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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Assistance Publique Hopitaux De Marseille
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT01599533
First received: April 10, 2012
Last updated: September 13, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Abdominal Aortic Aneurysms
Other: blood samples

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • BLOOD SAMPLES [ Time Frame: 3 YEARS ] [ Designated as safety issue: No ]
    to determine the prevalence thoracic aortic aneurysms (TAA) and abdominal aortic aneurysms (AAA)


Secondary Outcome Measures:
  • ANGIOSCAN [ Time Frame: 3 YEARS ] [ Designated as safety issue: No ]
    the validation of volumetric criteria to quantify the aortic remodeling in TAA or untreated AAA

  • CARDIAC STATEMENT [ Time Frame: 3 YEARS ] [ Designated as safety issue: No ]
    cardiac echography


Estimated Enrollment: 500
Study Start Date: June 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
abdominal aortic aneurysms Other: blood samples

Detailed Description:

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.

  Eligibility

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

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)
  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: NCT01599533

Contacts
Contact: philippe PIQUET philippe.piquet@ap-hm.fr

Locations
France
Assistance Publique Hopitaux de Marseille Recruiting
Marseille, France, 13354
Contact: philippe PIQUET       philippe.piquet@ap-hm.fr   
Principal Investigator: philippe piquet         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Study Director: BERNARD BELAIGUES Assistance Publique hôpitaux de Marseille
  More Information

No publications provided

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT01599533     History of Changes
Other Study ID Numbers: 2011-A00042-41, 2012-01
Study First Received: April 10, 2012
Last Updated: September 13, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Aortic Aneurysm, Thoracic
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on July 22, 2014