2024-513581-19-00已完成4 期
Inhibition of Mast cell Activation in AtheroScleroTic lesions using an Anti-IgE antibody approach (MAST)
Universitair Medisch Centrum Utrecht1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年8月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Primary study endpoint is the % of mast cell activation, which can be measured with flow cytometry.
研究概览
简要总结
To determine whether short anti-IgE treatment with an anti-IgE monoclonal antibody (omalizumab) can limit intraplaque mast cell activation in atherosclerotic plaques, acquired by a carotid endarterectomy.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patient is 18 years or 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 plannend routinely.
排除标准
- •Previous anaphylactic reaction (e.g. food allergy, medication such as antibiotics)
- •Previous carotid endarterectomy (CEA) or carotid artery stenting (CAS) in the ipsilateral artery.
- •Patients with severe asthma or chronic urticaria which are treated or have been treated with omalizumab subcutaneously.
结局指标
主要结局
Primary study endpoint is the % of mast cell activation, which can be measured with flow cytometry.
Primary study endpoint is the % of mast cell activation, which can be measured with flow cytometry.
次要结局
- 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.
研究者
DHS Onderzoeksbureau
Scientific
Universitair Medisch Centrum Utrecht
研究点 (1)
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