The Effect of Abdominal Aortic Aneurysm Screening on Mortality in Asian Population
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Purpose
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.
| Condition |
|---|
|
Aortic Aneurysm, Abdominal |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | The Effect of Abdominal Aortic Aneurysm Screening on Mortality in Asian: A Randomized, Controlled Trial |
| Estimated Enrollment: | 12000 |
| Study Start Date: | August 2010 |
| Estimated Study Completion Date: | August 2017 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 50 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Popultaion who reside in Korea as an Asian
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations| Contact: Jin Hyun Joh, MD, PhD | 82-2-440-6261 | jhjoh@khu.ac.kr |
| Korea, Republic of | |
| Vascular Surgery, Kyung Hee University East-West Neo Medical Center | Recruiting |
| Seoul, Korea, Republic of, 132-727 | |
| Contact: Jin Hyun Joh, MD, PhD 82-2-440-6261 jhjoh@khu.ac.kr | |
| Principal Investigator: | Jin Hyun Joh, MD, PhD | East West Neo Medical Center |
More Information
No publications provided
| Responsible Party: | Jin Hyun Joh, Kyung Hee University East-West Neo Medical Center |
| ClinicalTrials.gov Identifier: | NCT01205945 History of Changes |
| Other Study ID Numbers: | KHNMC IRB 2010-019 |
| Study First Received: | September 20, 2010 |
| Last Updated: | September 20, 2010 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Kyunghee University Medical Center:
|
Aortic aneurysm, abdominal Screening Mortality |
Additional relevant MeSH terms:
|
Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal |
Vascular Diseases Cardiovascular Diseases Aortic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013