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| ID | Type | Description | Link |
|---|---|---|---|
| 11-DK-0168 |
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Background:
- Imaging tests, such as magnetic resonance imaging (MRI), can provide information about heart and blood vessels. The tests let doctors can see the amount of blood vessel narrowing and vessel wall thickness. This information may help diagnose and treat heart disease and other conditions that lead to heart attacks. Better MRI methods are needed to improve heart disease diagnosis, especially by avoiding the use of radiation. Researchers are testing new techniques to improve the quality of heart MRI, compared with more complex studies like catheterization or angiography.
Objectives:
- To compare heart MRI techniques with other tests used to diagnose heart disease.
Eligibility:
- People at least 18 years of age who either have or may have heart disease, or are healthy volunteers.
Design:
Specialized imaging techniques now available allow a unique opportunity to characterize the micro-environment of the human body. Magnetic Resonance (MR) vascular wall imaging and angiography (MRA) are developing techniques that permit non-invasive evaluation of arterial and venous structures without the need for x-ray based catheter angiography. In addition, vessel wall imaging provides unprecedented non-invasive tools to assess vascular endothelial function. While dramatic progress has been made to cardiovascular MR imaging in the last few years, there are still substantial limitations in the resolution, accuracy, and reproducibility of MRA and wall imaging in the comprehensive structural and functional evaluation of coronary artery. The first aim of this study is to develop and optimize clinical imaging protocols and techniques for fast high-resolution coronary MRA and wall imaging for the assessment of coronary and other main arteries structural, distensibility, and endothelial functional parameters. Technique optimization and performance evaluation will be accomplished in normal subjects without known or suspected coronary atherosclerosis. The second aim of this protocol is to evaluate early MR imagery signs of arterial structural, distensibility, and endothelial functional disorders associated with atherosclerosis in a cohort of patients with known or suspected coronary atherosclerosis. Results from accelerated high-resolution MRA will be correlated with corresponding Computerized Tomography Coronary Angiogram (CTA) results. The third aim of this protocol is to develop, implement, and optimize new non-invasive methods for characterization of the micro-environment in the thoracic and abdominal area utilizing specialized techniques such as MR Spectroscopy, MR Elastography, and blood oxygenation level dependent (BOLD) imaging. The long-term objective of this study and research initiative is to optimize coronary MRA, wall, and body imaging techniques to the point that it can reliably be used for routine prevention and assessment of early atherosclerosis and other diseases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Group 1 will consist of subjects with a 10-year total CHD risk <10% (low)They will undergo a series of multiple small discovery studies in order to look at the multiple different MR methods of visualizing the coronary arteries |
|
| Group 2 | Experimental | Group 2 will consist of subjects with a 10-year total CHD risk 10-20% (intermediate)They will undergo a series of multiple small discovery studies in order to look at the multiple different MR methods of visualizing the coronary arteries |
|
| Group 3 | Experimental | Group 3 will consist of subjects with a 10-year total CHD risk >20% (high)They will undergo a series of multiple small discovery studies in order to look at the multiple different MR methods of visualizing the coronary arteries |
|
| Group 4 | Experimental | Group 4 no known risk factors (control subjects)They will undergo a series of multiple small discovery studies in order to look at the multiple different MR methods of visualizing the coronary arteries |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MR Imaging Techniques - 1 | Device | Group 1 will consist of subjects with a 10-year total CHD risk <10% (low)They will undergo a series of multiple small discovery studies in order to look at the multiple different MR methods of visualizing the coronary arteries |
| Measure | Description | Time Frame |
|---|---|---|
| To develop and optimize clinical imaging protocols and techniques for fast high- resolution coronary MRA and wall imaging for the assessment of coronary and other main arteries structural distensibility, and endothelial functional parameters@... | The accelerated High-resolution MRA results will be compared to conventional angiography and/or computerized tomography angiography (CTA). High- resolution lumen dimensions will be compared to black- blood lumen measurements as well. It is expected that the MRA findings from the 3T scanner will demonstrate image quality that is nearly equivalent to the quality of the coronary arteries visualized using CTA and/or conventional coronary catheterization. Three- dimensional arterial dilatation mapping, representing endothelial function status, will be rendered and visualized | within one month |
| To evaluate early MR imagery signs of arterial structural, distensibility, and endothelial functional disorders associated with atherosclerosis in a cohort of patients with known or suspected coronary atherosclerosis | It is expected that the evaluation of the relationship among these risk factor and imaging variables will find relationships that can be further explored. This study is expected to find information in the data analysis that can be used to generate hypotheses for future testing. | within one month |
| To develop, implement, and optimize new non-invasive methods for characterization of the micro-environment in the thoracic and abdominal area utilizing specialized techniques | to develop, implement, and optimize new non-invasive methods for characterization of the micro-environment in the thoracic and abdominal area utilizing specialized techniques such as MR Spectroscopy, MR Elastography, and blood oxygenation level dependent (BOLD) imagingThe MRS, MRE and BOLD and other sequences results will be compared to conventional biopsy. It is expected that these advanced sequences will enable non-invasive evaluation and better understanding of various disease processes. | within one month |
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INCLUSION:
EXCLUSION CRITERIA:
Subjects with contraindication to MRI scanning. These contraindications include but are not limited to the following devices or conditions:
Unsatisfactory performance status as judged by the referring physician such that the subject could not tolerate an MRI scan. Examples of medical conditions that would not be accepted would include unstable angina and dyspnea at rest.
Subjects requiring sedation for MRI studies.
Subjects with a condition precluding entry into the scanner (e.g. morbid obesity, claustrophobia, etc.).
Pregnant or lactating women.
Subjects with severe back-pain or motion disorders who will be unable to tolerate supine positioning within the MRI scanner and hold still for the duration of the examination.
