Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-31 @ 8:01 PM
Study NCT ID:
NCT01621594
Status:
RECRUITING
Last Update Posted:
2025-12-17
First Post:
2012-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating New Radiation Techniques for Cardiovascular Imaging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003327', 'term': 'Coronary Disease'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-06-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12-12', 'completionDateStruct': {'date': '2027-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2012-06-14', 'studyFirstSubmitQcDate': '2012-06-14', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare time-to-first cardiovascular events (death, revascularization more than 90 days after CTA, hospitalization, non-fatal myocardial infarction, stroke) in subjects with >=50% coronary stenosis vs. <50% stenosis.', 'timeFrame': 'ongoing', 'description': 'The purpose of this research study is to learn whether these new imaging methods are accurate or predict subject outcomes.'}], 'secondaryOutcomes': [{'measure': 'Compare and/or validate radiation saving techniques such as iterative reconstruction or artificial intelligence based methods against standard imaging techniques for calcium scoring.', 'timeFrame': 'ongoing', 'description': 'The purpose of this research study is to learn whether these new imaging methods are accurate or predict subject outcomes.'}, {'measure': 'Evaluate natural history of coronary plaques in subjects with serial imaging if requested by ordering physician, or in subjects with >50% stenosis or high risk plaques on medical therapy.', 'timeFrame': 'ongoing', 'description': 'The purpose of this research study is to learn whether these new imaging methods are accurate or predict subject outcomes.'}, {'measure': 'Estimate diagnostic accuracy of cardiovascular evaluations using current CT technology vs. invasive angiography reports/images and vs. stress perfusion MRI reports/images.', 'timeFrame': 'ongoing', 'description': 'The purpose of this research study is to learn whether these new imaging methods are accurate or predict subject outcomes.'}, {'measure': 'Evaluate image quality from new CT technology.', 'timeFrame': 'ongoing', 'description': 'The purpose of this research study is to learn whether these new imaging methods are accurate or predict subject outcomes.'}, {'measure': 'Survival analysis of subjects identified by CT with significant coronary artery disease (=50% stenosis) vs. subjects without significant coronary artery disease (<50% stenosis).', 'timeFrame': 'ongoing', 'description': 'The purpose of this research study is to learn whether these new imaging methods are accurate or predict subject outcomes.'}, {'measure': 'Estimate radiation dose from clinically performed cardiovascular CT at the NIH compared to outside clinically indicated CTs.', 'timeFrame': 'ongoing', 'description': 'The purpose of this research study is to learn whether these new imaging methods are accurate or predict subject outcomes.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['computer tomography', 'Cardiac', 'Radiation Reduction', 'Iterative Reconstruction'], 'conditions': ['Coronary Disease']}, 'referencesModule': {'references': [{'pmid': '37698922', 'type': 'DERIVED', 'citation': 'Sorokin AV, Hong CG, Aponte AM, Florida EM, Tang J, Patel N, Baranova IN, Li H, Parel PM, Chen V, Wilson SR, Ongstad EL, Collen A, Playford MP, Eggerman TL, Chen MY, Kotani K, Bocharov AV, Remaley AT. Association of oxidized ApoB and oxidized ApoA-I with high-risk coronary plaque features in cardiovascular disease. JCI Insight. 2023 Oct 23;8(20):e172893. doi: 10.1172/jci.insight.172893.'}, {'pmid': '37471145', 'type': 'DERIVED', 'citation': 'Sato M, Neufeld EB, Playford MP, Lei Y, Sorokin AV, Aponte AM, Freeman LA, Gordon SM, Dey AK, Jeiran K, Hamasaki M, Sampson ML, Shamburek RD, Tang J, Chen MY, Kotani K, Anderson JL, Dullaart RP, Mehta NN, Tietge UJ, Remaley AT. Cell-free, high-density lipoprotein-specific phospholipid efflux assay predicts incident cardiovascular disease. J Clin Invest. 2023 Sep 15;133(18):e165370. doi: 10.1172/JCI165370.'}, {'pmid': '35389891', 'type': 'DERIVED', 'citation': 'Sorokin AV, Patel N, Abdelrahman KM, Ling C, Reimund M, Graziano G, Sampson M, Playford MP, Dey AK, Reddy A, Teague HL, Stagliano M, Amar M, Chen MY, Mehta NN, Remaley AT. Complex association of apolipoprotein E-containing HDL with coronary artery disease burden in cardiovascular disease. JCI Insight. 2022 May 23;7(10):e159577. doi: 10.1172/jci.insight.159577.'}, {'pmid': '27591767', 'type': 'DERIVED', 'citation': 'Choi AD, Leifer ES, Yu J, Shanbhag SM, Bronson K, Arai AE, Chen MY. Prospective evaluation of the influence of iterative reconstruction on the reproducibility of coronary calcium quantification in reduced radiation dose 320 detector row CT. J Cardiovasc Comput Tomogr. 2016 Sep-Oct;10(5):359-63. doi: 10.1016/j.jcct.2016.07.016. Epub 2016 Jul 27.'