- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01259843
French National Observatory of Aortic Syndromes (ONSAA)
August 6, 2019 updated by: Elbaz Meyer, French Cardiology Society
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 Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
280
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
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.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical picture
Time Frame: 1 day
|
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.
|
1 day
|
Diagnostic tests
Time Frame: 1 day
|
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.
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Elbaz Meyer, Assistance Publique - Hôpitaux de Paris
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2008
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
December 13, 2010
First Submitted That Met QC Criteria
December 13, 2010
First Posted (Estimate)
December 14, 2010
Study Record Updates
Last Update Posted (Actual)
August 7, 2019
Last Update Submitted That Met QC Criteria
August 6, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07387
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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