Coronary CT Angiography Using a Novel 3rd Generation Dual-Source CT System: Diagnostic Performance and Potential for Reduction in Radiation Dose and Contrast Material Requirement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Radiation dose and contrast material
研究概览
简要总结
Coronary CT angiography is used to examine the coronary arteries in a non-invasive way when a patient is suspected of having coronary artery disease. The test, however, requires relatively high levels of radiation, which have been linked to DNA damage and cancer, and the use of contrast material, which can affect kidney function. The SOMATOM Force, a new third-generation CT scanner manufactured by Siemens, was recently installed at MUSC and holds the potential to obtain quality images while also reducing radiation dose and contrast material. This study aims to test the diagnostic ability of the SOMATOM Force in detecting coronary artery disease and also see if radiation dose and contrast material are reduced compared to the previous 2nd generation scanners. It is suspected that the Force will provide clinical quality images while decreasing radiation dose and contrast material required.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must be between 18-90 years of age.
- •Subject must have been referred for a clinically indicated cardiac catheterization or nuclear cardiac perfusion study.
- •Subject must provide written informed consent prior to any study-related procedures being performed.
- •Subject must be willing to comply with all clinical study procedures.
排除标准
- •Subject is a pregnant or nursing female. Exclude the possibility of pregnancy:
- •By testing (urine βHCG) within 24 hours before contrast agent administration, or
- •By surgical sterilization, or
- •Post menopausal, with minimum one (1) year history without menses.
- •Subject has an acute psychiatric disorder or is cognitively impaired.
- •Subject is using or is dependent on substances of abuse.
- •Subject is unwilling to comply with the requirements of the protocol.
- •Subject has decreased renal function (eGFR <45)
- •Subject has an allergy against iodinated contrast agents.
- •Subject is in acute unstable condition.
研究组 & 干预措施
Force
Patients receiving coronary CT angiography on the SOMATOM Force before clinically indicated cardiac catheterization or after clinically indicated nuclear stress test
干预措施: Coronary CT angiography on SOMATOM Force (Procedure)
Control
Patients who have already received comparable CT examinations on current routine 2nd generation dual-source CT systems
干预措施: Previous coronary CT angiography on 2nd generation CT scanner (Procedure)
结局指标
主要结局
Radiation dose and contrast material
时间窗: one year
To determine the potential for reductions in radiation dose and contrast material requirements by performing coronary CT angiography at low tube potential with the new CT system.
次要结局
- Diagnostic accuracy(one year)
研究者
U. Joseph Schoepf, MD
Professor
Medical University of South Carolina