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French National Observatory of Aortic Syndromes (ONSAA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Elbaz Meyer, French Cardiology Society
ClinicalTrials.gov Identifier:
NCT01259843
First received: December 13, 2010
Last updated: June 13, 2012
Last verified: June 2012
  Purpose

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.


Condition
Acute Aortic Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: French National Observatory of Aortic Syndromes

Further study details as provided by French Cardiology Society:

Primary Outcome Measures:
  • Etiology of AAS [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Clinical picture [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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.

  • Diagnostic tests [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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.


Enrollment: 280
Study Start Date: August 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01259843

Sponsors and Collaborators
French Cardiology Society
Investigators
Principal Investigator: Elbaz Meyer AP-HP
  More Information

No publications provided

Responsible Party: Elbaz Meyer, Assistant Professor, French Cardiology Society
ClinicalTrials.gov Identifier: NCT01259843     History of Changes
Other Study ID Numbers: 07387
Study First Received: December 13, 2010
Last Updated: June 13, 2012
Health Authority: France: French Data Protection Authority

Keywords provided by French Cardiology Society:
Acute aortic syndrome

Additional relevant MeSH terms:
Syndrome
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014