Actively Recruiting

Age: 45Years - 80Years
All Genders
ID05395598

Predicting Moderate Thoracic Aortic Aneurysm Evolution: a Longitudinal Study of Systemic Factors in Patients Free of Connective Tissue Disease

Led by University Hospital, Lille · Updated on 2026-05-15

320

Participants Needed

1

Research Sites

23 weeks

Total Duration

On this page

Sponsors

U

University Hospital, Lille

Lead Sponsor

S

Santelys Association

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying thoracic aortic aneurysm, a condition that can be silent but carries a risk of serious complications or death over time. This observational study aims to understand the rate of major complications in patients with small to moderate thoracic aneurysms. It also seeks to identify systemic factors, such as blood pressure and sleep disorders, that might influence the aneurysm's progression. The study follows patients with documented aortic root aneurysms larger than 40 mm but excludes those with larger or rapidly progressing aneurysms or certain medical conditions. Participants will be observed over a five-year period to monitor the occurrence of major aortic events. Blood pressure control and sleep disorders will also be assessed during the first two years. Participants will be involved in regular clinical and imaging follow-ups over five years. Researchers will collect data on major cardiovascular and aortic events, blood pressure control through ambulatory measurements, and sleep disorder indicators like the Apnea Hypopnea Index and Oxygen Desaturation Index. This long-term observation helps understand aneurysm evolution and related risks in this patient group.

CONDITIONS

Brief Title

Incidence of Major Complication in Case of Thoracic Aortic Aneurysm

Who Can Participate

Age: 45Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Documentation of an aortic root aneurysm > 40 mm
  • Agreement to participate in a longitudinal study and available for a 5-year follow-up
  • Age between 45 and 80 years
Not Eligible

You will not qualify if you...

  • Presence of comorbidities or pathology with a prognosis of less than 1 year
  • Personal or family history of genetically documented elastic tissue disease or meeting clinical criteria suggestive of Marfan disease
  • High-grade mitral or aortic valve disease, even if asymptomatic
  • Unbalanced hypertension with blood pressure ≥ 180/110 mmHg
  • Any aneurysm (thoracic or abdominal) ≥ 50 mm
  • Aneurysm with documented progression of more than 5 mm over one year
  • History of aortic surgery, endovascular intervention, or type B aortic dissection treated medically
  • Renal insufficiency on dialysis or with GFR < 30 ml/min (CKD-EPI)

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Long-term Monitoring

Duration - Up to 5 years

Participants are observed over several years to monitor the occurrence of major aortic and cardiovascular events, as well as control of blood pressure and presence of sleep disorders.

Periodic visits over 5 years for assessments and monitoring

Trial Site Locations

Total: 1 location

1

CHU Lille

Lille, Please Choose..., France, 59037

Actively Recruiting

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Research Team

P

Pascal DELSART, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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