The Comparative Study of OCT，Gemstone CT and 320-detector Row Spiral CT for Evaluating Restenosis of Coronary Artery Stent
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Accuracy of detection of in-stent restenosis with the gemstone CT as compared to the 320-detector row spiral CT will be investigated
研究概览
简要总结
In-stent restenosis is a major reason of coronary heart disease recurrence .Even in drug eluting stent(DES), Restenosis rate could be up to 10% in diabetes and complex lesions though it was about 3-5% in general. It is particularly important that in-stent restenosis after implantation was early diagnosed and detected. The evaluation of OCT imaging is more accurate for narrow area calculation, more clear for narrow organization structure and more specific for detecting tissue types.It is currently the best way for restenosis histologic diagnosis.But it has many weakness such as the higher cost,an invasive test, expensive instrument, relatively complicated to operate,and etc.In this study, OCT image was regard as the "gold standard" of stent restenosis.
The improvement of spatial resolution of Gemstone CT can effectively improve the imaging quality and the measurement's accuracy of coronary artery stents.The diagnostic value of in-stent restenosis of Gemstone CT is higher than of the 320-detector row spiral CT. To a certain extent, the gemstone CT can replace OCT for examining the in-stent restenosis.
This study will examine the degree of in-stent restenosis by the gemstone CT and the 320-detector row spiral CT and compare the two ways on the basis of the result of OCT.
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
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 20-80， All genders
- •Unlimited time of implantation of coronary artery stents
- •Myocardial ischemia symptoms such as Chest tightness and/or chest pain in patients after stent implantation
- •No clinical symptoms, but myocardial ischemia suggested by other noninvasive tests
- •Routine re-testing 9-12 months after stent implantation.
排除标准
- •Renal insufficiency (serum creatinine > 120 umol/L)
- •Allergy of contrast
- •Severe heart failure
- •Uncontrollable heart rate or contraindication of taking metoprolol
- •Unstable condition
- •the ventricular rate beyond 70 beats / min and irregular rhythm after adjusting.
研究组 & 干预措施
Gemstone CT
Gemstone CT ：Discovery CT750 HD（high definition） ，GE（General Electric Co.） Healthcare, Milwaukee； CT image for patient with suspected in-stent restenosis which Gemstone CT or 320-detector row spiral CT was assigned randomly to patient
干预措施: CT image for patient with suspected in-stent restenosis (Device)
320-detector row spiral CT
320-detector row spiral CT：Aquilion One, Toshiba, Nasu, Japan. CT image for patient with suspected in-stent restenosis which Gemstone CT or 320-detector row spiral CT was assigned randomly to patient .
干预措施: CT image for patient with suspected in-stent restenosis (Device)
结局指标
主要结局
Accuracy of detection of in-stent restenosis with the gemstone CT as compared to the 320-detector row spiral CT will be investigated
时间窗: On the day in which a patient receives the gemstone CT and the 320-detector row spiral CT, estimated to take 10 mins
Masked examiners (CT specialists) will evaluate and compare the degree of in-stent restenosis of the gemstone CT and the 320-detector row spiral CT images for the presence and features of in-stent restenosis. In this study, OCT image was regard as the "gold standard" of in-stent restenosis.
次要结局
- Radiation burden of the the gemstone CT or the 320-detector row spiral CT and OCT(one month)