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Incidence of Major Complication in Case of Thoracic Aortic Aneurysm
NCT05395598 · University Hospital, Lille
In plain English
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Official title
Predicting Moderate Thoracic Aortic Aneurysm Evolution: a Longitudinal Study of Systemic Factors in Patients Free of Connective Tissue Disease. .
About this study
Thoracic aneurysm is a silent disease with a potential mid-term high risk of death or major complications. Few data are available on the real incidence of major complications in case of small and moderate thoracic aneurysm. Different factors are supposed to increase the risk of aortic enlargement as high blood pressure and sleep disorder breathing. The modality of imaging and clinical follow-up are well defined. In this prospective observational study, the aim to assess the incidence of of major complications during follow-up in a population of patients with a small or moderate thoracic aneurysm. The study will also try to identify systemic factors influencing aneurysm evolution.
Eligibility criteria
Inclusion Criteria:
* Documentation of an aortic root aneurysm \> 40 mm
* Agreement to participate to a longitudinal study and available for a 5 years follow-up
Exclusion Criteria:
* Presence of comorbidities or pathology with a prognosis of less than 1 year
* Personal or family history of genetically documented elastic tissue disease or patient meeting the GAND clinical criteria suggestive of Marfan disease
* High-grade mitra-aortic valve disease, even if asymptomatic
* Unbalanced hypertension ≥ 180/110 mmHg
* Aneurysm (regardless of thoracic or abdominal location) ≥ 50 mm
* Aneurysm (regardless of thoracic or abdominal location) with documented progression of more than 5 mm over one year
* History of aortic surgery or endovascular intervention and history of type B aortic dissection of medical treatment
* Renal insufficiency on dialysis, or GFR\< 30 ml/mn (CKD-EPI)
Study design
Enrollment target: 320 participants
Age groups: adult, older_adult
Timeline
Starts: 2024-04-18
Estimated completion: 2031-10
Last updated: 2026-05-15
Primary outcomes
- • Occurrence within 5 years of inclusion of a major aortic even (during the 5 years after inclusion)
Sponsor
University Hospital, Lille · other
With: Santelys Association, Région Nord-Pas de Calais, France, Association de Cardiologie Nord-Pas de Calais
Contacts & investigators
ContactPascal DELSART, MD · contact · pascal.DELSART@chru-Lille.fr · 0320445962
InvestigatorPascal DELSART, MD · principal_investigator, University Hospital, Lille
All locations (1)
CHU LilleRecruiting
Lille, Please Choose..., France