跳至主要内容
临床试验/NCT02549794
NCT02549794已完成不适用

Comparison of Image Quality of Coronary Computed Tomography Angiography bEtweeN High concenTRATion and Low concEntration Contrast Agents(CONCENTRATE Trial)

Yonsei University2 个研究点 分布在 2 个国家目标入组 80 人开始时间: 2015年7月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
2
主要终点
Assess HU (Hounsfield unit) for image quality of 3 different protocol of contrast media in coronary CT angiography

研究概览

简要总结

According to CT technology development, cardiac CT is very useful examination as noninvasive examination and the accuracy in locating lesions has increased to 95%. Specifically, cardiac CT has been performing a gateway role in reducing invasive cardiac angiography implemented solely for the purpose of diagnosis because of the invasive testing of makeshift cardiac angiography. However, cardiac CT also comes with the disadvantage that patients cannot avoid being exposed to radiation, so there has been much effort in appealing to reduce exposed radiation dose. Of these methods, the most effective is the method of repeatedly reconstitution by way of synchronized prospective ECG while using low tube-based potential. According to recent studies, the SNR(Signal Noise Ratio) and CNR(Contrast Noise Ratio) values representing image quality have been higher compared to the combined method of image reconstruction by makeshift filtered back projection and condition of image acquisition by patient BMI. Also, the administered amount of contrast agent can be reduced for achieving the same contrast effect due to the advantage of the increased effect of contrast enhancement by using low tube voltage. Therefore, the efficacy studies of using low concentration of contrast agents in conditions of using low tube voltage are being processed.

This study intends to prove that image quality does not deteriorate by suitable image reconstruction method with low concentration contrast agent compared to the combined method of the makeshift filtered back projection image reconstruction method and the conditions of image acquisition according to BMI with general amount of contrast agent.

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
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults at least 20 years old
  • Subject who had requested a coronary CT angiography as per a clinical disease

排除标准

  • Subject suspected as having myocardial infarction, unstable angina pectoris, coronary artery disease
  • Subject with heart attack within 40 days prior to the CT scan
  • Subject with diagnosed complicated heart anomaly
  • BMI (body mass index) > 35kg/m2
  • Serum creatinine ≥1.5mg/dl of renal insufficiency
  • Subject with pregnancy or unknown pregnancy
  • Subject with history of hypersensitivity reaction of contrast agents
  • Subject has contraindication of using nitroglycerine
  • Subject has plan to participate or enrolled in other randomized clinical trial for cardiovascular disease.
  • Subject has contraindication of using adenosine (e.g. bronchial asthma, 2-3 degree AV block, sick sinus syndrome, SBP (systolic blood pressure) less than 90mmHg, recent prescribed history of dipyridamole, hypersensitivity of adenosine)

结局指标

主要结局

Assess HU (Hounsfield unit) for image quality of 3 different protocol of contrast media in coronary CT angiography

时间窗: 7 days

次要结局

  • Diagnostic accuracy of coronary CT angiography compared to invasive coronary angiography(7 days)
  • Qualitative evaluation of image quality of coronary artery(7 days)
  • Quantitative analysis of image quality using measuring HU(7 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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