Condition category
Circulatory System
Date applied
28/12/2006
Date assigned
28/12/2006
Last edited
15/01/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.amc.uva.nl/#http://www.amc.uva.nl/

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

Publication citations

Additional files

Editorial Notes