PET/CT vs. Cardiac CT for Detecting Coronary Atherosclerotic Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Diagnostic accuracy of detecting coronary atherosclerosis
研究概览
简要总结
Early detection of coronary atherosclerotic disease facilitates adequate prevention. The purpose of this study is to compare an assessment of coronary atherosclerotic disease burden by positron emission tomography / computed tomography (NaF-PET/CT) with those of conventional and ultra-high-resolution-CT (UHR-CT) in patients with suspected coronary artery disease. For this purpose, the investigators plan to include 33 patients with symptoms concerning for CAD who have been referred for cardiac CT testing.
详细描述
Early detection of coronary atherosclerotic disease facilitates adequate prevention. 18 Fluoride (F) -sodium fluoride PET/CT (NaF-PET/ CT) has been shown to detect aortic microcalcification as early manifestation of atherosclerosis in experimental and early clinical investigations. The capability of NaF-PET/CT to detect coronary atherosclerotic disease in humans remains unclear. Given its sensitivity to detect vascular microcalcification undetectable by conventional CT, NaF-PET/CT may be an attractive, noninvasive test for early detection of coronary atherosclerosis.
The purpose of this study is to compare an assessment of coronary atherosclerotic disease burden by positron emission tomography / computed tomography (NaF-PET/CT) with those of conventional and ultra-high-resolution-CT (UHR-CT) in patients with suspected coronary artery disease (CAD). For this purpose, the investigators plan to include 33 patients with symptoms concerning for CAD who have been referred for cardiac CT testing. In addition to the clinically indicated and performed cardiac CT scan, participants will be asked to also undergo NaF-PET/CT for comparison of atherosclerosis assessment among the two tests (single center, prospective diagnostic accuracy study).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Male or female patients
- •18 years or older
- •referred for coronary CT angiography because of suspected coronary heart disease (CHD) with stable symptoms
排除标准
- •The patient has a history of coronary heart disease, defined by prior myocardial infarction or prior coronary artery revascularization.
- •Pregnancy.
- •Atrial fibrillation.
- •Morbid obesity defines as a body mass index of >
- •The patient has any other clinically significant medical condition that in the opinion of the Investigator could impact the patient's ability to successfully complete the trial.
研究组 & 干预措施
Main group
All patients undergo both, experimental and standard, tests
干预措施: PET/CT (Diagnostic Test)
结局指标
主要结局
Diagnostic accuracy of detecting coronary atherosclerosis
时间窗: 60 days
PET/CT Sensitivity to detect any atherosclerosis by CT angiography
Correlation of atheroma volume [mm3]
时间窗: 60 days
Coronary atheroma volume by PET/CT vs. CT total atheroma volume
次要结局
未报告次要终点
