An interventional study of Lung and coronary CT assessment and Coronary CT assessment in HEAVY SMOKING, sponsored by University of Roma La Sapienza. Status unknown. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2018-11-01.
Sponsored by University of Roma La Sapienza · Not applicable, Interventional, and Diagnostic
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.
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.
University of Roma La Sapienza is the lead sponsor of 388 studies on the registry; 55 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects will undergo simultaneous CT assessment of both coronary arteries and thoracic area
Diagnostic Test: Lung and coronary CT assessment
Subjects will undergo CT assessment of coronary arteries only
Diagnostic Test: Coronary CT assessment
Subjects will undergo simultaneous coronary arteries and thoracic CT assessment
Subjects will undergo coronary arteries CT assessment only
Safety of computed tomography as measured by effective radiation dose (as measured in mSv)
Measurement of the effective radiation dose (as measured in mSv) at time of computed tomography
Time frame: Through study completion, an average of 2 months
No study locations are listed for this record.
Plan to share: No
This study is status unknown, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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University of Roma La Sapienza