Evaluating New Radiation Techniques for Cardiovascular Imaging
NCT ID: NCT01621594
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
5000 participants
INTERVENTIONAL
2012-06-21
2027-04-01
Brief Summary
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Background:
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.
Cardiac 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.
Cardiac 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.
Objectives:
\- To study new ways of taking pictures of the heart or blood vessels using computed tomography.
Eligibility:
\- Adults at least 18 years of age who will be having imaging studies to help detect heart or blood vessel problems.
Design:
* Participants will be screened with a physical exam and medical history. Blood samples will be taken to check kidney function.
* 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.
* 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.
Detailed Description
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Cardiac 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.
Cardiac 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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1
Subjects with Clinical indication for a coronary CT angiography exam
Cannon Aquilion ONE CT system
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.
Interventions
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Cannon Aquilion ONE CT system
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.
Eligibility Criteria
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Inclusion Criteria
2. Age equal to or greater than 18 years
3. Able to understand and willing to sign the Informed Consent Form
4. Able and willing to provide follow-up information
Exclusion Criteria
2. 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.
Screen 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.
18 Years
100 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Responsible Party
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Principal Investigators
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Marcus Y Chen, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Heart, Lung, and Blood Institute (NHLBI)
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, United States
Countries
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Central Contacts
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Facility Contacts
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For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
Role: primary
References
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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.
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.
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.
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.
Related Links
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NIH Clinical Center Detailed Web Page
Other Identifiers
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12-H-0141
Identifier Type: -
Identifier Source: secondary_id
120141
Identifier Type: -
Identifier Source: org_study_id