Acute Aortic SyndromeONSAANCT01259843
French National Observatory of Aortic Syndromes
An observational study of Acute Aortic Syndrome, run by French Cardiology Society.
Trial summary
The study examined the clinical characteristics and conditions of care for patients with acute aortic syndrome (AAS) that will identify patients at risk for increased morbidity and mortality and provide a basis for the eventual achievement of specific studies on the optimal therapeutic management according to… 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
- 280 participants
- Where
- No sites listed yet
- Study dates
- Aug 2008to Dec 2010
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to cardiology, radiology or surgery for a clinical picture suggestive of acute aortic syndrome whose diagnosis was subsequently confirmed in due course of hospitalization by further investigations.
Who may be able to join
- Male or female age (e) over 18 years old
- Patients with a AAS duly authenticated by further tests
- Patients who consented to participate in the study
Who cannot join
- Refusal of consent for study participation and ancillary studies
- AAS occurring in the aftermath of a traumatic thoracic
- Diagnosis AAS aside in favor of an alternative diagnosis
About this study
The study examined the clinical characteristics and conditions of care for patients with acute aortic syndrome (AAS) that will identify patients at risk for increased morbidity and mortality and provide a basis for the eventual achievement of specific studies on the optimal therapeutic management according to different risk profiles. The aim of the Observatory is to provide a photograph "size" of practices in France at present, both in the larger centers than in smaller and optimize diagnostic and therapeutic currently available by the activation pathways of rational management.
- Conditions
- Acute Aortic Syndrome
- Keywords
- 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 |
|---|---|---|
| Acute Aortic Syndrome | Patients admitted to cardiology, radiology or surgery for a clinical picture suggestive of acute aortic syndrome whose diagnosis was subsequently confirmed in due course of hospitalization by further investigations. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Etiology of AAS
Measure the respective contribution of each of the etiologies of AAS (aortic dissection type A aortic dissection type B aortic wall hematoma, penetrating atherosclerotic ulcer, aneurysm of the thoracic aorta complicated).
Measured: 1 day
Secondary outcomes (2)
Clinical picture
Identify and define the specific clinical picture of each of these new entities recently dismembered as part of AAS. Indeed, if the clinical presentation of classic aortic dissection A and B is well known, that of other entities, individualized recently, remains poorly described.
Measured: 1 day
Diagnostic tests
Evaluate the performance and the respective roles of the various diagnostic tests including recent acquisitions little or no invasive; Trans thoracic ultrasound, ultrasound and trans esophageal chest scan.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2010 (estimated)
- Study startAug 2008
- Primary completionDec 2010
- Study completionDec 2010
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- French Cardiology Society
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elbaz Meyer, French Cardiology Society
- Investigators
- Elbaz Meyer, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01259843
- Sponsor's protocol ID
- 07387
- Acronym
- ONSAA
- Status last verified
- Aug 2019
- First submitted
- 13 Dec 2010
- Last updated
- 7 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- French National Observatory of Aortic Syndromes
- ClinicalTrials.gov ID
- NCT01259843
- Acronym / sponsor ID
- ONSAA / 07387
- Conditions
- Acute Aortic Syndrome
- Keywords
- Acute aortic syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- French Cardiology SocietyUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 14 Dec 2010 (estimated)
- 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 study examined the clinical characteristics and conditions of care for patients with acute aortic syndrome (AAS) that will identify patients at risk for increased morbidity and mortality and provide a basis for the eventual achievement of specific studies on the optimal therapeutic management according to different risk profiles. The aim of the Observatory is to provide a photograph "size" of practices in France at present, both in the larger centers than in smaller and optimize diagnostic and therapeutic currently available by the activation pathways of rational management.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute Aortic Syndrome | – | –Patients admitted to cardiology, radiology or surgery for a clinical picture suggestive of acute aortic syndrome whose diagnosis was subsequently confirmed in due course of hospitalization by further investigations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to cardiology, radiology or surgery for a clinical picture suggestive of acute aortic syndrome whose diagnosis was subsequently confirmed in due course of hospitalization by further investigations.
Key inclusion criteria (3 listed)
- Male or female age (e) over 18 years old
- Patients with a AAS duly authenticated by further tests
- Patients who consented to participate in the study
Key exclusion criteria (3 listed)
- Refusal of consent for study participation and ancillary studies
- AAS occurring in the aftermath of a traumatic thoracic
- Diagnosis AAS aside in favor of an alternative diagnosis
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
Etiology of AAS
Time frame: 1 day
Measure the respective contribution of each of the etiologies of AAS (aortic dissection type A aortic dissection type B aortic wall hematoma, penetrating atherosclerotic ulcer, aneurysm of the thoracic aorta complicated).
2 secondary outcomes
Clinical picture
Time frame: 1 day
Diagnostic tests
Time frame: 1 day
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 7 Aug 2019.
Related trials for Acute Aortic Syndrome
Not yet recruitingObservational study
Clinical Health Outcomes Evaluation of Terumo Aortic Hybrid Devices
Aortic Aneurysm and Dissection
Recruiting
GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study
Aortic Arch Dissection, Aortic Arch Aneurysm
Active, not recruiting
GORE® Ascending Stent Graft in the Treatment of De Novo Type A Aortic Dissections
Aortic Dissection
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
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.
Elbaz Meyer principal investigator
Assistance Publique - Hôpitaux de Paris
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Aortic Syndrome, run by French Cardiology Society.
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 3 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: finished, as of the sponsor's last update on 7 Aug 2019. 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?
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?
Etiology of AAS (time frame: 1 day). 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 7 Aug 2019.