Abdominal Aortic AneurysmAAA-angioCTNCT02875444
Measurement of Maximum Diameter of Native Abdominal Aortic Aneurysm by Angio-CT
An observational study of Abdominal Aortic Aneurysm, run by CHU de Reims at 1 site in France.
Trial summary
Screening for an abdominal aortic aneurysm, monitoring its growth and evaluation of its risk of rupture are based on the measure of its maximum diameter. The abdominal aortic aneurysm's treatment to prevent its rupture is recommended from a threshold of 50-55 mm in men and of 45-50 mm in women. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm
- What is being tested?
- Angio-CT
- How many people
- 46 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2013to Dec 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with non-opered abdominal aortic aneurysm with angio-CT realized between 01/01 2010 au 04/15/2012
Who may be able to join
- patients with abdominal aortic aneurysm
Who cannot join
- inflammatory aneurysm
- false aneurysm
- aneurysm after open repair or stent graft
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Measurement of Maximum Diameter of Native Abdominal Aortic Aneurysm by Angio-computed Tomography
Screening for an abdominal aortic aneurysm, monitoring its growth and evaluation of its risk of rupture are based on the measure of its maximum diameter. The abdominal aortic aneurysm's treatment to prevent its rupture is recommended from a threshold of 50-55 mm in men and of 45-50 mm in women.
The importance of this measure for patient management justify a specific and homogeneous protocol of measure. However, the diversity of methods of measuring the maximum diameter with scanner and ultrasound was shown.
The impact of various angio-CT based measures of maximum AAA diameter, and the impact of reproducibility limits on the decision to operate have never been investigated.
Read the detailed description
The aims of the study were :
Analyze the consequences on clinical decisions of this wide choice of methodologies for measurement of abdominal aortic aneurysm maximum diameter when using angio-CT; Identify the method of measurement that yields the best agreement for patient management.
- Conditions
- Abdominal Aortic Aneurysm
- Being tested
- Angio-CT
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angio-CTOther
| Study group | Role | What they receive |
|---|---|---|
| group "abdominal aortic aneurysm" | Patients with non-operated abdominal aortic aneurysm with angio-CT realized between 01/01 2010 au 04/15/2012 Receives: Other: Angio-CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum diameter of abdominal aortic aneurysm
Maximum abdominal aortic aneurysm measured using 11 measurement methods
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2016 (estimated)
- Study startJan 2013
- Primary completionMay 2013
- Study completionDec 2013
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 CHU de ReimsThe 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
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02875444
- Sponsor's protocol ID
- 2015Ao001
- Acronym
- AAA-angioCT
- Status last verified
- Sep 2016
- First submitted
- 18 Aug 2016
- Last updated
- 7 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Maximum Diameter of Native Abdominal Aortic Aneurysm by Angio-computed Tomography
- ClinicalTrials.gov ID
- NCT02875444
- Acronym / sponsor ID
- AAA-angioCT / 2015Ao001
- Conditions
- Abdominal Aortic Aneurysm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- May 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 23 Aug 2016 (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.
Screening for an abdominal aortic aneurysm, monitoring its growth and evaluation of its risk of rupture are based on the measure of its maximum diameter. The abdominal aortic aneurysm's treatment to prevent its rupture is recommended from a threshold of 50-55 mm in men and of 45-50 mm in women.
The importance of this measure for patient management justify a specific and homogeneous protocol of measure. However, the diversity of methods of measuring the maximum diameter with scanner and ultrasound was shown.
The impact of various angio-CT based measures of maximum AAA diameter, and the impact of reproducibility limits on the decision to operate have never been investigated.
Detailed description
The aims of the study were :
Analyze the consequences on clinical decisions of this wide choice of methodologies for measurement of abdominal aortic aneurysm maximum diameter when using angio-CT; Identify the method of measurement that yields the best agreement for patient management.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| group "abdominal aortic aneurysm" | – | Other: Angio-CTPatients with non-operated abdominal aortic aneurysm with angio-CT realized between 01/01 2010 au 04/15/2012 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with non-opered abdominal aortic aneurysm with angio-CT realized between 01/01 2010 au 04/15/2012
Key inclusion criteria (1 listed)
- patients with abdominal aortic aneurysm
Key exclusion criteria (3 listed)
- inflammatory aneurysm
- false aneurysm
- aneurysm after open repair or stent graft
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Angio-CT | Other | group "abdominal aortic aneurysm" |
Primary outcome
Maximum diameter of abdominal aortic aneurysm
Time frame: Day 0
Maximum abdominal aortic aneurysm measured using 11 measurement methods
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Aneurysm, run by CHU de Reims 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 7 Sep 2016. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum diameter of abdominal aortic aneurysm (time frame: Day 0). 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 7 Sep 2016.