Abdominal Aortic AneurysmNCT00740740
Biomarkers of Aneurysm Wall Strength
An observational study of Abdominal Aortic Aneurysm, run by Radboud University Medical Center at 2 sites in Netherlands.
Trial summary
The purpose of this study is to identify possible in vivo biochemical and biological markers related to aortic wall strength. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm
- How many people
- 50 participants
- Where
- 2 sitesNetherlands
- Study dates
- Jun 2007to Jan 2010
- 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: Tertiary care clinic. Patients scheduled for transbadominal aortic surgery
Who may be able to join
- Patient scheduled for transabdominal aortic surgery
Who cannot join
- Patient characteristics and aneurysm anatomy suitable for endovascular repair
- Previous aortic surgery
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites, 2 recruiting
- Recruiting
Alysis Zorggroep, Rijnstate Hospital
Arnhem, Gelderland, 6815AD
Steven Sterkenburg, MD, 0031-88-005 8888, SvanSterkenburg@alysis.nl
Steven Sterkenburg, MD
- Recruiting
Radboud University Nijmegen Medical Center
Nijmegen, Gelderland, 6525GA
Maarten Truijers, MD, 0031-24-3615333, m.truijers@chir.umcn.nl
Maarten Truijers, MD
About this study
Official title: Biological and Biochemical Markers of Aneurysm Wall Degradation; Towards Non-Invasive Wall Strength Analysis.
The purpose of this study is to identify possible in vivo biochemical and biological markers related to aortic wall strength.
Read the detailed description
Rupture of an Abdominal Aortic Aneurysm (AAA) is potentially lethal. prophylactic surgical repair is therefore warranted when the risk of rupture exceeds the risk of complications following surgery. Aneurysm rupture occurs when the forces (stress) acting on the aneurysm wall surpass aneurysm wall strength. Information on both wall stress and strength might therefore improve rupture risk assessment and patient selection for prophylactic repair. Although aneurysm wall stress calculations are possible, no in vivo method exists to determine aneurysm wall strength. This study was designed to identify possible biomarkers of aneurysm wall strength
- Conditions
- Abdominal Aortic Aneurysm
- Keywords
- Aneurysm, Rupture
- Medical subject headings
- Aortic Aneurysm, Abdominal, Aneurysm, Rupture
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 |
|---|---|---|
| 1 | Patients scheduled for elective conventional aneurysm repair | |
| 2 | Patients scheduled for emergent conventional aneurysm repair | |
| 3 | Patients scheduled for aortic bypass surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aneurysm wall strength
Measured: Post-operative
Secondary outcomes (4)
Extra Cellular Matrix components (Glucoaminoglycans)
Measured: post-operative
Biochemical blood analysis
Measured: post-operative
MMP content
Measured: post-operative
Degree of inflammation
Measured: Post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2008 (estimated)
- Study startJun 2007
- Primary completionJan 2010 (estimated)
- Study completionJan 2010 (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 Radboud University Medical CenterThe 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-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Jan Blankensteijn, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00740740
- Sponsor's protocol ID
- Wallstrength_01
- Status last verified
- Aug 2008
- First submitted
- 22 Aug 2008
- Last updated
- 25 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological and Biochemical Markers of Aneurysm Wall Degradation; Towards Non-Invasive Wall Strength Analysis.
- ClinicalTrials.gov ID
- NCT00740740
- Acronym / sponsor ID
- Wallstrength_01
- Conditions
- Abdominal Aortic Aneurysm
- Keywords
- Aneurysm, Rupture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Jan 2010 (estimated)
- Study completion
- Jan 2010 (estimated)
- First posted
- 25 Aug 2008 (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.
The purpose of this study is to identify possible in vivo biochemical and biological markers related to aortic wall strength.
Detailed description
Rupture of an Abdominal Aortic Aneurysm (AAA) is potentially lethal. prophylactic surgical repair is therefore warranted when the risk of rupture exceeds the risk of complications following surgery. Aneurysm rupture occurs when the forces (stress) acting on the aneurysm wall surpass aneurysm wall strength. Information on both wall stress and strength might therefore improve rupture risk assessment and patient selection for prophylactic repair. Although aneurysm wall stress calculations are possible, no in vivo method exists to determine aneurysm wall strength. This study was designed to identify possible biomarkers of aneurysm wall strength
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients scheduled for elective conventional aneurysm repair |
| 2 | – | –Patients scheduled for emergent conventional aneurysm repair |
| 3 | – | –Patients scheduled for aortic bypass surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Tertiary care clinic. Patients scheduled for transbadominal aortic surgery
Key inclusion criteria (1 listed)
- Patient scheduled for transabdominal aortic surgery
Key exclusion criteria (2 listed)
- Patient characteristics and aneurysm anatomy suitable for endovascular repair
- Previous aortic surgery
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
Aneurysm wall strength
Time frame: Post-operative
4 secondary outcomes
Extra Cellular Matrix components (Glucoaminoglycans)
Time frame: post-operative
Biochemical blood analysis
Time frame: post-operative
MMP content
Time frame: post-operative
Degree of inflammation
Time frame: Post-operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2008.
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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.
Jan Blankensteijn principal investigator
Radboud University Medical Center
2 sites 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 Radboud University Medical Center at 2 sites in Netherlands.
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 2 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: status not confirmed, as of the sponsor's last update on 25 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maarten Truijers, MD (0031-24-3615333, M.Truijers@chir.umcn.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aneurysm wall strength (time frame: Post-operative). 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 25 Aug 2008.