Incidence of Major Complication in Case of Thoracic Aortic Aneurysm
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Thoracic Aortic Aneurysm. Basic parameters: 45 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Predicting Moderate Thoracic Aortic Aneurysm Evolution: a Longitudinal Study of Systemic Factors in Patients Free of Connective Tissue Disease. .
Overview
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.
Primary outcome measures
- Occurrence within 5 years of inclusion of a major aortic even [Time frame: during the 5 years after inclusion]
Secondary outcome measures (3)
- Number of Participants with controlled blood pressure defined by ambulatory blood pressure measurement [Time frame: during the 2 years after inclusion]
- Presence of sleep disorders defined by an 'Apnea Hypopnea Index and/or an Oxygen Desaturation Index [Time frame: during the 2 years after inclusion]
- Occurrence during the 5 years after inclusion of a major cardiovascular event [Time frame: during the 5 years after inclusion]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- CHU Lille — Lille
Identifiers
NCT: NCT05395598 · 2021_0151 · 2022-A00439-34