Incidence of Major Complication in Case of Thoracic Aortic Aneurysm

Recruiting

• Conditions: Thoracic Aortic Aneurysm

• Registration Number: NCT05395598
• Lead Sponsor: University Hospital, Lille

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-24
• Study First Submitted QC: 2022-05-24
• Study First Posted: 2022-05-27
• Study Start: 2024-04-18
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-19
• Last Update Posted: 2024-06-24
• Primary Completion: 2031-04-18
• Study Completion: 2031-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 320

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence within 5 years of inclusion of a major aortic even	during the 5 years after inclusion	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%.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHU Lille; 🇫🇷 Lille, Please Choose..., France