Incidence of Major Complication in Case of Thoracic Aortic Aneurysm

Study Overview
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Brief Summary
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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.

Official Title
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Predicting Moderate Thoracic Aortic Aneurysm Evolution: a Longitudinal Study of Systemic Factors in Patients Free of Connective Tissue Disease. .

Conditions
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Thoracic Aortic Aneurysm

Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence within 5 years of inclusion of a major aortic even | This composite end point is defined as the occurrence of: Aneurysm-related death Emergency surgery for threatened aortic rupture or aortic dissection Scheduled surgery for aneurysmal dilatation of more than 5 mm over 1 year Aneurysm progression exceeding 55 mm in diameter Root surgery for management of symptomatic aortic valve disease (insufficiency or narrowing) of high grade defined by tight aortic narrowing (V Max≥4 m/s, mean gradient ≥40mmHg, and area ≤1cm² or severe aortic insufficiency (regurgitated volume≥60 ml, shortening fraction≥ 50%. | during the 5 years after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with controlled blood pressure defined by ambulatory blood pressure measurement | The blood pressure measurement (averaged over 24 h)<130/80 mmHg and nocturnal blood pressure ≤120/70 mmHg | during the 2 years after inclusion | 
| Presence of sleep disorders defined by an 'Apnea Hypopnea Index and/or an Oxygen Desaturation Index | for Apnea Hypopnea Index = ≥5 events per hour for Oxygen Desaturation Index = ≥5 events per hour | during the 2 years after inclusion | 
| Occurrence during the 5 years after inclusion of a major cardiovascular event | This composite criterion is defined by the occurrence of death from cardiovascular causes, myocardial infarction, stroke (ischemic or hemorrhagic), or hospitalization for heart failure | during the 5 years after inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thoracic aortic aneurysm, Incidence, nocturnal hypertension, Sleep apnea