Prediction of Atherosclerotic Plaque Burden Progression With Sequential Coronary CT-angiography and Biomarkers
试验速览
- 阶段
- 不适用
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Plaque progression as defined by sequential CCTA using dedicated software.
研究概览
简要总结
Currently, cardiac computed tomography angiography (CCTA) is a well-implemented non-invasive diagnostic imaging modality in patients with stable chest pain. Besides conventional CT-reading, CCTA is also capable to identify several morphologic and geometric characteristics of atherosclerotic plaques. Recently, the investigators showed that the use of semi-automated plaque quantification algorithm identified parameters predictive for acute coronary syndrome on top of clinical risk profiling and conventional CT-reading. In addition, several atherotrombosis biomarkers, like high-sensitivity cardiac troponins, are described as related to coronary artery disease and cardiovascular events. Prospective data with sequential analysis of atherosclerotic plaques combined with different atherothrombosis biomarkers are currently lacking, but will provide important clues about the pathophysiology of plaque progression and atherothrombosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a recent history of (a)typical chest pain, who underwent a coronary calcium score scan as well as CCTA.
- •Age older than 18 years and competent to perform written informed consent.
- •At least 2 coronary segments with plaques:
- •1 proximal lesion.
- •At least one coronary plaque consisting of a non-calcified or mixed component.
排除标准
- •Unstable angina.
- •Renal insufficiency: calculated estimated glomerular filtration rate <45mL/min.
- •Iodine allergy.
- •Pregnancy.
- •Known history of atrial fibrillation.
- •Inconclusive baseline computed coronary CT-angiography.
- •Patients which are currently on oral vitamin K antagonists.
- •Patients which are currently using selective anticoagulants.
- •Previous PCI.
- •Previous or planned coronary artery bypass grafting.
- •Patients whereby the baseline CCTA was performed by a retrospective ECG-gated 'helical' protocol due to a high (>90bpm) or irregular heart rate.
结局指标
主要结局
Plaque progression as defined by sequential CCTA using dedicated software.
时间窗: 1 year.
次要结局
未报告次要终点