Viewing Study NCT01205945



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Study NCT ID: NCT01205945
Status: UNKNOWN
Last Update Posted: 2010-09-21
First Post: 2010-09-20

Brief Title: The Effect of Abdominal Aortic Aneurysm Screening on Mortality in Asian Population
Sponsor: Kyunghee University Medical Center
Organization: Kyunghee University Medical Center

Study Overview

Official Title: The Effect of Abdominal Aortic Aneurysm Screening on Mortality in Asian A Randomized Controlled Trial
Status: UNKNOWN
Status Verified Date: 2010-09
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Abdominal aortic aneurysmAAA occurs when the infrarenal aorta expands to a maximal diameter of 30cm 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 30cm 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None