Heat Shock Protein 47: A Novel Biomarker of Thrombosis Risk
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 340
- 试验地点
- 2
- 主要终点
- Platelet levels of heat shock protein 47 (HSP47) in patients with thrombosis compared to healthy controls
研究概览
简要总结
The goal of this observational study is to learn if the novel biomarker Heat shock protein 47 (HSP47) can be used as a prognostic marker for vascular disease in people with acute venous thromboembolism (VTE), myocardial infarction (AMI) or ischaemic stroke compared to healthy volunteers. The main questions it aims to answer are:
- Are platelet levels of HSP47 higher in patients with acute VTE, AMI or stroke, compared to healthy volunteers.
- Does platelet levels of HSP47 remain elevated in patients with acute thrombotic events compared to healthy volunteers at 3 and 12-months of follow-up.
- Are platelet levels of HSP47 postively associated with platelet function and negatively associated with fibrinolytic capacity in patients with an acute thrombotic event.
Participants with VTE, AMI or stroke will be giving a blood sample at diagnosis and again after 3 and 12 months of follow-up. Healthy volunteers will be giving a blood sample once.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years of age or older
- •Informed consent
- •Deep vein thrombosis confirmed on ultrasonography OR
- •Pulmonary embolism confirmed on computed tomography angiography (CTA)
- •ST-segment elevation on electrocardiogram (ECG) AND
- •Culprit lesion(s) on coronary angiography
- •Stroke group:
- •Stroke confirmed on magnetic resonance imaging AND
- •Atrial fibrillation (Detected on ECG, telemtry or Holter monitoring) AND
- •Stroke localisation classic for AFib: cortical, cerebellar, brainstem or subcortical >1.5 cm in diameter
- •Healthy group:
排除标准
- •<18 years of age
- •no informed consent
- •Known haematological disorders
- •Active haematological malignancy
- •Severe renal insufficiency defined as eGFR <15 or dialysis
- •VTE - Pulmonary embolism incidentally detected by CTA conducted for purposes unrelated to pulmonary embolism assessment without concomitant DVT
- •Coronary dissection
- •Takotsubo cardiomyopathy
- •Stroke from other causes, e.g. findings pointing towards large vessel disease
- •Known acute or chronic disease
- •Prior VTE, AMI, stroke or other thromboembolic event
结局指标
主要结局
Platelet levels of heat shock protein 47 (HSP47) in patients with thrombosis compared to healthy controls
时间窗: From enrollment to end of follow-up at 12 months after enrollment. At 3 time points.
The level of HSP47 on platelets will be measured in a bloodsample. It will be measured using proteomics and flow cytometry.
次要结局
- Platelet levels of HSP47 in association to platelet function(From enrollment to 12 months of follow-up. Measured at 3 time points.)
- Changes in platelet levels of HSP47 over time in patients with thrombosis(From enrollment to 12 months of follow-up. Measured at 3 time points.)
- Platelet levels of HSP47 in association to fibrinolytic capacity(From enrollment to 12 months of follow-up. Measured at 3 time points.)