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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2010 by Kyunghee University Medical Center
Sponsor:
Information provided by:
Kyunghee University Medical Center
ClinicalTrials.gov Identifier:
NCT01205945
First received: September 20, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by Kyunghee University Medical Center:

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)
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.

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Popultaion who reside in Korea as an Asian

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01205945

Contacts
Contact: Jin Hyun Joh, MD, PhD 82-2-440-6261 jhjoh@khu.ac.kr

Locations
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   
Sponsors and Collaborators
Kyunghee University Medical Center
Investigators
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
Aortic Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014