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Simultaneous Coronary Artery Evaluation and Lung Cancer CT Screening (SIMULTANEOUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03727958
Recruitment Status : Not yet recruiting
First Posted : November 1, 2018
Last Update Posted : November 1, 2018
Sponsor:
Information provided by (Responsible Party):
Francesco Pelliccia, University of Roma La Sapienza

Brief 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.

Condition or disease Intervention/treatment Phase
HEAVY SMOKING Diagnostic Test: Lung and coronary CT assessment Diagnostic Test: Coronary CT assessment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Diagnostic
Official Title: Simultaneous Coronary Artery Evaluation and Lung Cancer Screening With a New Ultrafast-low-dose Computed Tomography Protocol: A Pilot Randomized Trial
Estimated Study Start Date : November 1, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Subjects will undergo simultaneous coronary arteries and thoracic CT assessment

Active Comparator: Coronary CT assessment
Subjects will undergo CT assessment of coronary arteries only
Diagnostic Test: Coronary CT assessment
Subjects will undergo coronary arteries CT assessment only




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03727958


Contacts
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Contact: Francesco Pelliccia, MD +390633062615 f.pelliccia@mclink.it
Contact: Francesco Gaudio, MD +390633062615 f.pelliccia@mclink.it

Sponsors and Collaborators
University of Roma La Sapienza
Investigators
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Principal Investigator: Francesco Pelliccia, MD Sapienza University of Rome

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Francesco Pelliccia, Professor, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT03727958    
Other Study ID Numbers: 2018/D/789
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No