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

March 9, 2026 updated by: Centre Hospitalier Universitaire de Besancon

Diagnostic Performance of a Modified AORTAs Score Integrated With Environmental Exposure Data for Acute Aortic Syndrome Identification : The EnvScore-Aorte Diagnostic Study Protocol

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

580

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study 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.

Description

Inclusion Criteria (Cases - AAS+) :

  • 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)

Inclusion Criteria (Controls - AAS-):

  • Adults (>18 years)
  • Presenting in the emergency department for chest, back, or abdominal pain.-
  • Confirmed differential diagnosis by CTA, ruling out AAS

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
AAS+ Group
Cases
AAS- Group
Controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area Under the Receiver Operating Characteristic (ROC) Curve (AUC) of the AORTAs scores.
Time Frame: From January 2014 to January 2026
Comparison of the diagnostic performance between the four scores: original AORTAs, AORTAs-E (Environmental), AORTAs-R (emergency medical dispatch), and AORTAs-R+E (Combined).
From January 2014 to January 2026

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

March 7, 2026

First Submitted That Met QC Criteria

March 9, 2026

First Posted (Actual)

March 12, 2026

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025/1012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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