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

Completed

• Conditions: Abdominal Aortic Aneurysm (AAA)

• Registration Number: NCT04333641
• Lead Sponsor: Yonsei University

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 Timeline

• Study First Submitted: 2020-03-31
• Study First Submitted QC: 2020-04-02
• Study Start: 2020-04-03
• Study First Posted: 2020-04-03
• Primary Completion: 2023-04-17
• Study Completion: 2023-04-17
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-24
• Last Update Posted: 2024-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 323

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major adverse aorta-related events	1 year	Composite event of death, aortic rupture, or aneurysm growth \>0.4 cm per year

Secondary Outcome Measures

Name	Time	Method
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	wall shear stress

Trial Locations

Locations (1)

Division of Cardiology, Severance Cardiovascular Hospital; 🇰🇷 Seoul, Korea, Republic of