No registrations found.
ID
Source
Brief title
Health condition
Abdominal Aortic Aneurysm
Sponsors and support
Intervention
Outcome measures
Primary outcome
Aortic wall IL6, IL8 and MCP-1 levels.
Secondary outcome
1. Aortic wall cell counts;
2. Aortic wall protease expression;
3. Aortic wall transcription factor activation.
Background summary
N/A
Study objective
Independently of their lipid lowering effects statins have been shown to quench markers of vascular inflammation. In an observational study we observed a mild but dose dependent anti -inflammatory effect of intermediate dose statins on vascular inflammation. As of these observations we now propose to test the hypothesis that high dose statins have a clinically relevant effect on vascular inflammation in the abdominal aortic aneurysm.
Study design
Minimal treatment period 2 weeks prior to the surgery.
Intervention
Simvastatin 80 mg OID.
Dpt. of Vascular Surgery.<br>
PO-box 9600
Jan H. Lindeman
Leiden 2300 RC
The Netherlands
Lindeman@lumc.nl
Dpt. of Vascular Surgery.<br>
PO-box 9600
Jan H. Lindeman
Leiden 2300 RC
The Netherlands
Lindeman@lumc.nl
Inclusion criteria
1. Age >18;
2. Open elective AAA repair;
3. Current statin use.
Exclusion criteria
1. Statin intolerance;
2. Renal impairment (clearance <30 ml/min);
3. Liver impairment;
4. Excess alcohol consumption;
5. Any chronic inflammatory conditions;
6. Use of one or more of the following pharmaceutical agents: Itraconazol, Ketoconazol, Erytromycine, Claritromycine, Ciclosporine, Fibrates, immuo suppressives or HIV-protease inhibitors;
7. Inflammatory aneurysm.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2283 |
| NTR-old | NTR2410 |
| Other | MEC LUMC / CCMO : P10.085 / NL24354.058.09 ; |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |