The association between the 5-LipOxygenase pathway and abdominal aortic aneurysms

ISRCTN	ISRCTN03932642
DOI	https://doi.org/10.1186/ISRCTN03932642
Secondary identifying numbers	NL770, NTR781

Submission date: 28/12/2006
Registration date: 28/12/2006
Last edited: 14/01/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr L N Broekhuizen
Scientific

Academic Medical Center (AMC) Amsterdam
Department of Vascular Medicine, F4-142
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Email	L.N.Broekhuizen@amc.uva.nl

Study information

Study design	Non-randomised controlled trial
Primary study design	Interventional
Secondary study design	Non randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	The association between the 5-LipOxygenase pathway and abdominal aortic aneurysms
Study acronym	5-LO pathway
Study objectives	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(s)	The study has been approved by the medical ethics commission of the Academic Medical Centre on November 2, 2006 (ref: MEC 06/240).
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/11/2006
Completion date	01/11/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target number of participants	200
Key inclusion criteria	1. Presence of asymptomatic, small AAA 2. Older than 20 years 3. Male or female
Key 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
Date of first enrolment	01/11/2006
Date of final enrolment	01/11/2009

Locations

Countries of recruitment

Netherlands

Study participating centre

Academic Medical Center (AMC) Amsterdam

Amsterdam
1100 DD
Netherlands

Sponsor information

Academic Medical Center (AMC) (The Netherlands)
Hospital/treatment centre

Department of Vascular Medicine
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Website	http://www.amc.uva.nl/#http://www.amc.uva.nl/
"ROR"	https://ror.org/03t4gr691

Funders

Funder type

Other

This study was funded by the principal investigator of this trial, and received no external funding.

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	genetic analysis results	01/02/2012	14/01/2021	Yes	No

Editorial Notes

14/01/2021: The following changes have been made:
1. Publication reference added.
2. The NTR numbers have been added.