Abdominal Aortic Aneurysm (AAA)
Conditions
Keywords
abdominal Aortic Aneurysm, CT, risk factor
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
Interventions
None listed
Sponsors
Yonsei University
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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 * Life expectancy \< 1 year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse aorta-related events | 1 year | Composite event of death, aortic rupture, or aneurysm growth \>0.4 cm per year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of clinical events | 1 year | death, aortic rupture, aneurysm growth \>0.4 cm per year, surgical or endovascular repair |
| Change in CT parameter of aneurysm | 1 year | diameter |
Countries
South Korea
Outcome results
None listed