Simultaneous Coronary Artery Evaluation and Lung Cancer Screening With a New Ultrafast-low-dose Computed Tomography Protocol: A Pilot Randomized Trial
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
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
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
Francesco Pelliccia
Professor
University of Roma La Sapienza
