Abdominal Aortic AneurysmAAAscreeningNCT01248533
Screening for Abdominal Aortic Aneurysm in 65 Year Old Males in Oslo
An observational study of Abdominal Aortic Aneurysm, run by Oslo University Hospital.
Trial summary
Male subjects, 65 years of age, living in Oslo, Norway will be invited to be screened for abdominal aortic aneurysm. Read more about this study
- Who is it for?
- Ages 65 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Abdominal Aortic Aneurysm
- How many people
- 7,500 participants
- Where
- No sites listed yet
- Study dates
- May 2011to Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 65 years
- Men only
- Healthy volunteers accepted
- Older adult
Study population: 65 year old males in Oslo
Who may be able to join
- Males aged 65 years
Who cannot join
- None
About this study
Official title: 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.
Read the 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.
- Conditions
- Abdominal Aortic Aneurysm
- Keywords
- Abdominal aortic aneurysm, atherosclerosis
- Medical subject headings
- Aortic Aneurysm, Abdominal, Atherosclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal Aortic Aneurysm (AAA)
AAA definition: diameter equal or more than 30 mm. The number of identified patients with AAA will be yearlig assessed.
Measured: Yearly the number of patients with AAA among the screened population will be assessed during the inclusion period of 18 years..
Secondary outcomes (1)
Peripheral Arterial Disease (PAD)
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.
Measured: Yearly the number of patients with PAD among the screened poplulation will be assessed during the inclusion period of 18 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2010 (estimated)
- Study startMay 2011
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 7,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jorgen J Jorgensen, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01248533
- Sponsor's protocol ID
- 2009/866
- Acronym
- AAAscreening
- Status last verified
- Mar 2016
- First submitted
- 11 Nov 2010
- Last updated
- 30 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: All data are entered into the Electronic Patient Journal of Oslo University Hospital (DIPS)
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Abdominal Aortic Aneurysm
- ClinicalTrials.gov ID
- NCT01248533
- Acronym / sponsor ID
- AAAscreening / 2009/866
- Conditions
- Abdominal Aortic Aneurysm
- Keywords
- Abdominal aortic aneurysm, atherosclerosis
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 7,500 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 25 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Male subjects, 65 years of age, living in Oslo, Norway will be invited to be screened for abdominal aortic aneurysm.
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 design
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- 65 year old males in Oslo
Key inclusion criteria (1 listed)
- Males aged 65 years
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2016.
- Individual participant dataSharing planned: Yes. All data are entered into the Electronic Patient Journal of Oslo University Hospital (DIPS)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Aortic Aneurysm, run by Oslo University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 30 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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..). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2016.