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Screening for Thoracic Aortic Aneurysm Among a Cohort of Patients With a Degenerative Abdominal Aortic Aneurysm

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ClinicalTrials.gov Identifier: NCT01599533
Recruitment Status : Unknown
Verified September 2016 by Assistance Publique Hopitaux De Marseille.
Recruitment status was:  Recruiting
First Posted : May 16, 2012
Last Update Posted : October 18, 2016
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

April 10, 2012
May 16, 2012
October 18, 2016
June 2012
February 2017   (Final data collection date for primary outcome measure)
BLOOD SAMPLES [ Time Frame: 3 YEARS ]
to determine the prevalence thoracic aortic aneurysms (TAA) and abdominal aortic aneurysms (AAA)
Same as current
Complete list of historical versions of study NCT01599533 on ClinicalTrials.gov Archive Site
  • ANGIOSCAN [ Time Frame: 3 YEARS ]
    the validation of volumetric criteria to quantify the aortic remodeling in TAA or untreated AAA
  • CARDIAC STATEMENT [ Time Frame: 3 YEARS ]
    cardiac echography
Same as current
Not Provided
Not Provided
 
Screening for Thoracic Aortic Aneurysm Among a Cohort of Patients With a Degenerative Abdominal Aortic Aneurysm
Screening for Thoracic Aortic Aneurysm Among a Cohort of Patients With a Degenerative Abdominal Aortic Aneurysm : Prevalence, Description of the Different Thoracic Aortic Phenotypes by Aortic Volumetric Numerized Imaging and Their Relationship With Epidemiologic, Clinical, Biological and Genetic Factors
Many publications deal with the natural history of aortic aneurysms in literature. Except for connective tissue disorders as Marfan or Loeys-Dietz syndrome, aortic aneurysms are a complex multifactorial disease with genetic and environmental risk factors. Susceptibility loci identified in thoracic aortic aneurysms (TAA) and abdominal aortic aneurysms (AAA) do not overlap, suggesting that different genetic risk factors contribute to these two forms of aneuryms. With a higher prevalence correlated to ageing (5%), AAA is usually presented as the degenerative form of the disease. However, a recent epidemiologic study by Olsson et al. has revealed an increasing incidence of thoracic aortic disease among older individuals (70+/-12 years) with 60% of aneurysmal rupture or dissection at diagnosis, and a 1.7 :1 male-to-female ratio compared to 6:1 in AAA. From this current knowledge arises the concept of diffuse or plurisegmental degenerative aneurysmal aortic disease, poorly explored so far. As regards to the prevention policy, there is a consensus statement in which ultrasonography screening for AAA is recommended for all individuals aged > 60 years (particularly in men who have ever smoked) and for those aged > 50 years with family history of AAA. Nevertheless, screening for a concomittant thoracic location of the disease (except thoracoabdominal aneurysm) is not yet required, whereas it could change the prognosis of the patients and influence their management.
Through the constitution of a multicentric prospective cohort of patients with infra-renal AAA (n=450), the investigators aimed to determine the prevalence of a concomitant TAA, and the epidemiologic, clinical, biological and genetic factors related to this aortic phenotype. Therefore, the investigators postulate for a prevalence of the AAA-TAA association inferior or equal to 15%. By the use of an innovating software (AMIRA) to analyse scans, the investigators will perform reproductive measurements of segmental diameters from a segmental aortic volumetric numerized imaging, and describe the different thoracic aortic phenotypes associated with AAA, including the form (TAA, penetrating ulcer, dolichoaorta …) and the location of the disease.
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Abdominal Aortic Aneurysms
Other: blood samples
abdominal aortic aneurysms
Intervention: Other: blood samples
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
500
Same as current
March 2017
February 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Major subject at the time of the inclusion
  • Subject sent in hospitalization or in consultation of surgery vascular for coverage of the first one anévrysme of the sub-renal abdominal aorta degenerative, without anomaly associated by the coeliac aorta, and by the upper diameter in 40mm (according to the criteria of measure recommended for the analysis in echography doppler or in angioscanner).
  • subject not presenting contraindication to the realization of the diagnostic examination by aortic angioscanner
  • Subject having signed a consent.

Exclusion Criteria:

Subject under age 18

  • pregnant Woman
  • Subject received in the phase aigue of a break or a fissuring of an AAA under renal
  • Subject already operated for a thoracic or abdominal aortic anévrysme
  • Subject presenting at least one of the following pathologies:
  • heart disorder valvulaire aortic: aortic incapacity of rank superior to 2, tight aortic stenosis, prosthesis valvulaire aortic
  • context of bicuspidie station wagon diagnosed on at least 2 parents of the first degree
  • of a not degenerative aortopathie anévrysmale bound(connected) in bicuspidie aortic, or: A dissection of type(chap) A or of type(chap) B
  • Of a degenerative aortopathie of type anévrysme thoracoabdominal (in particular, affected by the coeliac aorta, defined by the segment enter the diaphragmatique crossing and the renal arteries)
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01599533
2011-A00042-41
2012-01 ( Other Identifier: AP HM )
No
Not Provided
Not Provided
Assistance Publique Hopitaux De Marseille
Assistance Publique Hopitaux De Marseille
Not Provided
Study Director: BERNARD BELAIGUES Assistance Publique hôpitaux de Marseille
Assistance Publique Hopitaux De Marseille
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP