Development of Novel Imaging Markers Predicting the Progression of Abdominal Aortic Aneurysm Using 3D Computed Tomography
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Abdominal Aortic Aneurysm (AAA)
- Sponsor
- Yonsei University
- Enrollment
- 323
- Locations
- 1
- Primary Endpoint
- Major adverse aorta-related events
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Study purpose: This study will investigate anatomical factors associated with increased risk of major adverse aorta-related event and accelerated growth of abdominal aneurysm based on 3-dimensional analysis of CT images.
Study design: a multicenter single-arm prospective observational study.
Subject: patients with small abdominal aortic aneurysm with maximal diameter of 30-50 mm (n=323)
Methods: Patients diagnosed with small AAA based on CT will be enrolled after considering inclusion and exclusion criteria and prospectively followed clinically and with CT at 1 year.
Primary endpoint: Major adverse aorta-related events (death, aortic rupture, or aneurysm growth >0.4 cm per year) at 1 year
Secondary endpoints: 1) clinical events : death, aortic rupture, aneurysm growth >0.4 cm per year, surgical or endovascular repair 2) Changes in CT parameters of aneurysm: diameter, volume, wall shear stress
Detailed Description
Prospective single-arm multicenter registry
Investigators
Eligibility Criteria
Inclusion Criteria
- •abdominal aortic aneurysm with maximum diameter of 30-50 mm
Exclusion Criteria
- •Age \<19 years
- •Serum Cr\> 1.5mg/dL or eGFR\<30 mL/min
- •Known allergic reactions to iodine contrast media
- •Women in pregnancy or women of childbearing age
- •Abdominal aortic aneurysms indicated for endovascular or surgical repair (symptomatic aneurysm or aneurysms with diameter \>5cm)
- •Saccular type aneurysm, infected or inflammatory aneurysm
- •Combined aortic dissection
- •Aneurysms associated with genetic or connective tissue diseases (Marfan syndrome, Shprintzen-Goldberg syndrome, Loeys-Dietz syndrome, Takayasu's arteritis, Behcet's disease)
- •Past history of surgical or endovascular repair of aorta
- •Any surgical or endovascular repair planned within 1 year
Outcomes
Primary Outcomes
Major adverse aorta-related events
Time Frame: 1 year
Composite event of death, aortic rupture, or aneurysm growth \>0.4 cm per year
Secondary Outcomes
- Number of clinical events(1 year)
- Change in CT parameter of aneurysm(1 year)