Aortic Aneurysm, AbdominalNCT01205945
The Effect of Abdominal Aortic Aneurysm Screening on Mortality in Asian Population
An observational study of Aortic Aneurysm, Abdominal, run by Kyunghee University Medical Center at 1 site in South Korea.
Trial summary
Abdominal aortic aneurysm(AAA) occurs when the infrarenal aorta expands to a maximal diameter of 3.0cm or greater. Although AAA may asymptomatic for many years, almost one third eventually rupture if left untreated. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Aortic Aneurysm, Abdominal
- How many people
- 12,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2010to Aug 2017
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Popultaion who reside in Korea as an Asian
Who may be able to join
- all men aged 60 to 85 years
- women aged 60 to 85 years with cardiovascular risk factors such as hypertension, hyperlipidemia, peripheral arterial occlusive disease, coronary artery disease, cerebrovascular attack.
- men and women older than 50 years with a family history of AAA
Who cannot join
- people who was diagnosed with AAA
- people who underwent aneurysm repair such as open aneurysm repair or endovascular aneurysm repair
- People who underwent abdominal aortic surgery such as aortobifemoral bypass
- People whose life expectancy is less than 2 years
- People who appear unfit for repair of AAA
- people who do not agree with this study
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Vascular Surgery, Kyung Hee University East-West Neo Medical Center
Seoul, 132-727
Jin Hyun Joh, MD, PhD, 82-2-440-6261, jhjoh@khu.ac.kr
About this study
Official title: The Effect of Abdominal Aortic Aneurysm Screening on Mortality in Asian: A Randomized, Controlled Trial
Abdominal aortic aneurysm(AAA) occurs when the infrarenal aorta expands to a maximal diameter of 3.0cm or greater. Although AAA may asymptomatic for many years, almost one third eventually rupture if left untreated.
Several randomized trials showed that ultrasonographic screening for AAA could reduce the frequency of acute operations and AAA-related mortality.
However, all of randomized trials were performed in Western countries. There was no randomized trials for AAA screening in Asian countries.
This randomized, controlled trial is to analyze the benefits of screening old population for AAA in Korea.
Read the detailed description
Old population, aged from 60 to 85 years, are randomized into two groups; one group is invited for ultrasonographic screening for AAA, and the other acts as age- and sex-matched controls.
For screening group, The anterioposterior and transverse diameter of the infrarenal aorta is measured at their maximal sizes. The subsequent surveillance of screened patients is done as follows
- Aortic diameter less than 3.0cm, no further testing
- AAA 3 to 4cm, ultrasonographic follow-up every year
- AAA 4 to 5cm, ultrasonographic follow-up every 6 months
- AAA greater than 5cm, referral to a vascular surgeon
For control group, the information for any causes of death is collected every year.
- Conditions
- Aortic Aneurysm, Abdominal
- Keywords
- Aortic aneurysm, abdominal, Screening, Mortality
- Medical subject headings
- Aortic Aneurysm, Abdominal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2010 (estimated)
- Study startAug 2010
- Primary completionAug 2012 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Aneurysm, AbdominalStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyunghee University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Jin Hyun Joh, MD, PhD, Principal investigator, East West Neo Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01205945
- Sponsor's protocol ID
- KHNMC IRB 2010-019
- Status last verified
- Sep 2010
- First submitted
- 20 Sep 2010
- Last updated
- 21 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Abdominal Aortic Aneurysm Screening on Mortality in Asian: A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT01205945
- Acronym / sponsor ID
- KHNMC IRB 2010-019
- Conditions
- Aortic Aneurysm, Abdominal
- Keywords
- Aortic aneurysm, abdominal, Screening, Mortality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12,000 participants (estimated)
- Lead sponsor
- Kyunghee University Medical CenterUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 21 Sep 2010 (estimated)
- 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.
Abdominal aortic aneurysm(AAA) occurs when the infrarenal aorta expands to a maximal diameter of 3.0cm or greater. Although AAA may asymptomatic for many years, almost one third eventually rupture if left untreated.
Several randomized trials showed that ultrasonographic screening for AAA could reduce the frequency of acute operations and AAA-related mortality.
However, all of randomized trials were performed in Western countries. There was no randomized trials for AAA screening in Asian countries.
This randomized, controlled trial is to analyze the benefits of screening old population for AAA in Korea.
Detailed description
Old population, aged from 60 to 85 years, are randomized into two groups; one group is invited for ultrasonographic screening for AAA, and the other acts as age- and sex-matched controls.
For screening group, The anterioposterior and transverse diameter of the infrarenal aorta is measured at their maximal sizes. The subsequent surveillance of screened patients is done as follows
- Aortic diameter less than 3.0cm, no further testing
- AAA 3 to 4cm, ultrasonographic follow-up every year
- AAA 4 to 5cm, ultrasonographic follow-up every 6 months
- AAA greater than 5cm, referral to a vascular surgeon
For control group, the information for any causes of death is collected every year.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Popultaion who reside in Korea as an Asian
Key inclusion criteria (3 listed)
- all men aged 60 to 85 years
- women aged 60 to 85 years with cardiovascular risk factors such as hypertension, hyperlipidemia, peripheral arterial occlusive disease, coronary artery disease, cerebrovascular attack.
- men and women older than 50 years with a family history of AAA
Key exclusion criteria (6 listed)
- people who was diagnosed with AAA
- people who underwent aneurysm repair such as open aneurysm repair or endovascular aneurysm repair
- People who underwent abdominal aortic surgery such as aortobifemoral bypass
- People whose life expectancy is less than 2 years
- People who appear unfit for repair of AAA
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2010.
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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.
Jin Hyun Joh, MD, PhD principal investigator
East West Neo Medical Center
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 Aortic Aneurysm, Abdominal, run by Kyunghee University Medical Center 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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 21 Sep 2010. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jin Hyun Joh, MD, PhD (82-2-440-6261, jhjoh@khu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 21 Sep 2010.