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

Abdominal Aortic Aneurysm (AAA) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04333641
• Other study ID #: 4-2019-0443
• Status: Completed
• Start date: April 3, 2020
• Est. completion date: April 17, 2023

Study information

• Verified date: March 2024
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Description:

Prospective single-arm multicenter registry

Recruitment information / eligibility

• Status: Completed
• Enrollment: 323
• Est. completion date: April 17, 2023
• Est. primary completion date: April 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm (AAA)
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Locations

Country	Name	City	State
Korea, Republic of	Division of Cardiology, Severance Cardiovascular Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse aorta-related events	Composite event of death, aortic rupture, or aneurysm growth >0.4 cm per year	1 year
Secondary	Number of clinical events	death, aortic rupture, aneurysm growth >0.4 cm per year, surgical or endovascular repair	1 year
Secondary	Change in CT parameter of aneurysm	diameter	1 year
Secondary	Change in CT parameter of aneurysm	volume	1 year
Secondary	Change in CT parameter of aneurysm	wall shear stress	1 year