CClinicalTrials.gg
Status unknownNCT03727958SIMULTANEOUSUpdated Nov 1, 2018

Simultaneous Coronary Artery Evaluation and Lung Cancer CT Screening

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

The sponsor has not verified this record recently (last verified Oct 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • HEAVY SMOKING
03

In context

Lead sponsor

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.

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Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    Lung and coronary CT assessment

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

    Diagnostic Test: Lung and coronary CT assessment

  • Active comparator
    Coronary CT assessment

    Subjects will undergo CT assessment of coronary arteries only

    Diagnostic Test: Coronary CT assessment

Interventions

  • Diagnostic testLung and coronary CT assessment

    Subjects will undergo simultaneous coronary arteries and thoracic CT assessment

  • Diagnostic testCoronary CT assessment

    Subjects will undergo coronary arteries CT assessment only

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What researchers measure

Primary outcomes

  1. 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

07

Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Gaudio C, Tanzilli A, Mei M, Moretti A, Barilla F, Varveri A, Paravati V, Tanzilli G, Ciccaglioni A, Strano S, Pellegrini M, Barillari P, Pelliccia F. Concomitant screening of coronary artery disease and lung cancer with a new ultrafast-low-dose Computed Tomography protocol: A pilot randomised trial. Sci Rep. 2019 Sep 25;9(1):13872. doi: 10.1038/s41598-019-50407-6. PubMed 31554878 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03727958
Lead sponsor
University of Roma La Sapienza
Responsible party
Francesco Pelliccia (Professor, University of Roma La Sapienza) — Principal investigator
First posted
Nov 1, 2018
Start date
Nov 1, 2018 (estimated)
Primary completion
Dec 31, 2018 (estimated)
Completion
Dec 31, 2018 (estimated)
Last update
Nov 1, 2018

Study contacts

Francesco Pelliccia, MD
Contact
f.pelliccia@mclink.it
+390633062615
Francesco Gaudio, MD
Contact
f.pelliccia@mclink.it
+390633062615
Francesco Pelliccia, MD
principal investigator · University of Roma La Sapienza

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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