Development of Novel Imaging Markers Predicting the Progression of Abdominal Aortic Aneurysm Using 3D Computed Tomography
Study Details
Study Description
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
Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
Prospective single-arm multicenter registry
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
small AAA patients all patients with small AAA |
Outcome Measures
Primary Outcome Measures
- Major adverse aorta-related events [1 year]
Composite event of death, aortic rupture, or aneurysm growth >0.4 cm per year
Secondary Outcome Measures
- 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
- Change in CT parameter of aneurysm [1 year]
volume
- Change in CT parameter of aneurysm [1 year]
wall shear stress
Eligibility Criteria
Criteria
Inclusion Criteria:
- abdominal aortic aneurysm with maximum diameter of 30-50 mm
Exclusion Criteria:
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Age <19 years
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Serum Cr> 1.5mg/dL or eGFR<30 mL/min
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Known allergic reactions to iodine contrast media
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Women in pregnancy or women of childbearing age
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Abdominal aortic aneurysms indicated for endovascular or surgical repair (symptomatic aneurysm or aneurysms with diameter >5cm)
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Saccular type aneurysm, infected or inflammatory aneurysm
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Combined aortic dissection
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Aneurysms associated with genetic or connective tissue diseases (Marfan syndrome, Shprintzen-Goldberg syndrome, Loeys-Dietz syndrome, Takayasu's arteritis, Behcet's disease)
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Past history of surgical or endovascular repair of aorta
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Any surgical or endovascular repair planned within 1 year
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Life expectancy < 1 year
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Division of Cardiology, Severance Cardiovascular Hospital | Seoul | Korea, Republic of |
Sponsors and Collaborators
- Yonsei University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 4-2019-0443