The Effect of Abdominal Aortic Aneurysm Screening on Mortality in Asian Population

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.

Study Overview

• Status: Unknown
• Conditions: Aortic Aneurysm, Abdominal

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 Type: Observational
• Enrollment (Anticipated): 12000

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 132-727
    • Recruiting
    • Vascular Surgery, Kyung Hee University East-West Neo Medical Center
    • Contact: Jin Hyun Joh, MD, PhD; Phone Number: 82-2-440-6261; Email: jhjoh@khu.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Popultaion who reside in Korea as an Asian

Description

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

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Kyunghee University Medical Center
• Investigators: Principal Investigator: Jin Hyun Joh, MD, PhD, East West Neo Medical Center

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Anticipated): August 1, 2012
• Study Completion (Anticipated): August 1, 2017

Study Registration Dates

• First Submitted: September 20, 2010
• First Submitted That Met QC Criteria: September 20, 2010
• First Posted (Estimate): September 21, 2010

Study Record Updates

• Last Update Posted (Estimate): September 21, 2010
• Last Update Submitted That Met QC Criteria: September 20, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: Screening; Mortality; Aortic aneurysm, abdominal
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: KHNMC IRB 2010-019