NCT01599533

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
345

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 16, 2012

Completed
16 days until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

December 2, 2019

Status Verified

October 1, 2019

Enrollment Period

5.1 years

First QC Date

April 10, 2012

Last Update Submit

November 28, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • BLOOD SAMPLES

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

    3 YEARS

Secondary Outcomes (2)

  • ANGIOSCAN

    3 YEARS

  • CARDIAC STATEMENT

    3 YEARS

Study Arms (1)

abdominal aortic aneurysms

OTHER
Other: blood samples

Interventions

abdominal aortic aneurysms

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • BERNARD BELAIGUES

    Assistance Publique hôpitaux de Marseille

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2012

First Posted

May 16, 2012

Study Start

June 1, 2012

Primary Completion

July 1, 2017

Study Completion

July 1, 2018

Last Updated

December 2, 2019

Record last verified: 2019-10

Locations