Xenetix® 350: Comparative Assessment of Image Quality for Coronary CT Angiography (X-ACT Study)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Guerbet
- 入组人数
- 468
- 试验地点
- 23
- 主要终点
- Rate of Patients With Evaluable CT Scans i.e. Allowing Identification of Coronary Artery Stenosis According to Off-site Reading Assessment
研究概览
简要总结
The purpose of this study is to demonstrate the (statistical) non-inferiority of iobitridol (Xenetix® 350) when compared to contrast agents with higher iodine concentrations, iopromide (Ultravist® 370) and iomeprol (Iomeron® 400) in terms of coronary CT scan evaluability (quality and interpretability of images).
详细描述
Patients suspected of coronary artery disease were submitted to coronary CT angiography using either iobitridol or contrast agents with higher iodine concentrations (iopromide or iomeprol). Independent off-site readers evaluated image quality regarding the ability to identify coronary artery stenosis (score 0- non evaluable to 4- excellent quality). The study was aimed at showing the non-inferiority of iobitridol in its ability to provide evaluable CT scans for the identification of coronary stenosis.
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
- •Male or female adult patient (having reached legal majority age)
- •Symptomatic patient suspected for coronary artery disease scheduled for a coronary CT angiography
排除标准
- •Patient with a heart rate > 65 beats per minute (bpm) and contraindication or intolerance to b-blocker administration
- •Patient with arrhythmia or non-sinus rhythm
- •Patient with decompensated heart failure
- •Patient with evidence of ongoing or active clinical instability (suspected or known acute myocardial infarction, cardiac shock, acute pulmonary oedema)
- •Patient who has previously undergone coronary artery bypass graft
- •Patient who has previously undergone percutaneous transluminal coronary stent placement
- •Patient with artificial heart valve
- •Patient with known moderate to severe aortic stenosis
研究组 & 干预措施
Iobitridol
Patients were IV injected with a single dose of iobitridol before a coronary CT angiography
干预措施: iobitridol (Drug)
Iopromide
Patients were IV injected with a single dose of iopromide before a coronary CT angiography
干预措施: iopromide (Drug)
Iomeprol
Patients were IV injected with a single dose of iomeprol before a coronary CT angiography
干预措施: iomeprol (Drug)
结局指标
主要结局
Rate of Patients With Evaluable CT Scans i.e. Allowing Identification of Coronary Artery Stenosis According to Off-site Reading Assessment
时间窗: < 24h
Evaluability was based upon the off-site assessment of 18-coronary segments graded for image quality with a 5-point scale.4= Excellent quality, fully confidence without any doubts concerning the presence/absence of luminal stenosis; 3= Good quality, confidence concerning the presence/absence of luminal stenosis; 2= Moderate quality, relative confidence, with minor doubts concerning the presence/absence of luminal stenosis; 1= Poor quality, some doubts concerning the presence/absence of stenosis; 0= Non diagnostic. A patient's CT scan was considered as evaluable for identification of coronary artery stenosis if none of the 18 coronary segments had a score of 0.
次要结局
- Coronary Track Rate(<24h)
- Average Signal Attenuation After IV Injection of Contrast(<1h)
- Average Signal-to-Noise Ratio (Average SNR)(<1h)
- Average Image Quality According to Off-site Reading(<24h)
- Average Contrast-to-noise Ratio (Average CNR)(<1h)