Contact information
Type
Scientific
Primary contact
Dr L N Broekhuizen
ORCID ID
Contact details
Academic Medical Center (AMC) Amsterdam
Department of Vascular Medicine
F4-142
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
L.N.Broekhuizen@amc.uva.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1
Study information
Scientific title
Acronym
5-LO pathway
Study hypothesis
Rationale: Accumulating evidence suggests that increased generation of LeukoTrienes (LT) by the 5-LipOxygenase (5-LO) pathway may have direct actions on the vessel wall, particularly the adventitia, in the evolution of Abdominal Aortic Aneurysm (AAA). Augmented inflammatory activity may further weaken the arterial wall, which may result in rapid expansion of the AAA and ultimately rupture. Thus, circulating and/or urinary levels of LT may serve as a novel biomarker for monitoring small asymptomatic AAA and may be an useful predictor of aneurysmal expansion.
We hypothesise that:
1. LTs produced by the 5-LO pathway are adversely implicated in the progression of AAA, and
2. Certain 5-LO pathway associated haplotypes (e.g. spanning the LT4h gene or FLAP) may be associated with rapid expansion of AAA.
Ethics approval
The study has been approved by the medical ethics commission of the Academic Medical Centre on November 2, 2006 (ref: MEC 06/240).
Study design
Non-randomised controlled trial
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Abdominal aneurysm of the aorta
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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.
Secondary outcome measures
The relation between other inflammatory markers (e.g. MMP9, hsCRP, MIP-1a, RANTES, MCP-1, CD-40L) and rates of expansion of small AAAs.
Overall trial start date
01/11/2006
Overall trial end date
01/11/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Presence of asymptomatic, small AAA
2. Older than 20 years
3. Male or female
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
200
Participant 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
Recruitment start date
01/11/2006
Recruitment end date
01/11/2009
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Medical Center (AMC) Amsterdam
Amsterdam
1100 DD
Netherlands
Sponsor information
Organisation
Academic Medical Center (AMC) (The Netherlands)
Sponsor details
Department of Vascular Medicine
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Other
Funder name
This study was funded by the principal investigator of this trial, and received no external funding.
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary