RecruitingNot Applicable

Incidence of Major Complication in Case of Thoracic Aortic Aneurysm

France320 participantsStarted 2024-04-18

Plain-language 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.

Who can participate

Age range

45 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Occurrence within 5 years of inclusion of a major aortic even

Timeframe: during the 5 years after inclusion

Trial details

NCT IDNCT05395598

SponsorUniversity Hospital, Lille

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2031-04-18

Contact for this trial

Pascal DELSART, MD

0320445962 pascal.DELSART@chru-Lille.fr

View on ClinicalTrials.gov More Thoracic Aortic Aneurysm trials