Carotid Risk Prediction (CRISP) Consortium
试验速览
- 阶段
- 不适用
- 入组人数
- 800
- 试验地点
- 5
- 主要终点
- Adverse outcome model performance
研究概览
简要总结
Develop adverse event prediction and plaque phenotype classification models for patients with known or suspected carotid artery disease.
详细描述
Develop adverse event prediction and plaque phenotype classification models using plaque morphology and composition assessment of CTA which has been validated by histology, applied to representative cohort of patients. Generalizability of models is enhanced by using validated rather than only raw image inputs. Demographic, clinical, and outcome data is collected for enrolled patients as well as information on events and interventions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Subjects must have two (or more) neck CTAs at least 6 months apart of sufficient quality as documented in the vascuCAP Reading Manual.
- •Atherosclerotic plaque must be visualized within the carotid artery.
排除标准
- •Subjects without visible plaque within the carotid artery
- •Subject with insufficient CTA image quality (defined strictly as documented in the vascuCAP Reading Manual)
结局指标
主要结局
Adverse outcome model performance
时间窗: 2 years
Develop adverse event model for major adverse neurological events (MANE) prediction on large retrospective cohort (and enable a prospective collection subsequent to this study). Consistent with this primary endpoint is the evaluation of all imaging-derived data that has a bearing on the diagnosis and prognosis of the subject.
次要结局
未报告次要终点