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

Conditions

Carotid artery stenosis

Brief summary

Primary study endpoint is the % of mast cell activation, which can be measured with flow cytometry.

Detailed description

The effect of omalizumab on the level of inflammation of patients with atherosclerosis by measuring the percentage of inflammatory cells (T cell subsets, M1/M2 macrophages, neutrophils, B-cells) in the immune cell suspension obtained from the plaque using flow cytometry., The effect of omalizumab treatment on circulating IgE levels determined by ELISA., The effect of omalizumab on tryptase levels (and thereby on systemic mast cell activation)., The effect of omalizumab on plaque levels of tryptase and chymase., The effect of omalizumab on the activation status of basophils by using a BAT assay., The effect of omalizumab on plaque phenotype such as necrotic area, cellular composition and stability parameters using histology., The effect of omalizumab on circulating white blood cell count, hsCRP, IL-1B and IL-6., As a secondary safety parameter the occurence of arterial thromboembolic events will be documented.

Related papers

No related papers found yet.

Interventions

DRUGXolair 150 mg solution for injection in pre-filled syringe

DRUGPhysiological saline

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Primary study endpoint is the % of mast cell activation, which can be measured with flow cytometry.	—

Secondary

Measure	Time frame
The effect of omalizumab on the level of inflammation of patients with atherosclerosis by measuring the percentage of inflammatory cells (T cell subsets, M1/M2 macrophages, neutrophils, B-cells) in the immune cell suspension obtained from the plaque using flow cytometry., The effect of omalizumab treatment on circulating IgE levels determined by ELISA., The effect of omalizumab on tryptase levels (and thereby on systemic mast cell activation)., The effect of omalizumab on plaque levels of tryptase and chymase., The effect of omalizumab on the activation status of basophils by using a BAT assay., The effect of omalizumab on plaque phenotype such as necrotic area, cellular composition and stability parameters using histology., The effect of omalizumab on circulating white blood cell count, hsCRP, IL-1B and IL-6., As a secondary safety parameter the occurence of arterial thromboembolic events will be documented.	—

Measure

Time frame

The effect of omalizumab on the level of inflammation of patients with atherosclerosis by measuring the percentage of inflammatory cells (T cell subsets, M1/M2 macrophages, neutrophils, B-cells) in the immune cell suspension obtained from the plaque using flow cytometry., The effect of omalizumab treatment on circulating IgE levels determined by ELISA., The effect of omalizumab on tryptase levels (and thereby on systemic mast cell activation)., The effect of omalizumab on plaque levels of tryptase and chymase., The effect of omalizumab on the activation status of basophils by using a BAT assay., The effect of omalizumab on plaque phenotype such as necrotic area, cellular composition and stability parameters using histology., The effect of omalizumab on circulating white blood cell count, hsCRP, IL-1B and IL-6., As a secondary safety parameter the occurence of arterial thromboembolic events will be documented.

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Countries

Netherlands

Outcome results

None listed