Assessing major complications in patients with thoracic aortic aneurysm
Predicting Moderate Thoracic Aortic Aneurysm Evolution: a Longitudinal Study of Systemic Factors in Patients Free of Connective Tissue Disease. .
This study is trying to see how often serious problems happen in people with small to moderate thoracic aortic aneurysms over five years and what factors might affect their condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 320 (estimated) |
| Ages | 45 Years to 80 Years |
| Sex | All |
| Sponsor | University Hospital, Lille Academic / other |
| Locations | 1 site (Lille, Please Choose...) |
| Trial ID | NCT05395598 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the incidence of major complications in patients diagnosed with small to moderate thoracic aortic aneurysms over a five-year follow-up period. It will investigate various systemic factors, such as high blood pressure and sleep disorders, that may influence the progression of the aneurysm. Participants will undergo regular imaging and clinical assessments to monitor their condition and identify any complications that arise. The study seeks to fill the gap in existing data regarding the risks associated with thoracic aortic aneurysms.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals with a documented thoracic aortic aneurysm greater than 40 mm who can commit to a five-year follow-up.
Not a fit: Patients with significant comorbidities, advanced aneurysm progression, or a history of aortic surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the management and monitoring of patients with thoracic aortic aneurysms, potentially improving patient outcomes.
How similar studies have performed: While there is limited data on the specific incidence of complications in small to moderate thoracic aortic aneurysms, similar observational studies have provided valuable insights into aneurysm management.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Lille, Please Choose...
- CHU Lille — Lille, Please Choose..., France (Recruiting)
Study contacts
- Principal investigator: Pascal DELSART, MD — University Hospital, Lille
- Study coordinator: Pascal DELSART, MD
- Email: pascal.DELSART@chru-Lille.fr
- Phone: 0320445962
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.