Development of Novel Imaging Markers Predicting the Progression of Abdominal Aortic Aneurysm Using 3D Computed Tomography

Study Overview
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Brief Summary
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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
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Prospective single-arm multicenter registry

Official Title
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Development of Novel Imaging Markers Predicting the Progression of Abdominal Aortic Aneurysm Using 3D Computed Tomography

Conditions
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Abdominal Aortic Aneurysm (AAA)

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| small AAA patients<br>all patients with small AAA | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse aorta-related events | Composite event of death, aortic rupture, or aneurysm growth >0.4 cm per year | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of clinical events | death, aortic rupture, aneurysm growth >0.4 cm per year, surgical or endovascular repair | 1 year | 
| Change in CT parameter of aneurysm | diameter | 1 year | 
| Change in CT parameter of aneurysm | volume | 1 year | 
| Change in CT parameter of aneurysm | wall shear stress | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CT, abdominal Aortic Aneurysm, risk factor