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| ID | Type | Description | Link |
|---|---|---|---|
| 12-H-0141 |
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Title: Evaluating New Radiation Techniques for Cardiovascular Imaging
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:
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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Subjects with Clinical indication for a coronary CT angiography exam |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cannon Aquilion ONE CT system | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The purpose of this research study is to learn whether these new imaging methods are accurate or predict subject outcomes. | ongoing |
| Measure | Description | Time Frame |
|---|---|---|
| Compare and/or validate radiation saving techniques such as iterative reconstruction or artificial intelligence based methods against standard imaging techniques for calcium scoring. | The purpose of this research study is to learn whether these new imaging methods are accurate or predict subject outcomes. | ongoing |
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INCLUSION CRITERIA:
EXCLUSION CRITERIA:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Margaret C Lowery, R.N. | Contact | (301) 451-3128 | peg.lowery@nih.gov | |
| Marcus Y Chen, M.D. | Contact | (301) 496-0077 | chenmy@mail.nih.gov |
| Name | Affiliation | Role |
|---|---|---|
| Marcus Y Chen, M.D. | National Heart, Lung, and Blood Institute (NHLBI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center | Recruiting | Bethesda | Maryland | 20892 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37698922 | Derived | 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. | |
| 37471145 |
| Label | URL |
|---|---|
| NIH Clinical Center Detailed Web Page | View source |
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| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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|
| 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. |
The purpose of this research study is to learn whether these new imaging methods are accurate or predict subject outcomes. |
| ongoing |
| Estimate diagnostic accuracy of cardiovascular evaluations using current CT technology vs. invasive angiography reports/images and vs. stress perfusion MRI reports/images. | The purpose of this research study is to learn whether these new imaging methods are accurate or predict subject outcomes. | ongoing |
| Evaluate image quality from new CT technology. | The purpose of this research study is to learn whether these new imaging methods are accurate or predict subject outcomes. | ongoing |
| Survival analysis of subjects identified by CT with significant coronary artery disease (=50% stenosis) vs. subjects without significant coronary artery disease (<50% stenosis). | The purpose of this research study is to learn whether these new imaging methods are accurate or predict subject outcomes. | ongoing |
| Estimate radiation dose from clinically performed cardiovascular CT at the NIH compared to outside clinically indicated CTs. | The purpose of this research study is to learn whether these new imaging methods are accurate or predict subject outcomes. | ongoing |
| Derived |
| 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. |
| 35389891 | Derived | 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. |
| 27591767 | Derived | 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. |