Plaque Stratification Using Ccta in Coronary ARtery Disease (PoSTCARD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Time to adverse outcome
研究概览
简要总结
Develop time-to-event prediction and plaque phenotype classification models for patients with known or suspected coronary artery disease.
详细描述
Develop time-to-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 last known well dates.
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
- •Subject must have successfully completed at least one (possibly multiple) CCTA for known or suspected coronary artery disease, which was positive for coronary atherosclerotic changes.
- •Subject must have been ≥ 18 years of age at the time of the CCTA
排除标准
- •Subject has a history of percutaneous coronary intervention (PCI) with stent implantation and/or coronary artery bypass grafting (CABG)
- •CCTA taken less than 3 months after deployment of new scanner
- •Subject with insufficient CCTA image quality
结局指标
主要结局
Time to adverse outcome
时间窗: >= 2 years
Develop time-to-event model for major adverse cardiac events (MACE) 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