Screening for Thoracic Aortic Aneurysm Among a Cohort of Patients With a Degenerative Abdominal Aortic Aneurysm
2 other identifiers
interventional
345
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 10, 2012
CompletedFirst Posted
Study publicly available on registry
May 16, 2012
CompletedStudy Start
First participant enrolled
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedDecember 2, 2019
October 1, 2019
5.1 years
April 10, 2012
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
OTHERInterventions
Eligibility Criteria
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
BERNARD BELAIGUES
Assistance Publique hôpitaux de Marseille
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