Prospective Randomized Trial On RadiaTion Dose Estimates Of CT AngIOgraphy In PatieNts Scanned With A Sequential Scan Protocol
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Compared with a helical scan protocol the use of a sequential scan protocol is associated with a comparable diagnostic image quality, while the radiation dose estimates are significantly reduced.
研究概览
简要总结
The objective of this study is to compare radiation dose of a standard spiral scan with the a new sequential scan protocol. We hypothesize that the sequential scan protocol is associated with a reduction in dose estimates of at least 20%, while the diagnostic image quality is not inferior.
Secondary endpoints of the study include quantitative image quality parameters, diagnostic accuracy for spiral versus sequential studies compared to invasive angiography in patients who underwent subsequent invasive coronary angiography.
详细描述
All patients scheduled for a coronary CT scan are screened for inclusion and exclusion criteria. Patients are included if they have stable sinus rhythm (heart rate <75 bpm for dual source CT and <65 bpm for 64-slice CT). Informed signed consent is obtained from these patients and the CT scan is prepared. After topogram scan and the native scan for Ca-Scoring, patients are randomized in two groups with the use of sealed envelopes. After that contrast-enhanced coronary CT angiography is performed with the standard spiral protocol or with the sequential protocol.
The CT examination is evaluated by two experienced investigators on a per-vessel basis and all results and study-related data are collected in a dedicated database. For assessment of image quality, a previously established 4-point score system is used and quantitative image quality parameters are measured.
A 30 day follow-up after the CT examination aims to evaluate if patients underwent invasive coronary angiography or were scheduled for a myocardial stress / perfusion test (such as stress-echocardiography, myocardial scintigraphy or stress perfusion imaging by MRI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •patients with an indication for a coronary CT angiography (planned evaluation of the coronary arteries)
- •stable sinus rhythm
- •heart rate < 75 bpm with dual-source CT or < 65 bpm with single-source CT
- •signed informed consent
排除标准
- •non-ECG triggered studies
- •non-coronary CTA studies, e.g. bypass graft CTAs, pre- or post EP studies, CABG planning studies
结局指标
主要结局
Compared with a helical scan protocol the use of a sequential scan protocol is associated with a comparable diagnostic image quality, while the radiation dose estimates are significantly reduced.
时间窗: 1 month
次要结局
- impact of the sequential scan protocol on quantitative image quality parameters, e.g. image noise, signal and contrast intensity, signal- and contrast-to-noise-ratios(30 days)
- diagnostic accuracy (sensitivity, specificity as well as positive and negative predictive values) for studies scanned with helical vs. sequential scan protocol when compared with invasive coronary angiography on a per-vessel based analysis(30 days)
- frequency of non-diagnostic CTA studies when comparing studies scanned with the helical vs. the sequential scan protocol(30 days)