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OpenTrials
Completed

NCT Number: NCT04333641

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

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

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Key information

Conditions

Abdominal Aortic Aneurysm (AAA) Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Aortic Diseases Cardiovascular Diseases Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Division of Cardiology, Severance Cardiovascular Hospital

Seoul, South Korea

About this study

Prospective single-arm multicenter registry

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Major adverse aorta-related events

    Time frame: 1 year

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

Secondary outcomes

  1. Number of clinical events

    Time frame: 1 year

    death, aortic rupture, aneurysm growth >0.4 cm per year, surgical or endovascular repair

  2. Change in CT parameter of aneurysm

    Time frame: 1 year

    diameter

  3. Change in CT parameter of aneurysm

    Time frame: 1 year

    volume

  4. Change in CT parameter of aneurysm

    Time frame: 1 year

    wall shear stress

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Apr 3, 2020
Registry last updated
Mar 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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