HEAVY SMOKINGSIMULTANEOUSNCT03727958
Simultaneous Coronary Artery Evaluation and Lung Cancer CT Screening
A study testing Lung and coronary CT assessment and Coronary CT assessment in people with HEAVY SMOKING, run by University of Roma La Sapienza.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- HEAVY SMOKING
- What is being tested?
- Lung and coronary CT assessment and Coronary CT assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2018to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Contraindications to iodinated contrast such as allergies and chronic kidney failure
- Any suspicion of pregnancy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Simultaneous Coronary Artery Evaluation and Lung Cancer Screening With a New Ultrafast-low-dose Computed Tomography Protocol: A Pilot Randomized Trial
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.
- Conditions
- HEAVY SMOKING
- Being tested
- Lung and coronary CT assessment, Coronary CT assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung and coronary CT assessmentDiagnostic test
Subjects will undergo simultaneous coronary arteries and thoracic CT assessment
Coronary CT assessmentDiagnostic test
Subjects will undergo coronary arteries CT assessment only
| Study group | Role | What they receive |
|---|---|---|
| Lung and coronary CT assessment | Active comparator | Subjects will undergo simultaneous CT assessment of both coronary arteries and thoracic area Receives: Diagnostic Test: Lung and coronary CT assessment |
| Coronary CT assessment | Active comparator | Subjects will undergo CT assessment of coronary arteries only Receives: Diagnostic Test: Coronary CT assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion, an average of 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2018
- Study start1 Nov 2018 (estimated)
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HEAVY SMOKINGStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Current or former heavy smoker subjects with suspected or known coronary artery disease will be randomized to undergo CT assessment of both coronary arteries and thoracic area for simultaneous coronary artery and lung cancer screening
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Pelliccia, University of Roma La Sapienza
- Investigators
- Francesco Pelliccia, MD, Principal investigator, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03727958
- Sponsor's protocol ID
- 2018/D/789
- Acronym
- SIMULTANEOUS
- Status last verified
- Oct 2018
- First submitted
- 28 Oct 2018
- Last updated
- 1 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simultaneous Coronary Artery Evaluation and Lung Cancer Screening With a New Ultrafast-low-dose Computed Tomography Protocol: A Pilot Randomized Trial
- ClinicalTrials.gov ID
- NCT03727958
- Acronym / sponsor ID
- SIMULTANEOUS / 2018/D/789
- Conditions
- HEAVY SMOKING
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 1 Nov 2018 (estimated)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 1 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Current or former heavy smoker subjects with suspected or known coronary artery disease will be randomized to undergo CT assessment of both coronary arteries and thoracic area for simultaneous coronary artery and lung cancer screening
| Arm | Type | Receives |
|---|---|---|
| Lung and coronary CT assessment | Active comparator | Diagnostic Test: Lung and coronary CT assessmentSubjects will undergo simultaneous CT assessment of both coronary arteries and thoracic area |
| Coronary CT assessment | Active comparator | Diagnostic Test: Coronary CT assessmentSubjects will undergo CT assessment of coronary arteries only |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Contraindications to iodinated contrast such as allergies and chronic kidney failure
- Any suspicion of pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung and coronary CT assessmentSubjects will undergo simultaneous coronary arteries and thoracic CT assessment | Diagnostic test | Lung and coronary CT assessment |
| Coronary CT assessmentSubjects will undergo coronary arteries CT assessment only | Diagnostic test | Coronary CT assessment |
Primary outcome
Safety of computed tomography as measured by effective radiation dose (as measured in mSv)
Time frame: Through study completion, an average of 2 months
Measurement of the effective radiation dose (as measured in mSv) at time of computed tomography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2018.
- Derived from this study: PubMed 31554878Gaudio 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco Pelliccia, MD principal investigator
University of Roma La Sapienza
Questions about this trial
What is this clinical trial studying?
A study testing Lung and coronary CT assessment and Coronary CT assessment in people with HEAVY SMOKING, run by University of Roma La Sapienza.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francesco Pelliccia, MD (+390633062615, f.pelliccia@mclink.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of computed tomography as measured by effective radiation dose (as measured in mSv) (time frame: Through study completion, an average of 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03727958, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2018.