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临床试验/NCT05994014
NCT05994014招募中不适用

PET/CT vs. Cardiac CT for Detecting Coronary Atherosclerotic Disease

Johns Hopkins University2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2023年7月1日最近更新:
适应症
干预措施

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

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

Other

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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