imaging. The control group includes patients with similar clinical presentations in whom AAS was ruled out by computed tomography angiography (CTA). All participants must have been admitted between January 1, 2014, and January 1, 2026, and must have undergone a thoracic or abdominal-pelvic CTA to ensure diagnostic certainty. Patients with post-traumatic symptoms, chronic conditions lasting more than 30 days, or those under legal protection are excluded from the study.

Trial design

Design model

Case-control

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

580 Participants
are grouped into 2 trial groups
Group A: AAS+ Group
Group B: AAS- Group

Trial outcomes

Primary outcomes

1

Area Under the Receiver Operating Characteristic (ROC) Curve (AUC) of the AORTAs scores.

Comparison of the diagnostic performance between the four scores: original AORTAs, AORTAs-E (Environmental), AORTAs-R (emergency medical dispatch), and AORTAs-R+E (Combined).

Time frame
From January 2014 to January 2026

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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