Abdominal Aortic AneurysmsNCT00546013
Abdominal Aortic Aneurysms and Pseudoexfoliation Syndrome
An observational study of Abdominal Aortic Aneurysms and Pseudoexfoliation Syndrome, run by European Georges Pompidou Hospital at 1 site in France.
Trial summary
Conflicting results have been reported concerning the association of pseudoexfoliation syndrome (PXF) and abdominal aortic aneurysms (AAA). Schumacher et al. reported an association between AAA and PXF, with no consideration of grade. However, a later study did not confirm the association between AAA and PXF. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysms, Pseudoexfoliation Syndrome, Hypertension
- How many people
- 208 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2001to Jul 2002
- Phase
- Observational
- Are there results?
- None posted in the registry
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: in patients suffering from abdominal aortic aneurism as part of a routine clinical yearly follow-up and hypertensive patients without abdominal aortic aneurism and that were more than 60 years old to have similar mean ages in both groups, as pseudoexfoliation and abdominal aortic aneurism are age-related disorders
Who may be able to join
- Presence of abdominal aortic aneurism
- Systemic hypertension without abdominal aortic aneurism over 60 years old
Who cannot join
- Unknown status for abdominal aortic aneurism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Abdominal Aortic Aneurysms Are Associated With Pseudoexfoliation Syndrome
Conflicting results have been reported concerning the association of pseudoexfoliation syndrome (PXF) and abdominal aortic aneurysms (AAA). Schumacher et al. reported an association between AAA and PXF, with no consideration of grade. However, a later study did not confirm the association between AAA and PXF. The present study aimed at comparing the relative prevalence of PXF in patients suffering from AAA and in age-matched hypertensive patients.
- Keywords
- abdominal aortic aneurysms, pseudoexfoliation syndrome, glaucoma
- Medical subject headings
- Aortic Aneurysm, Abdominal, Exfoliation Syndrome, Hypertension, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| AAA group, control group | AAA group : with AAA Control group: without AAA |
What is being measured
The primary outcome is the main question the study is designed to answer.
standard ophthalmologic examination to group patients according to their pseudoexfoliation status
Measured: Day of standard ophthalmologic examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2007 (estimated)
- Study startDec 2001
- Study completionJul 2002
Why it stopped: all patients required included
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic AneurysmsStudies of the same condition, open and under way.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Georges Pompidou Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Patrick Rossignol, MD, PhD, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00546013
- Sponsor's protocol ID
- 01
- Status last verified
- Oct 2007
- First submitted
- 17 Oct 2007
- Last updated
- 18 Oct 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abdominal Aortic Aneurysms Are Associated With Pseudoexfoliation Syndrome
- ClinicalTrials.gov ID
- NCT00546013
- Acronym / sponsor ID
- 01
- Keywords
- abdominal aortic aneurysms, pseudoexfoliation syndrome, glaucoma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: all patients required included
- Enrolment
- 208 participants (actual)
- Lead sponsor
- European Georges Pompidou HospitalUniversity, hospital or other
- Study start
- Dec 2001
- Study completion
- Jul 2002 (actual)
- First posted
- 18 Oct 2007 (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.
Conflicting results have been reported concerning the association of pseudoexfoliation syndrome (PXF) and abdominal aortic aneurysms (AAA). Schumacher et al. reported an association between AAA and PXF, with no consideration of grade. However, a later study did not confirm the association between AAA and PXF. The present study aimed at comparing the relative prevalence of PXF in patients suffering from AAA and in age-matched hypertensive patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AAA group, control group | – | –AAA group : with AAA Control group: without AAA |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- in patients suffering from abdominal aortic aneurism as part of a routine clinical yearly follow-up and hypertensive patients without abdominal aortic aneurism and that were more than 60 years old to have similar mean ages in both groups, as pseudoexfoliation and abdominal aortic aneurism are age-related disorders
Key inclusion criteria (2 listed)
- Presence of abdominal aortic aneurism
- Systemic hypertension without abdominal aortic aneurism over 60 years old
Key exclusion criteria (1 listed)
- Unknown status for abdominal aortic aneurism
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
standard ophthalmologic examination to group patients according to their pseudoexfoliation status
Time frame: Day of standard ophthalmologic examination
Results and safety
The study was stopped early (reason given: all patients required included). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2007.
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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. This study is not recruiting at the moment.
Patrick Rossignol, MD, PhD study director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Aortic Aneurysms and Pseudoexfoliation Syndrome, run by European Georges Pompidou Hospital at 1 site in France.
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 2 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: stopped early, as of the sponsor's last update on 18 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was stopped early (reason given: all patients required included). Results are not available in the source record.
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?
standard ophthalmologic examination to group patients according to their pseudoexfoliation status (time frame: Day of standard ophthalmologic examination). 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 18 Oct 2007.