Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2026-06-17 @ 7:47 PM
Study NCT ID:
NCT03727958
Status:
UNKNOWN
Last Update Posted:
2018-11-01
First Post:
2018-10-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Simultaneous Coronary Artery Evaluation and Lung Cancer CT Screening
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-31', 'studyFirstSubmitDate': '2018-10-28', 'studyFirstSubmitQcDate': '2018-10-31', 'lastUpdatePostDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety of computed tomography as measured by effective radiation dose (as measured in mSv)', 'timeFrame': 'Through study completion, an average of 2 months', 'description': 'Measurement of the effective radiation dose (as measured in mSv) at time of computed tomography'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HEAVY SMOKING']}, 'referencesModule': {'references': [{'pmid': '31554878', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptomatic subjects with effort-induced or typical chest pain\n* High probability of coronary artery disease\n* Known coronary artery disease\n* Willing to participate to the study\n* Informed consent to undergo CT scan\n\nExclusion Criteria:\n\n* Contraindications to iodinated contrast such as allergies and chronic kidney failure\n* Any suspicion of pregnancy'}, 'identificationModule': {'nctId': 'NCT03727958', 'acronym': 'SIMULTANEOUS', 'briefTitle': 'Simultaneous Coronary Artery Evaluation and Lung Cancer CT Screening', 'organization': {'class': 'OTHER', 'fullName': 'University of Roma La Sapienza'}, 'officialTitle': 'Simultaneous Coronary Artery Evaluation and Lung Cancer Screening With a New Ultrafast-low-dose Computed Tomography Protocol: A Pilot Randomized Trial', 'orgStudyIdInfo': {'id': '2018/D/789'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lung and coronary CT assessment', 'description': 'Subjects will undergo simultaneous CT assessment of both coronary arteries and thoracic area', 'interventionNames': ['Diagnostic Test: Lung and coronary CT assessment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Coronary CT assessment', 'description': 'Subjects will undergo CT assessment of coronary arteries only', 'interventionNames': ['Diagnostic Test: Coronary CT assessment']}], 'interventions': [{'name': 'Lung and coronary CT assessment', 'type': 'DIAGNOSTIC_TEST', 'description': 'Subjects will undergo simultaneous coronary arteries and thoracic CT assessment', 'armGroupLabels': ['Lung and coronary CT assessment']}, {'name': 'Coronary CT assessment', 'type': 'DIAGNOSTIC_TEST', 'description': 'Subjects will undergo coronary arteries CT assessment only', 'armGroupLabels': ['Coronary CT assessment']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Francesco Pelliccia, MD', 'role': 'CONTACT', 'email': 'f.pelliccia@mclink.it', 'phone': '+390633062615'}, {'name': 'Francesco Gaudio, MD', 'role': 'CONTACT', 'email': 'f.pelliccia@mclink.it', 'phone': '+390633062615'}], 'overallOfficials': [{'name': 'Francesco Pelliccia, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Roma La Sapienza'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Roma La Sapienza', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Francesco Pelliccia', 'investigatorAffiliation': 'University of Roma La Sapienza'}}}}