Development of Novel Imaging Markers Predicting the Progression of Abdominal Aortic Aneurysm Using 3D Computed Tomography
NCT ID: NCT04333641
Last Updated: 2024-03-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
323 participants
OBSERVATIONAL
2020-04-03
2023-04-17
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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small AAA patients
all patients with small AAA
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
19 Years
ALL
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Locations
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Division of Cardiology, Severance Cardiovascular Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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4-2019-0443
Identifier Type: -
Identifier Source: org_study_id
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