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CompletedNCT01599533Updated Dec 2, 2019

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

An interventional study of blood samples in Abdominal Aortic Aneurysms, sponsored by Assistance Publique Hopitaux De Marseille. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-02.

Sponsored by Assistance Publique Hopitaux De Marseille · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
345
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Abdominal Aortic Aneurysms
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In context

Aortic Aneurysm, Abdominal

481 studies on the registry are indexed under Aortic Aneurysm, Abdominal; 99 are open to participants now.

This study's enrollment of 345 is above the median of 68 across 236 interventional studies indexed under Aortic Aneurysm, Abdominal.

Browse Aortic Aneurysm, Abdominal studies →

Lead sponsor

Assistance Publique Hopitaux De Marseille is the lead sponsor of 700 studies on the registry; 144 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
345 participants (actual)

Study arms

  • Other
    abdominal aortic aneurysms

    Other: blood samples

Interventions

  • Otherblood samples
06

What researchers measure

Primary outcomes

  1. BLOOD SAMPLES

    to determine the prevalence thoracic aortic aneurysms (TAA) and abdominal aortic aneurysms (AAA)

    Time frame: 3 YEARS

Secondary outcomes

  1. ANGIOSCAN

    the validation of volumetric criteria to quantify the aortic remodeling in TAA or untreated AAA

    Time frame: 3 YEARS

  2. CARDIAC STATEMENT

    cardiac echography

    Time frame: 3 YEARS

07

Study locations

1 site
  • Assistance Publique Hopitaux de Marseille
    Marseille, 13354, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01599533
Responsible party
Sponsor
First posted
May 16, 2012
Start date
Jun 2012
Primary completion
Jul 2017
Completion
Jul 2018
Last update
Dec 2, 2019

Study contacts

BERNARD BELAIGUES
study director · Assistance Publique hôpitaux de Marseille

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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