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

Sponsor
Yonsei University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04333641
Collaborator
(none)
323
1
26
12.4

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Prospective single-arm multicenter registry

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    323 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Development of Novel Imaging Markers Predicting the Progression of Abdominal Aortic Aneurysm Using 3D Computed Tomography
    Anticipated Study Start Date :
    Apr 1, 2020
    Anticipated Primary Completion Date :
    Jun 1, 2022
    Anticipated Study Completion Date :
    Jun 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    small AAA patients

    all patients with small AAA

    Outcome Measures

    Primary Outcome Measures

    1. Major adverse aorta-related events [1 year]

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

    Secondary Outcome Measures

    1. Number of clinical events [1 year]

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

    2. Change in CT parameter of aneurysm [1 year]

      diameter

    3. Change in CT parameter of aneurysm [1 year]

      volume

    4. Change in CT parameter of aneurysm [1 year]

      wall shear stress

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Division of Cardiology, Severance Cardiovascular Hospital Seoul Korea, Republic of

    Sponsors and Collaborators

    • Yonsei University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yonsei University
    ClinicalTrials.gov Identifier:
    NCT04333641
    Other Study ID Numbers:
    • 4-2019-0443
    First Posted:
    Apr 3, 2020
    Last Update Posted:
    Apr 3, 2020
    Last Verified:
    Apr 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Yonsei University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 3, 2020