跳至主要内容
临床试验/NCT03727958
NCT03727958Unknown不适用

Simultaneous Coronary Artery Evaluation and Lung Cancer Screening With a New Ultrafast-low-dose Computed Tomography Protocol: A Pilot Randomized Trial

University of Roma La Sapienza0 个研究点目标入组 100 人开始时间: 2018年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
100
主要终点
Safety of computed tomography as measured by effective radiation dose (as measured in mSv)

研究概览

简要总结

Cardiac computed tomography (CT) is often performed in patients who are at high risk for lung cancer in whom screening is currently recommended. This pilot randomized study will test the feasibility, safety and diagnostic ability of a novel ultra-low-dose CT protocol that allows concomitant coronary artery evaluation and lung screening. Current or former heavy smoker subjects with suspected or known coronary artery disease will be randomized to undergo CT assessment of either thoracic area only or both coronary arteries and thoracic area. Primary end-points will be the effective contrast and radiation doses.

详细描述

Cardiac computed tomography (CT) scan is an ideal diagnostic tool for identifying coronary artery disease in patients with low or intermediate risk. In recent years, cardiac CT is being often performed in patients who are at high risk either for coronary artery disease or lung cancer. The update edition of the National Institute for Health and Care Excellence (NICE) guidelines recommends cardiac CT as the first-line diagnostic tool for patients with new-onset chest pain due to suspected coronary artery disease. Also, symptomatic patients with known coronary artery disease and previous percutaneous coronary intervention who have an unclear stress test but whose presentation suggests a high likelihood of having an in-stent restenosis or a 'de novo' stenosis might benefit from cardiac CT. In 2014, the U.S. Preventive Services Task Force recommended annual lung cancer screening with ultra-low dose computed tomography for current and former heavy smokers aged 55 to 80 years. Indeed, lung cancer screening in patients with suspected or known coronary artery disease undergoing cardiac CT may provide the opportunity to implement recommendation for lung cancer screening in clinical practice.This pilot randomized study will test the feasibility, safety and diagnostic ability of a novel ultra-low-dose CT protocol that allows concomitant coronary artery evaluation and lung screening. Current or former heavy smoker subjects with suspected or known coronary artery disease will be randomized to undergo CT assessment of either thoracic area only or both coronary arteries and thoracic area. Primary end-points will be the effective contrast and radiation doses.

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

入选标准

  • •Symptomatic subjects with effort-induced or typical chest pain
  • •High probability of coronary artery disease
  • •Known coronary artery disease
  • •Willing to participate to the study
  • •Informed consent to undergo CT scan

排除标准

  • •Contraindications to iodinated contrast such as allergies and chronic kidney failure
  • •Any suspicion of pregnancy

研究组 & 干预措施

Lung and coronary CT assessment

Active Comparator

Subjects will undergo simultaneous CT assessment of both coronary arteries and thoracic area

干预措施: Lung and coronary CT assessment (Diagnostic Test)

Coronary CT assessment

Active Comparator

Subjects will undergo CT assessment of coronary arteries only

干预措施: Coronary CT assessment (Diagnostic Test)

结局指标

主要结局

Safety of computed tomography as measured by effective radiation dose (as measured in mSv)

时间窗: Through study completion, an average of 2 months

Measurement of the effective radiation dose (as measured in mSv) at time of computed tomography

次要结局

未报告次要终点

研究者

发起方
University of Roma La Sapienza
申办方类型
Other
责任方
Principal Investigator
主要研究者

Francesco Pelliccia

Professor

University of Roma La Sapienza

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