Clinical trial NCT05395598: Incidence of Major Complication in Case of Thoracic Aortic Aneurysm
Official title: Predicting Moderate Thoracic Aortic Aneurysm Evolution: a Longitudinal Study of Systemic Factors in Patients Free of Connective Tissue Disease. .
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Thoracic Aortic Aneurysm
Keywords: Thoracic aortic aneurysm
Incidence
nocturnal hypertension
Sleep apnea
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Santelys Association
name: Région Nord-Pas de Calais, France
name: Association de Cardiologie Nord-Pas de Calais
First posted: 2022-05-27
Enrollment: 320
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with moderate thoracic aortic aneurysms for primary prevention

Brief summary: 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)

Primary outcomes:
measure: Occurrence within 5 years of inclusion of a major aortic even
timeFrame: during the 5 years after inclusion
Secondary outcomes:
measure: Number of Participants with controlled blood pressure defined by ambulatory blood pressure measurement
timeFrame: during the 2 years after inclusion
measure: Presence of sleep disorders defined by an 'Apnea Hypopnea Index and/or an Oxygen Desaturation Index
timeFrame: during the 2 years after inclusion
measure: Occurrence during the 5 years after inclusion of a major cardiovascular event
timeFrame: during the 5 years after inclusion
Other outcomes:
Locations:
city: Lille
country: France
facility: CHU Lille
state: Please Choose...
Study officials:
affiliation: University Hospital, Lille
name: Pascal DELSART, MD
role: PRINCIPAL_INVESTIGATOR
References: