VOLtage-based Contrast Media AdaptatioN in Coronary Computed Tomography Angiography (VOLCANIC-CTA): A Prospective Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Qualitative assessment of image quality
研究概览
简要总结
The purpose of this study is to prospectively evaluate the effectiveness of low-volume contrast media (CM) injection protocols adapted to tube voltage in patients undergoing Coronary Computed Tomography Angiography (CCTA).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Referred for a clinically indicated CCTA scan.
- •Subject must be 18 - 85 years of age.
- •Subject must provide written informed consent prior to any study-related procedures being performed.
- •Subject must be willing to comply with all clinical study procedures.
排除标准
- •Subject is a pregnant or nursing female. Exclude the possibility of pregnancy:
- •By testing (serum or urine beta HCG) within 24 hours before study agent administration, or
- •By surgical sterilization, or
- •Post-menopausal, with minimum one (1) year history without menses.
- •Subject is chosen by the automated tube voltage selection algorithm (or adjusted by the technologist) to be scanned using a tube voltage that is not 70, 80, 90, 100, 110, 120, or 130 kV.
- •Subject is chosen by the automated tube voltage selection algorithm (or adjusted by the technologist) to be scanned using a tube voltage that has previously reached the maximum subject number (20 subjects per tube voltage).
- •Subject has an acute psychiatric disorder.
- •Subject is unwilling to comply with the requirements of the protocol.
- •Subject has previously entered this study.
- •Subject has an allergy against iodinated contrast agents or pharmaceutical stressors used in this study.
- •Subject has impaired renal function (creatinine > 1.5 mg/dl).
- •Subject is in unstable condition.
研究组 & 干预措施
Low-volume contrast media injection protocol
Patients will receive a low-volume contrast media (Ultravist 370Mg I/Ml Solution for Injection) injection protocol that is tailored to a specific tube voltage. Tube voltages will be automatically selected by the scanner to be used for the CCTA acquisition.
干预措施: Ultravist 370Mg I/Ml Solution for Injection (Drug)
结局指标
主要结局
Qualitative assessment of image quality
时间窗: 2 years
This will be performed by two independent observers using a semi-quantitative rating scale of 1 - 5. Image quality will be graded on a five-point scoring system: 1 non-diagnostic; 2 limited diagnostic value; 3 adequate (presence of artifacts not limiting detection of luminal stenosis); 4 good; 5 excellent. Image quality assessments will be performed on both the investigative and control groups.
Quantitative assessment of image quality
时间窗: 2 years
Measurements and calculations will be performed by two independent observers who will be blinded to image acquisition parameters. Signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR) will be measured for all images.
次要结局
- Radiation dose of coronary CTA(2 years)