Brief Title
Development of Novel Imaging Markers Predicting the Progression of Abdominal Aortic Aneurysm Using 3D Computed Tomography
Official Title
Development of Novel Imaging Markers Predicting the Progression of Abdominal Aortic Aneurysm Using 3D Computed Tomography
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
Study Type
Observational
Primary Outcome
Major adverse aorta-related events
Secondary Outcome
Number of clinical events
Condition
Abdominal Aortic Aneurysm (AAA)
Study Arms / Comparison Groups
small AAA patients
Description: all patients with small AAA
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
323
Start Date
April 2020
Completion Date
June 2022
Primary Completion Date
June 2022
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 - Life expectancy < 1 year
Gender
All
Ages
19 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, 82-2-2228-8460, [email protected]
Location Countries
Korea, Republic of
Location Countries
Korea, Republic of
Administrative Informations
NCT ID
NCT04333641
Organization ID
4-2019-0443
Responsible Party
Sponsor
Study Sponsor
Yonsei University
Study Sponsor
, ,
Verification Date
April 2020