Incidence of Major Complication in Case of Thoracic Aortic Aneurysm
ConditionThoracic Aortic Aneurysm
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age45-80
SponsorUniversity Hospital, Lille
About this trial
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
This trial does not accept healthy volunteersQualifiers
Documentation of an aortic root aneurysm > 40 mm
Agreement to participate to a longitudinal study and available for a 5 years follow-up
Disqualifiers
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
Trial population
Patients with moderate thoracic aortic aneurysms for primary prevention
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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%.
Time frame
during the 5 years after inclusionSecondary outcomes
1
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
Time frame
during the 2 years after inclusion2
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
Time frame
during the 2 years after inclusion3
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
Time frame
during the 5 years after inclusionSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Lille
Lead sponsor
Santelys Association
Collaborator
Région Nord-Pas de Calais, France
Collaborator
Association de Cardiologie Nord-Pas de Calais
Collaborator
Source ClinicalTrials.gov