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.
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.
- Conditions
- Acute Aortic Syndrome
- 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 group | Role | What they receive |
|---|---|---|
| AAS+ Group | Cases | |
| AAS- Group | Controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted12 Mar 2026
- Study startApr 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Aortic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07467486
- Acronym / sponsor ID
- EnvScore Aorte / 2025/1012
- Conditions
- Acute Aortic Syndrome
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 580 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AAS+ Group | – | –Cases |
| AAS- Group | – | –Controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- 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.
Key inclusion criteria (6 listed)
- 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.-
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Acute Aortic Syndrome
Active, not recruiting
GORE® Ascending Stent Graft in the Treatment of De Novo Type A Aortic Dissections
Aortic Dissection
Recruiting
GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study
Aortic Arch Dissection, Aortic Arch Aneurysm
Enrolling by invitation
Endovascular Treatment of Thoracic Aortic Disease
Thoracic Aortic Aneurysms, Dissecting, Aneurysm
RecruitingObservational study
Potential Diagnostic Biomarkers for Aortic Dissection in the Emergency Department
Aortic Dissection
Not yet recruiting
A Novel Wire-Reinforced Fenestration of a Hybrid Frozen Elephant Trunk Device for Supra-Aortic Branch Vessel Stenting During Aortic Arch Replacement
Aortic Aneurysm, Aortic Dissection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
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.