Abdominal Aortic Aneurysm (AAA)NCT04333641
Development of Novel Imaging Markers Predicting the Progression of Abdominal Aortic Aneurysm Using 3D Computed Tomography
An observational study of Abdominal Aortic Aneurysm (AAA), run by Yonsei University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm (AAA)
- How many people
- 323 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Apr 2020to 17 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with small abdominal aortic aneurysm with maximal aneurysm of 30 ~50 mm
Who may be able to join
- abdominal aortic aneurysm with maximum diameter of 30-50 mm
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Division of Cardiology, Severance Cardiovascular Hospital
Seoul
About this study
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.
Read more
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
Read the detailed description
Prospective single-arm multicenter registry
- Conditions
- Abdominal Aortic Aneurysm (AAA)
- Keywords
- abdominal Aortic Aneurysm, CT, risk factor
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| small AAA patients | all patients with small AAA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse aorta-related events
Composite event of death, aortic rupture, or aneurysm growth >0.4 cm per year
Measured: 1 year
Secondary outcomes (4)
Number of clinical events
death, aortic rupture, aneurysm growth >0.4 cm per year, surgical or endovascular repair
Measured: 1 year
Change in CT parameter of aneurysm
diameter
Measured: 1 year
Change in CT parameter of aneurysm
volume
Measured: 1 year
Change in CT parameter of aneurysm
wall shear stress
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2020
- Study start3 Apr 2020
- Primary completion17 Apr 2023
- Study completion17 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic Aneurysm (AAA)Studies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 323 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04333641
- Sponsor's protocol ID
- 4-2019-0443
- Status last verified
- Mar 2024
- First submitted
- 31 Mar 2020
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Novel Imaging Markers Predicting the Progression of Abdominal Aortic Aneurysm Using 3D Computed Tomography
- ClinicalTrials.gov ID
- NCT04333641
- Acronym / sponsor ID
- 4-2019-0443
- Conditions
- Abdominal Aortic Aneurysm (AAA)
- Keywords
- abdominal Aortic Aneurysm, CT, risk factor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 323 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 3 Apr 2020 (actual)
- Primary completion
- 17 Apr 2023 (actual)
- Study completion
- 17 Apr 2023 (actual)
- First posted
- 3 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Prospective single-arm multicenter registry
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| small AAA patients | – | –all patients with small AAA |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with small abdominal aortic aneurysm with maximal aneurysm of 30 ~50 mm
Key inclusion criteria (1 listed)
- abdominal aortic aneurysm with maximum diameter of 30-50 mm
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Major adverse aorta-related events
Time frame: 1 year
Composite event of death, aortic rupture, or aneurysm growth >0.4 cm per year
4 secondary outcomes
Number of clinical events
Time frame: 1 year
Change in CT parameter of aneurysm
Time frame: 1 year
Change in CT parameter of aneurysm
Time frame: 1 year
Change in CT parameter of aneurysm
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Aortic Aneurysm (AAA), run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse aorta-related events (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024.