Contrast Enhancement on Coronary Computed Tomographic Angiography : Effects on Intra-Coronary Attenuation Using Low Iodine Concentrations While Maintaining Identical IDR (EICAR-Trial)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- intravascular contrast enhancement
研究概览
简要总结
Computed tomographic angiography (CTA) is an important prognostic tool with regard to the detection of coronary artery stenoses. Both iodine delivery rate (IDR; the amount of iodine delivered to the patient per second) and iodine concentration are decisive factors in the opacification of arterial vessels.
There remains to be some debate in the literature about whether the use of high iodine concentration contrast media is beneficial compared to lower iodine concentrations.
To date, there have not been any studies comparing intracoronary attenuation using concentrated contrast media lower than 300 mg I/ml at coronary CTA. For a reliable comparison of CM with different iodine concentrations, adapted injection protocols insuring an identical IDR (in g iodine per second) are mandatory. The investigators hypothesize that usage of lower iodine concentrations, while maintaining identical IDR and total iodine load, will result in comparable diagnostical intra-vascular attenuation in CTA.
详细描述
To evaluate intravascular contrast enhancement and image quality in coronary CTA using different iodine concentrations ranging from 240 to 370 mg iodine per ml, administered with an identical IDR and total iodine load.
To describe the effect of iodine concentration and flow rates on contrast bolus characteristics, eg time to peak, bolus homogeneity, injection pressure and patient comfort.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Double (Care Provider, 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
- •Atypical or typical chest pain
排除标准
- •Unstable angina
- •Hemodynamic instability
- •History of CAD
- •Pregnancy
- •Renal insufficiency (defined as glomerular filtration rate (GFR) <45ml/min or <60ml +diabetes
- •HR > 90 bpm and the inability to receive beta-blockers and iodine allergy
研究组 & 干预措施
240
Group 240 will receive CM with 240 mg Iodine/ml IDR 2.0 gI/s
干预措施: 240 mg Iodine (Drug)
300
Group 300 will receive CM with 300 mg Iodine/ml IDR 2.0 gI/s
干预措施: 300 mg Iodine (Drug)
370
Group 370 will receive CM with 370 mg Iodine/ml IDR 2.0 gI/s
干预措施: 370 mg Iodine (Drug)
结局指标
主要结局
intravascular contrast enhancement
时间窗: two years
intravascular contrast enhancement and image quality based on different contrast media (240, 300, 370) as measured by circular ROI in the target vessels using dedicated post processing.
次要结局
- patient comfort(two years)
- time to peak(two years)
- bolus homogeneity(two years)
研究者
Marco Das
Marco Das, MD, PhD
Maastricht University Medical Center