T-cell inhibition with Mycophenolate Mofetil (MMF) attenuates T-cell number, T-cell activation and T-cell – monocyte interaction, thereby minimizing the T-cell-driven inflammatory amplification loop. The latter will contribute to improvement of anti…
Bron
Verkorte titel
Aandoening
Atherosclerotic vascular disease of the carotid artery
Ondersteuning
Amsterdam, the Netherlands
Onderzoeksproduct en/of interventie
Geen registraties gevonden.
Uitkomstmaten
Primaire uitkomstmaten
After 3 weeks of treatment: Immunostaining for: CD3, CD4, CD8, CD40L, CD69, CD86.
Achtergrond van het onderzoek
Patients with carotid artery stenosis undergoing endarterectomy will be randomized to either placebo or MMF treatment. Prior to scheduled surgery baseline measurements will be assessed and patients will start study medication. One week prior to surgery a second study will take place and measurements will be repeated. At time of surgery endarterectomy specimens will be collected for immunostaining to evaluate T-cell and monocyte/macrophage numbers and activation status as well as effects on endothelial and smooth muscle cells on atherosclerotic plaque composition.
Doel van het onderzoek
T-cell inhibition with Mycophenolate Mofetil (MMF) attenuates T-cell number, T-cell activation and T-cell – monocyte interaction, thereby minimizing the T-cell-driven inflammatory amplification loop. The latter will contribute to improvement of anti-atherogenic defence mechanisms, such as improvement of endothelial function and attenuation of the pro-inflammatory state.
Onderzoeksproduct en/of interventie
Participants will be randomized to either treatment with mycophenolate mofetil (MMF) or placebo.
Publiek
P.O. Box 22660
Sander Leuven, van
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5668675
s.i.vanleuven@amc.uva.nl
Wetenschappelijk
P.O. Box 22660
Sander Leuven, van
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5668675
s.i.vanleuven@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Consecutive patients with carotid artery stenosis (>70% diameter stenosis on angiography or ultrasonography) with ipsilateral transient ischemic attack (TIA) who are planned to undergo carotid endarterectomy (CEA) will be included and treated for a minimum of three weeks prior to surgery. These patients will be recruited at the outpatient department of Vascular Surgery.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Patients who are unable to tolerate MMF treatment, who withdraw their consent or those with any other medical condition or laboratory abnormality which in the opinion of the principal investigator could affect subject safety, preclude evaluation of response, or render unlikely that the patient would complete the study, are excluded.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL828 |
NTR-old | NTR841 |
Ander register | : N/A |
ISRCTN | ISRCTN84092396 |