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
Scientific
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 |
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
1100 DD
Netherlands
Sponsor information
Academic Medical Center (AMC) (The Netherlands)
Hospital/treatment centre
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.
