- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01248533
Screening for Abdominal Aortic Aneurysm in 65 Year Old Males in Oslo (AAAscreening)
March 29, 2016 updated by: Jorgen J Jorgensen, Oslo University Hospital
Screening for Abdominal Aortic Aneurysm
Male subjects, 65 years of age, living in Oslo, Norway will be invited to be screened for abdominal aortic aneurysm.
Study Overview
Status
Enrolling by invitation
Conditions
Detailed Description
The invited population will be offered ultrasound investigation of their abdominal aorta.
Further information regarding risk factors will be noted and measurement of ankle-brachial index will be measured/calculated.
A further step in the future will be to sample blood with focus on different cytokines and genmediators.
Study Type
Observational
Enrollment (Actual)
7500
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 65 years (Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Sampling Method
Probability Sample
Study Population
65 year old males in Oslo
Description
Inclusion Criteria:
- Males aged 65 years
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Abdominal Aortic Aneurysm (AAA)
Time Frame: Yearly the number of patients with AAA among the screened population will be assessed during the inclusion period of 18 years..
|
AAA definition: diameter equal or more than 30 mm.
The number of identified patients with AAA will be yearlig assessed.
|
Yearly the number of patients with AAA among the screened population will be assessed during the inclusion period of 18 years..
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Peripheral Arterial Disease (PAD)
Time Frame: Yearly the number of patients with PAD among the screened poplulation will be assessed during the inclusion period of 18 years.
|
Investigate the prevalence of PAD among patients with AAA defined as having Ankle-Arm Index (AAI) less than 0.9.
The number of these patients will be assessed yearly.
|
Yearly the number of patients with PAD among the screened poplulation will be assessed during the inclusion period of 18 years.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2011
Primary Completion (Anticipated)
December 1, 2029
Study Completion (Anticipated)
December 1, 2029
Study Registration Dates
First Submitted
November 11, 2010
First Submitted That Met QC Criteria
November 24, 2010
First Posted (Estimate)
November 25, 2010
Study Record Updates
Last Update Posted (Estimate)
March 30, 2016
Last Update Submitted That Met QC Criteria
March 29, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2009/866
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
All data are entered into the Electronic Patient Journal of Oslo University Hospital (DIPS)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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