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

Aortic Aneurysm, Abdominal Clinical Trial

Official title:

The Effect of Abdominal Aortic Aneurysm Screening on Mortality in Asian: A Randomized, Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01205945
• Other study ID #: KHNMC IRB 2010-019
• Status: Recruiting
• Phase: N/A
• First received: September 20, 2010
• Last updated: September 20, 2010
• Start date: August 2010
• Est. completion date: August 2017

Study information

• Verified date: September 2010
• Source: Kyunghee University Medical Center
• Contact: Jin Hyun Joh, MD, PhD
• Phone: 82-2-440-6261
• Email: jhjoh[@]khu.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12000
• Est. completion date: August 2017
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Locations

Country	Name	City	State
Korea, Republic of	Vascular Surgery, Kyung Hee University East-West Neo Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Kyunghee University Medical Center

Country where clinical trial is conducted

Korea, Republic of,