NCT05395598 Incidence of Major Complication in Case of Thoracic Aortic Aneurysm
| NCT ID | NCT05395598 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Lille |
| Condition | Thoracic Aortic Aneurysm |
| Study Type | OBSERVATIONAL |
| Enrollment | 320 participants |
| Start Date | 2024-04-18 |
| Primary Completion | 2031-04-18 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 320 participants in total. It began in 2024-04-18 with a primary completion date of 2031-04-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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)
Contact & Investigator
Pascal DELSART, MD
PRINCIPAL INVESTIGATOR
University Hospital, Lille
Frequently Asked Questions
Who can join the NCT05395598 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, up to 80 Years, studying Thoracic Aortic Aneurysm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05395598 currently recruiting?
Yes, NCT05395598 is actively recruiting participants. Contact the research team at pascal.DELSART@chru-Lille.fr for enrollment information.
Where is the NCT05395598 trial being conducted?
This trial is being conducted at Lille, France.
Who is sponsoring the NCT05395598 clinical trial?
NCT05395598 is sponsored by University Hospital, Lille. The principal investigator is Pascal DELSART, MD at University Hospital, Lille. The trial plans to enroll 320 participants.