Feasibility and Data Collection of Dual Energy Cardiac CT on a Wide Coverage System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Collect Data
研究概览
简要总结
This study is intended to collect clinical feasibility data using this prototype research mode for the purposes of understanding potential clinical impact, potential limitations and strengths, and to further develop the technique through development of image reconstruction and processing approaches or identification of other areas of development required.
详细描述
Up to 38 subjects may be enrolled to achieve the target number of 30 evaluable subjects. Withdrawn or discontinued subjects who are enrolled and received the investigational scan, may be replaced. Subject participation will be deemed complete once the diagnostic and investigational scans are completed. A subject is considered evaluable when images and raw data from the diagnostic single energy cardiac CT scan and raw data from the investigational dual energy cardiac CT scan have been collected successfully and demonstrate a diagnostic interpretation.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients > 50 years old undergoing routine cardiac CT imaging exam;
- •Patients that within last 12 months did not undergo medical procedures involving ionizing radiation;
- •Signed informed consent.
排除标准
- •Contradictions to contrast;
- •Contraindications for beta blocker;
- •High heart rate ≥75 BPM;
- •Atrial Fibrillation;
- •Arrythmia or irregular heartbeats;
- •Pregnant women;
- •Patients lacking capacity in providing informed consent
- •Patients who did participate in prior research studies with ionizing radiation in the last 12 months.
结局指标
主要结局
Collect Data
时间窗: through study completion, an average of 1 year
Data will be collected from the scanner for future post-processing and engineering development. There is no analysis planned at this time for the data, simply data collection.
次要结局
- Evaluation- Likert Scale(through study completion, an average of 1 year)