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Acute Aortic SyndromeEnvScore AorteNCT07467486

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

An observational study of Acute Aortic Syndrome, run by Centre Hospitalier Universitaire de Besancon.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Aortic Syndrome
How many people
580 participants
Where
No sites listed yet
Study dates
Apr 2026to Dec 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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.

About this study

Official title: 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:

Read more

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.

Medical subject headings
Acute Aortic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07467486
Study groupRoleWhat they receive
AAS+ GroupCases
AAS- GroupControls

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: From January 2014 to January 2026

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2026
  2. Study startApr 2026 (estimated)
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
580 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07467486
Sponsor's protocol ID
2025/1012
Acronym
EnvScore Aorte
Status last verified
Mar 2026
First submitted
7 Mar 2026
Last updated
12 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Aortic Syndrome, run by Centre Hospitalier Universitaire de Besancon.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Receiver Operating Characteristic (ROC) Curve (AUC) of the AORTAs scores. (time frame: From January 2014 to January 2026). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.

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