Investigation of Dose Management Capabilities of Digital Variance Angiography: Contrast Media Dose Reduction in Patients Undergoing Carotid Artery Stenting - a Prospective Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- DSA-related contrast media use
研究概览
简要总结
Digital Variance Angiography (DVA) is a new tool in medical imaging with a proven image quality reserve (1, 2).
Previous studies have demonstrated the quality reserve of DVA in angiographic studies (1, 2), which allowed us to reduce contrast media use by 50% in carotid artery angiographic studies without affecting the image quality (3).
CAS is an alternative treatment option for carotid artery revascularization in selected patient groups. Similar to most of the minimally invasive endovascular interventions, CAS also carries the risk of contrast-induced acute kidney injury, which is considered to be an independent predictor of 30-day major adverse events (4).
The aim of this study is to apply DVA in patients undergoing carotid artery stenting (CAS) and utilize this technique to reduce contrast dose during the interventions, without affecting the intraprocedural radiation dose and the clinical outcome of the procedures. Investigators believe that the reduction in contrast media use and the associated image quality with the technique of DVA imaging can be incorporated into the everyday clinical practice, and will play an important role in improving the rate of contrast-induced acute kidney injury.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •Age > 18 y
- •Carotid stenosis defined as:
- •Stenosis ≥70% by computer tomography angiography (NASCET criteria); OR by duplex-ultrasound with ≥70% stenosis defined by a peak systolic velocity of at least 230 cm/s
- •Carotid stenosis is treatable with CAS
排除标准
- •History of stroke or TIA ipsilateral to the stenosis within 30 days of randomization
- •Acute myocardial infarction
- •Severe chronic kidney disease: GFR>30ml/min/m2
- •Severe heart failure: NYHA IV
- •Severe liver failure: Child-Pugh 3
- •Iodine contrast allergy
- •Coagulopathy
- •Hematological bleeding disorders
研究组 & 干预措施
Group A: Reduced contrast media dose group
Reduced contrast media protocol: extracranial carotid artery intervention (2-4 fps according to the institutional protocol).
Contrast administration with an automatic contrast injector: angiographic image acquisitions will be performed with 6 ml of 50% contrast media (3 ml iodined contrast media, 3 ml physiologic saline) with a 3 ml/s flow rate.
DSA and DVA images will be calculated; DVA images will be used for diagnosis and interventions.
干预措施: Carotid artery stenting with reduced contrast media protocol (Procedure)
Group A: Reduced contrast media dose group
Reduced contrast media protocol: extracranial carotid artery intervention (2-4 fps according to the institutional protocol).
Contrast administration with an automatic contrast injector: angiographic image acquisitions will be performed with 6 ml of 50% contrast media (3 ml iodined contrast media, 3 ml physiologic saline) with a 3 ml/s flow rate.
DSA and DVA images will be calculated; DVA images will be used for diagnosis and interventions.
干预措施: Carotid Duplex Ultrasound (Diagnostic Test)
Group B: Standard contrast media dose group
Standard contrast media protocol: extracranial carotid artery intervention (2-4 fps according to the institutional protocol).
Contrast administration with an automatic contrast injector: angiographic image acquisitions will be performed with 6 ml iodined contrast media with a 3 ml/s flow rate.
DSA and DVA images will be calculated; DSA images will be used for diagnosis and interventions.
干预措施: Carotid artery stenting with standard contrast media protocol (Procedure)
Group B: Standard contrast media dose group
Standard contrast media protocol: extracranial carotid artery intervention (2-4 fps according to the institutional protocol).
Contrast administration with an automatic contrast injector: angiographic image acquisitions will be performed with 6 ml iodined contrast media with a 3 ml/s flow rate.
DSA and DVA images will be calculated; DSA images will be used for diagnosis and interventions.
干预措施: Carotid Duplex Ultrasound (Diagnostic Test)
结局指标
主要结局
DSA-related contrast media use
时间窗: During the procedure
Volume of the iodinated contrast agent used for enhancing the image quality (mL)
Total procedural contrast media use
时间窗: During the procedure
Volume of the iodinated contrast agent used for enhancing the image quality (mL)
Image quality, graded by independent observers
时间窗: through study completion, an average of 1 year
Observations based on a 5-level Likert scale (1-poor image quality, 3-medium image quality, 5-outstanding image quality)
次要结局
- Residual stenosis(During the procedure)
- DSA-related dose area product(During the procedure)
- Total procedural time(During the procedure)
- Number of protocol changes during DVA usage(During the procedure)
- Focal neurological symptoms(During the procedure and up to 1 day)
- Preoperative and postoperative ipsilateral carotid artery flow by doppler ultrasound(Preoperatively and 1 day after the procedure)
- Total procedural dose area product(During the procedure)