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

NCT07467486 | Not Yet Recruiting

• 1 other identifier: 2025/1012
• Study Type: observational
• Target: 580
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Acute Aortic Syndrome

Outcome Measures

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).

  From January 2014 to January 2026

Study Arms (2)

AAS+ Group

Cases

AAS- Group

Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

MeSH Terms

Conditions

Acute Aortic Syndrome

Condition Hierarchy (Ancestors)

Aortic Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2026
• First Posted: March 12, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 12, 2026

Record last verified: 2026-03