Inhibition of Mast cell Activation in AtheroScleroTic lesions using an Anti-IgE antibody approach (MAST)

Recruiting

Conditions: Atherosclerotic narrowing of the carotid artery

Registration Number: NL-OMON23598

Lead Sponsor: ZonMW, Dutch Heart Foundation

Brief Summary: /A

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 80

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:
•Patient is 18 years of age or older
•Patient is able and willing to give their consent and sign an informed consent
•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

A potential subject who meets any of the following criteria will be excluded from participation in this study:
•Previous anaphylactic reaction (e.g. food allergy, medication such as antibiotics etc.)
•Previous CEA or CAS in the ipsilateral artery
•Patients with severe asthma or chronic urticaria which are treated or have been treated with omalizumab s.c.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome: The extent of mast cell activation in atherosclerotic plaque after administration of the study drugs (either omalizumab or placebo) measured by flow cytometry

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes:<br>The effect of administration of the study drugs (either omalizumab or placebo): <br>- Other inflammatory cells in the plaque (T-cell subsets, M1/M2 macrophages, neutrophils and B-cells)<br>- Circulating IgE<br>- Tryptase levels in blood<br>- Activation status of basophils <br>- Inflammatory markers such as: white blood cell count, hsCRP, IL-1beta and IL-6<br>- Tryptase and chymase levels in plaque<br>- Plaque phenotype (histology)<br><br>Secondary safety parameter:<br>- The onset of arterial thromboembolic events during follow-up