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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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25 January 2021 |
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Main ID: |
ISRCTN03932642 |
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Date of registration:
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28/12/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The association between the 5-LipOxygenase pathway and abdominal aortic aneurysms
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Scientific title:
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The association between the 5-LipOxygenase pathway and abdominal aortic aneurysms |
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Date of first enrolment:
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01/11/2006 |
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Target sample size:
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200 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN03932642 |
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Study type:
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Interventional |
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Study design:
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Non-randomised controlled trial (Treatment)
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Phase:
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Not Specified
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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L N
Broekhuizen |
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Address:
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Academic Medical Center (AMC) Amsterdam
Department of Vascular Medicine, F4-142
P.O. Box 22660
1100 DD
Amsterdam
Netherlands |
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Telephone:
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Email:
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L.N.Broekhuizen@amc.uva.nl |
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Affiliation:
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Name:
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Address:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Presence of asymptomatic, small AAA
2. Older than 20 years
3. Male or female
Exclusion criteria:
1. A clinical condition which is actual and may interfere with the endpoints of the study (e.g. malignancy, infection/sepsis, chronic inflammatory disease )
2. The use of drugs with anti-inflammatory properties including prostaglandin synthetase inhibitors, which have been shown to reduce the inflammatory response
3. The use of immunosuppressants, including glucocorticoids, e.g., cyclosporine
4. Ruptured/symptomatic AAAs
Age minimum:
Age maximum:
Gender:
Not Specified
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Health Condition(s) or Problem(s) studied
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Abdominal aneurysm of the aorta
Circulatory System
Circulatory diseases
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Intervention(s)
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Patients with an asymptomatic, small aneurysm of the abdominal aorta and healthy male volunteers will visit the hospital four times during two years, at an interval of six months. During the first visit, patients will undergo a short physical examination, blood sampling, and ultrasound scanning for measurement of the maximum anterior-posterior diameter of the abdominal aorta.
During the follow up visits patients will be subjected only to ultrasound scanning. Except for blood sampling related inconvenience (e.g., hematomas) there are no risks associated with participation. In addition, there are no direct benefits for subjects participating in this study.
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Primary Outcome(s)
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1. The relation between LT levels (in stimulated neutrophils and urine) and annual rate of expansion of small AAAs.
2. Comparison of LT levels between subjects with AAA and normal controls.
3. The association between at-risk gene variant genes involved in 5-LO pathway and AAA growth rate.
4. To assess the presence of neutrophils and 5-LO products in AAA specimens.
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Secondary Outcome(s)
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The relation between other inflammatory markers (e.g. MMP9, hsCRP, MIP-1a, RANTES, MCP-1, CD-40L) and rates of expansion of small AAAs.
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Secondary ID(s)
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NL770, NTR781
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Source(s) of Monetary Support
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This study was funded by the principal investigator of this trial, and received no external funding.
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Ethics review
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Status:
Approval date:
Contact:
The study has been approved by the medical ethics commission of the Academic Medical Centre on November 2, 2006 (ref: MEC 06/240).
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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01/11/2009 |
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URL:
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