Prospective Observational Study of Image Quality and Radiation Dose Associated With Cardiac Scans in Modern CT Scanners
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 主要终点
- Intraluminal Enhancement of Coronary Arteries
研究概览
简要总结
The main objective of this study is to evaluate the dose efficiency of coronary CT angiography (CTA) using a photon counting detector CT (PCD-CT) with the dose efficiency of coronary CT angiography of prior CT generations. 100 patients with a clinical indication for coronary CT angiography will be prospectively enrolled and undergo coronary CTA on a PCD-CT. For comparison, a matched retrospective cohort of 100 patients will be created who had undergone on a prior scanner generation (retrospective cohort).
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
- 否
入选标准
- •indication for coronary CTA confirmed by board-certified radiologist ('justified indication' according to German/European radiation protection law) AND
- •patient (is able to give informed consent and) has given informed consent.
排除标准
- •contraindications to (iodine based) iv contrast material: known allergy to iodine-based iv contrast, acute or high-grade chronic kidney insufficiency with an estimated glomerular filtration rate < 30 ml/min/1.73 m², latent or manifest hyperthyroidism
- •known or suspected pregnancy
- •lactating mothers
结局指标
主要结局
Intraluminal Enhancement of Coronary Arteries
时间窗: 1 year
measured on thin-slice reconstructions, in Hounsfield units
Image Noise
时间窗: 1 year
measured on thin-slice reconstructions, in Hounsfield units
Dose-Length Product (DLP)
时间窗: 1 year
Integrative descriptor for the x-ray dose applied during acquisition; can be read out from the scan protocol.
Overall subjective image quality
时间窗: 1 year
as assessed by board-certified and speciality-trained radiologists on a 5-point Likert scale
次要结局
- Diagnostic Accuracy of Coronary Artery Stenosis Assessment in Comparison with invasive catheter angiography(1 year)