Subjects who are unable to undergo a CTA within 2 months of the MRA part of this study, or are unable to undergo or be scheduled for a cardiac catheterization within 2 months of the MRA.
EXCLUSION CRITERIA - FOR GADOLINIUM BASED MRI STUDIES ONLY:
EXCLUSION CRITERIA - FOR CORONARY CTA:
Contraindication to the use of CTA contrast agents:
Subjects with contraindication precluding the use of beta blockers necessary to perform the coronary CTA. These include:
EXCLUSION CRITERIA - FOR NITROGLYCERIN USE:
Subjects reporting a history of the following conditions will be excluded:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jatin R Matta, P.A.-C | Contact | (301) 443-8373 | mattaj@mail.nih.gov | |
| Ahmed M Gharib, M.D. | Contact | (301) 402-5744 | agharib@mail.nih.gov |
| Name | Affiliation | Role |
|---|---|---|
| Ahmed M Gharib, M.D. | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | 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 |
|---|---|---|---|
| 11684624 | Background | Zheng ZJ, Croft JB, Giles WH, Mensah GA. Sudden cardiac death in the United States, 1989 to 1998. Circulation. 2001 Oct 30;104(18):2158-63. doi: 10.1161/hc4301.098254. | |
| 1175657 | Background | Bradbury EM, Chapman GE, Danby SE, Hartman PG, Riches PL. Studies on the role and mode of operation of the very-lysine-rich histone H1 (F1) in eukaryote chromatin. The properties of the N-terminal and C-terminal halves of histone H1. Eur J Biochem. 1975 Sep 15;57(2):521-8. doi: 10.1111/j.1432-1033.1975.tb02327.x. |
| Label | URL |
|---|---|
| NIH Clinical Center Detailed Web Page | View source |
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| MR Imaging Techniques - 2 | Device | Group 2 will consist of subjects with a 10-year total CHD risk 10-20% (intermediate)They will undergo a series of multiple small discovery studies in order to look at the multiple different MR methods of visualizing the coronary arteries |
|
| MR Imaging Techniques - 3 | Device | Group 3 will consist of subjects with a 10-year total CHD risk >20% (high)They will undergo a series of multiple small discovery studies in order to look at the multiple different MR methods of visualizing the coronary arteries |
|
| MR Imaging Techniques - 4 | Device | Group 4 no known risk factors (control subjects)They will undergo a series of multiple small discovery studies in order to look at the multiple different MR methods of visualizing the coronary arteries |
|
| 9809543 | Background | Lopez AD, Murray CC. The global burden of disease, 1990-2020. Nat Med. 1998 Nov;4(11):1241-3. doi: 10.1038/3218. No abstract available. |
| 39069898 | Derived | Abd-Elmoniem KZ, Edwan JH, Dietsche KB, Villalobos-Perez A, Shams N, Matta J, Baumgarten L, Qaddumi WN, Dixon SA, Chowdhury A, Stagliano M, Mabundo L, Wentzel A, Hadigan C, Gharib AM, Chung ST. Endothelial Dysfunction in Youth-Onset Type 2 Diabetes: A Clinical Translational Study. Circ Res. 2024 Aug 30;135(6):639-650. doi: 10.1161/CIRCRESAHA.124.324272. Epub 2024 Jul 29. |
| 38573125 | Derived | Abd-Elmoniem KZ, Ishaq H, Purdy J, Matta J, Hamimi A, Hannoush H, Hadigan C, Gharib AM. Association of Coronary Wall Thickening and Diminished Diastolic Function in Asymptomatic, Low Cardiovascular Disease-Risk Persons Living with HIV. Radiol Cardiothorac Imaging. 2024 Apr;6(2):e230102. doi: 10.1148/ryct.230102. |
| 36538160 | Derived | Nazari MA, Abd-Elmoniem KZ, Jha A, Matta J, Talvacchio S, Charles K, Feeley J, Patel M, Feelders R, Pacak K, Gharib AM. Reduced coronary artery luminal area in pheochromocytoma and paraganglioma patients. J Endocrinol Invest. 2023 Jul;46(7):1483-1487. doi: 10.1007/s40618-022-01982-5. Epub 2022 Dec 20. No abstract available. |
| 33724063 | Derived | Ouwerkerk R, Hamimi A, Matta J, Abd-Elmoniem KZ, Eary JF, Abdul Sater Z, Chen KY, Cypess AM, Gharib AM. Proton MR Spectroscopy Measurements of White and Brown Adipose Tissue in Healthy Humans: Relaxation Parameters and Unsaturated Fatty Acids. Radiology. 2021 May;299(2):396-406. doi: 10.1148/radiol.2021202676. Epub 2021 Mar 16. |
| 29617001 | Derived | Muniyappa R, Noureldin RA, Abd-Elmoniem KZ, El Khouli RH, Matta JR, Hamimi A, Ranganath S, Hadigan C, Nieman LK, Gharib AM. Personalized Statin Therapy and Coronary Atherosclerotic Plaque Burden in Asymptomatic Low/Intermediate-Risk Individuals. Cardiorenal Med. 2018;8(2):140-150. doi: 10.1159/000487205. Epub 2018 Mar 26. |
| 23559084 | Derived | Neary NM, Booker OJ, Abel BS, Matta JR, Muldoon N, Sinaii N, Pettigrew RI, Nieman LK, Gharib AM. Hypercortisolism is associated with increased coronary arterial atherosclerosis: analysis of noninvasive coronary angiography using multidetector computerized tomography. J Clin Endocrinol Metab. 2013 May;98(5):2045-52. doi: 10.1210/jc.2012-3754. Epub 2013 Apr 4. |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D003920 | Diabetes Mellitus |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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