Aortic DissectionFESDAUNCT05897476
Prospective Feasibility Study of Point-of-care Ultrasound in Suspected Aortic Dissection
A study testing ultrasound in people with Aortic Dissection and Emergency Ultrasound, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
Aortic dissection is an uncommon and serious pathology. Its diagnosis is difficult because of the varied and silent clinical presentations. The development of ultrasound in emergency medicine is an asset in certain pathologies. Read more about this study
- Who is it for?
- Ages 18 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Aortic Dissection, Emergency Ultrasound
- What is being tested?
- ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteFrance
- Study dates
- 8 Sep 2023to 25 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women aged 18-95 years included
- Non-opposition of the subject to participate in the study
- All patients admitted to the emergency department of the Besançon University Hospital With chest, abdominal, back, lumbar pain, or acute headache
- AORTA score ≥ 1
- Clinical suspicion of AD by the emergency physician
Who cannot join
- Legal incapacity or limited legal capacity
- Subject unlikely to cooperate with the study and/or poor cooperation anticipated by the investigator
- Subject without health insurance
- Pregnant woman
- ECG showing acute coronary syndrome and/or ventricular rhythm disturbances
- Traumatic context, or traumatic cause of pain
- Chronic / subacute dissection (patient with incidental discovery of aortic dissection (city assessment) and then referred to the emergency room).
- Patient refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Aortic dissection is an uncommon and serious pathology. Its diagnosis is difficult because of the varied and silent clinical presentations. The development of ultrasound in emergency medicine is an asset in certain pathologies. The aim of this study is therefore to study the feasibility of a protocol integrating clinical ultrasound in the suspicion of acute aortic dissection in the hospital setting. This study is a single-center prospective interventional study. In which the investigators perform ultrasound in patients with suspected acute aortic dissection in the emergency department. If the protocol is feasible and if it allows a saving of time in the diagnosis or an increase in diagnoses, the investigators will be able to evoke a profitability to the systematic realization of this examination.
Read the detailed description
H0: patient selection and inclusion:
- Presentation of the study
- Delivery of the information note / no objection to the patient if he/she is in a state to consent
- Emergency procedure:
In accordance with article L-1122-1-3 of the public health code, patients may be included in the study at the initiative of the physician without seeking prior consent. This procedure will be associated with a prior call to the relatives to obtain an oral consent in principle (traced in the patient's medical file), while waiting for the delivery of the information note / no objection to the relatives and then to the patient as soon as his condition allows it.
H1: inclusion interview then :
Medical interrogation (retrospective collection if already done / but additional requests if missing data).
Clinical examination (complementary if missing data).
Ultrasound with 3 ultrasound sections to be performed: parasternal long axis, supra-sternal and abdominal, looking for the following signs:
Direct signs: presence of an intimal flap, intramural aortic hematoma > 5mm, penetrating aortic ulcer.
Indirect signs: pericardial effusion, aortic dilatation ≥ 4 cm, tamponade (1).
H4: retrospective collection of the results of complementary examinations if any, biological and radiological, and collection of the final diagnosis retained.
- Conditions
- Aortic Dissection, Emergency Ultrasound
- Being tested
- ultrasound
- Medical subject headings
- Aortic Dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundOther
brief external ultrasound will be proceed on each patient included searching signs of aortic dissection
| Study group | Role | What they receive |
|---|---|---|
| ultrasound arm | Experimental | every patient will be examine with ultrasound Receives: Other: ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful completion of FESDAU protocol.
The statistical analysis on the primary endpoint will be a percentage of success in completing the FESDAU protocol among all eligible individuals.
Measured: 15 minutes
Secondary outcomes (3)
time to diagnosis
time to diagnosis with FESDAU protocol
Measured: 24 hours
Time to perform the ultrasound
during of processing ultrasound
Measured: 60 minutes
Ultrasound slices with a suggestive sign
wich slices are the most interesting
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start8 Sep 2023
- Primary completion24 Dec 2023
- Study completion25 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic DissectionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective single-center interventional diagnostic H1: inclusion interview then : Medical interrogation (retrospective collection if already done / but additional requests if missing data). Clinical examination (complementary if missing data). Ultrasound with 3 ultrasound sections to be performed: parasternal long axis, supra-sternal and abdominal, looking for the following signs: Direct signs: presence of an intimal flap, intramural aortic hematoma \> 5mm, penetrating aortic ulcer. Indirect signs: pericardial effusion, aortic dilatation ≥ 4 cm, tamponade (1). H4: retrospective collection of the results of complementary examinations if any, biological and radiological, and collection of the final diagnosis retained.
