Inhibition of Mast cell Activation in AtheroScleroTic lesions using an Anti-IgE antibody approach (MAST-trial)
Phase 2
- Conditions
- carotid narrowingatherosclerotic carotid artery stenosis10003216
- Registration Number
- NL-OMON54785
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 80
Inclusion Criteria
Patient has a symptomatic or asymptomatic atherosclerotic carotid artery
stenosis of at least 50% narrowing of the lumen (calculated by using criteria
equivalent to the NASCET method) wherefore revascularisation through carotid
endarterectomy is planned routinely.
Exclusion Criteria
Any anaphylactic reaction in the medical history
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is activated mast cell as the percentage of the total mast<br /><br>cell (CD45+CD117+Fc*R+ cells) count, determined by flow cytometry. Normal<br /><br>unactivated mast cells are positive for the markers CD45, CD117 and Fc*R. In<br /><br>addition, activated mast cells are positive for IgE and the activationmarkers<br /><br>CD203c and CD63. The primary study parameter is the % of mast cell activation<br /><br>determined by flow cytometry.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints are (endpoints will be compared between treatment groups<br /><br>and for point 2,3,5 and 6 between baseline and day 3):<br /><br>(1) Local inflammatory status of atherosclerotic plaque (measuring T-cell<br /><br>subsets, M1/M2 macrophages, neutrophils and B-cells counts)<br /><br>(2) Plasma tryptase levels<br /><br>(3) Level of infection parameters (complete blooudcount, hsCRP, IL-1beta and<br /><br>IL-6)<br /><br>(4) Plaque characterization (using histology)<br /><br>(5) Serum IgE levels<br /><br>(6) Basophil activation status</p><br>