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

NCT04333641 | Completed

• 1 other identifier: 4-2019-0443
• Study Type: observational
• Target: 323
• Locations: 1 country
• Sites: 1

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

Conditions

Abdominal Aortic Aneurysm (AAA)

Keywords

abdominal Aortic Aneurysm; CT; risk factor

Outcome Measures

Primary Outcomes (1)

• Major adverse aorta-related events

  Composite event of death, aortic rupture, or aneurysm growth \>0.4 cm per year

  1 year

Secondary Outcomes (4)

• Number of clinical events

  1 year

• Change in CT parameter of aneurysm

  1 year

• Change in CT parameter of aneurysm

  1 year

• Change in CT parameter of aneurysm

  1 year

Study Arms (1)

small AAA patients

all patients with small AAA

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with small abdominal aortic aneurysm with maximal aneurysm of 30 \~50 mm

You may qualify if:

• \- abdominal aortic aneurysm with maximum diameter of 30-50 mm

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Division of Cardiology, Severance Cardiovascular Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2020
• First Posted: April 3, 2020
• Study Start: April 3, 2020
• Primary Completion: April 17, 2023
• Study Completion: April 17, 2023
• Last Updated: March 26, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)