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
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
- NCT05897476
- Sponsor's protocol ID
- 2023/781
- Acronym
- FESDAU
- Status last verified
- May 2023
- First submitted
- 26 May 2023
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Feasibility Study of Point-of-care Ultrasound in Suspected Aortic Dissection
- ClinicalTrials.gov ID
- NCT05897476
- Acronym / sponsor ID
- FESDAU / 2023/781
- Conditions
- Aortic Dissection, Emergency Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 8 Sep 2023 (actual)
- Primary completion
- 24 Dec 2023 (actual)
- Study completion
- 25 Dec 2023 (actual)
- First posted
- 9 Jun 2023 (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.
Aortic dissection is an uncommon and serious pathology. Its diagnosis is difficult because of the varied and silent clinical presentations. The development of ultrasound in emergency medicine is an asset in certain pathologies. The aim of this study is therefore to study the feasibility of a protocol integrating clinical ultrasound in the suspicion of acute aortic dissection in the hospital setting. This study is a single-center prospective interventional study. In which the investigators perform ultrasound in patients with suspected acute aortic dissection in the emergency department. If the protocol is feasible and if it allows a saving of time in the diagnosis or an increase in diagnoses, the investigators will be able to evoke a profitability to the systematic realization of this examination.
Detailed description
H0: patient selection and inclusion:
- Presentation of the study
- Delivery of the information note / no objection to the patient if he/she is in a state to consent
- Emergency procedure:
In accordance with article L-1122-1-3 of the public health code, patients may be included in the study at the initiative of the physician without seeking prior consent. This procedure will be associated with a prior call to the relatives to obtain an oral consent in principle (traced in the patient's medical file), while waiting for the delivery of the information note / no objection to the relatives and then to the patient as soon as his condition allows it.
H1: inclusion interview then :
Medical interrogation (retrospective collection if already done / but additional requests if missing data).
Clinical examination (complementary if missing data).
Ultrasound with 3 ultrasound sections to be performed: parasternal long axis, supra-sternal and abdominal, looking for the following signs:
Direct signs: presence of an intimal flap, intramural aortic hematoma > 5mm, penetrating aortic ulcer.
Indirect signs: pericardial effusion, aortic dilatation ≥ 4 cm, tamponade (1).
H4: retrospective collection of the results of complementary examinations if any, biological and radiological, and collection of the final diagnosis retained.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective single-center interventional diagnostic H1: inclusion interview then : Medical interrogation (retrospective collection if already done / but additional requests if missing data). Clinical examination (complementary if missing data). Ultrasound with 3 ultrasound sections to be performed: parasternal long axis, supra-sternal and abdominal, looking for the following signs: Direct signs: presence of an intimal flap, intramural aortic hematoma > 5mm, penetrating aortic ulcer. Indirect signs: pericardial effusion, aortic dilatation ≥ 4 cm, tamponade (1). H4: retrospective collection of the results of complementary examinations if any, biological and radiological, and collection of the final diagnosis retained.
| Arm | Type | Receives |
|---|---|---|
| ultrasound arm | Experimental | Other: ultrasoundevery patient will be examine with ultrasound |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women aged 18-95 years included
- Non-opposition of the subject to participate in the study
- All patients admitted to the emergency department of the Besançon University Hospital With chest, abdominal, back, lumbar pain, or acute headache
- AORTA score ≥ 1
- Clinical suspicion of AD by the emergency physician
Key exclusion criteria (8 listed)
- Legal incapacity or limited legal capacity
- Subject unlikely to cooperate with the study and/or poor cooperation anticipated by the investigator
- Subject without health insurance
- Pregnant woman
- ECG showing acute coronary syndrome and/or ventricular rhythm disturbances
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasoundbrief external ultrasound will be proceed on each patient included searching signs of aortic dissection | Other | ultrasound arm |
Primary outcome
Successful completion of FESDAU protocol.
Time frame: 15 minutes
The statistical analysis on the primary endpoint will be a percentage of success in completing the FESDAU protocol among all eligible individuals.
3 secondary outcomes
time to diagnosis
Time frame: 24 hours
Time to perform the ultrasound
Time frame: 60 minutes
Ultrasound slices with a suggestive sign
Time frame: 60 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound in people with Aortic Dissection and Emergency Ultrasound, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
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 5 inclusion and 8 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: finished, as of the sponsor's last update on 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Successful completion of FESDAU protocol. (time frame: 15 minutes). 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 31 Dec 2024.