}], 'seeAlsoLinks': [{'url': 'https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2012-H-0141.html', 'label': 'NIH Clinical Center Detailed Web Page'}]}, 'descriptionModule': {'briefSummary': 'Title: Evaluating New Radiation Techniques for Cardiovascular Imaging\n\nBackground:\n\nCardiac CT angiography is associated with radiation exposure. Different methods of creating CT pictures have been developed to reduce the radiation dose to the subject. The purpose of this research study is to learn whether these low dose research imagings are accurate or predict subject outcomes.\n\nCardiac CT is also used for diagnostic imaging of coronary artery disease and identification of abnormal cardiac structures. An additional purpose of this study is to monitor the progression of cardiac disease.\n\nCardiac imaging software and AI are constantly evolving and requires validation for accuracy. Using existing scan data, updated image software reconstruction can be applied and compared to previous existing standard of care images.\n\nObjectives:\n\n\\- To study new ways of taking pictures of the heart or blood vessels using computed tomography.\n\nEligibility:\n\n\\- Adults at least 18 years of age who will be having imaging studies to help detect heart or blood vessel problems.\n\nDesign:\n\n* Participants will be screened with a physical exam and medical history. Blood samples will be taken to check kidney function.\n* Participants will have a CT scan of the heart and blood vessels. A contrast agent may be used to improve the quality of the images. The scanning session may last up to 2 hours.\n* Timing of and the need for follow up contact will depend on results from the initial scan and may be repeated to assess for late events. Telephone, office contact, or other follow-up of subjects may be done after CCTA to evaluate if the subject had subsequent cardiovascular testing. Further follow up will be based on reported test results.', 'detailedDescription': 'Cardiac CT angiography is associated with radiation exposure. Different methods of creating CT pictures have been developed to reduce the radiation dose to the subject. The purpose of this research study is to learn whether these low dose research imagings are accurate or predict subject outcomes.\n\nCardiac CT is also used for diagnostic imaging of coronary artery disease and identification of abnormal cardiac structures. An additional purpose of this study is to monitor the progression of cardiac disease.\n\nCardiac imaging software and Artificial Intelligence (AI) are constantly evolving and requires validation for accuracy. Using existing scan data, updated image software reconstruction can be applied and compared to previous existing standard of care images.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* INCLUSION CRITERIA:\n\n 1. Clinical indication for a coronary CT angiography exam\n 2. Age equal to or greater than 18 years\n 3. Able to understand and willing to sign the Informed Consent Form\n 4. Able and willing to provide follow-up information\n\nEXCLUSION CRITERIA:\n\n1. Pregnancy\n2. If receiving intravenous contrast, severe renal excretory dysfunction, estimated glomerular filtration rate \\< 30 mL/min/1.73m2 body surface area according to the Modification of Diet in Renal Disease criteria or as reported by the clinical lab. Glomerular filtration rate will be estimated using the 2021 CK-EPI equation that eliminate the use of race coefficient as reported in CRIS.\n\nScreen Failures: Subjects who are screen failures can be re-enrolled once they meet eligibility criteria. Rescreened participants will be assigned the same participant number as for the initial screening.'}, 'identificationModule': {'nctId': 'NCT01621594', 'briefTitle': 'Evaluating New Radiation Techniques for Cardiovascular Imaging', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'Prospective Evaluation of New Techniques in Radiation Reduction for Cardiovascular Computed Tomographic Angiography', 'orgStudyIdInfo': {'id': '120141'}, 'secondaryIdInfos': [{'id': '12-H-0141'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Subjects with Clinical indication for a coronary CT angiography exam', 'interventionNames': ['Device: Cannon Aquilion ONE CT system']}], 'interventions': [{'name': 'Cannon Aquilion ONE CT system', 'type': 'DEVICE', 'description': 'To test the diagnostic accuracy of low-radiation dose CT coronary angiography for detecting significant coronary artery stenosis and to determine the prognostic value of low-radiation dose CT coronary angiography for discriminating patient risk of death or major adverse cardiac events.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)', 'role': 'CONTACT', 'email': 'ccopr@nih.gov', 'phone': '800-411-1222', 'phoneExt': 'TTY dial 711'}], 'facility': 'National Institutes of Health Clinical Center', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}], 'centralContacts': [{'name': 'Margaret C Lowery, R.N.', 'role': 'CONTACT', 'email': 'peg.lowery@nih.gov', 'phone': '(301) 451-3128'}, {'name': 'Marcus Y Chen, M.D.', 'role': 'CONTACT', 'email': 'chenmy@mail.nih.gov', 'phone': '(301) 496-0077'}], 'overallOfficials': [{'name': 'Marcus Y Chen, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Heart, Lung, and Blood Institute (NHLBI)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}