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

March 24, 2024 updated by: Yonsei University

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

Study Overview

Status

Completed

Conditions

Detailed Description

Prospective single-arm multicenter registry

Study Type

Observational

Enrollment (Actual)

323

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Young-Guk Ko, M.D.
  • Phone Number: 82-2-2228-8460
  • Email: ygko@yuhs.ac

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Division of Cardiology, Severance Cardiovascular Hospital
        • Contact:
          • Young-Guk Ko, M.D.
          • Phone Number: 82-2-2228-8460
          • Email: ygko@yuhs.ac

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
small AAA patients
all patients with small AAA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major adverse aorta-related events
Time Frame: 1 year
Composite event of death, aortic rupture, or aneurysm growth >0.4 cm per year
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of clinical events
Time Frame: 1 year
death, aortic rupture, aneurysm growth >0.4 cm per year, surgical or endovascular repair
1 year
Change in CT parameter of aneurysm
Time Frame: 1 year
diameter
1 year
Change in CT parameter of aneurysm
Time Frame: 1 year
volume
1 year
Change in CT parameter of aneurysm
Time Frame: 1 year
wall shear stress
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2020

Primary Completion (Actual)

April 17, 2023

Study Completion (Actual)

April 17, 2023

Study Registration Dates

First Submitted

March 31, 2020

First Submitted That Met QC Criteria

April 2, 2020

First Posted (Actual)

April 3, 2020

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 24, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2019-0443

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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