HealthyNCT01399385
New Heart Imaging Techniques to Evaluate Possible Heart Disease
A study testing MR Imaging Techniques - 1, MR Imaging Techniques - 2 and MR Imaging Techniques - 3 in people with Healthy and Obesity, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- What is being tested?
- MR Imaging Techniques - 1, MR Imaging Techniques - 2 and MR Imaging Techniques - 3
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,000 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jul 2011to 5 Nov 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects with or without history of cardiovascular diseases and with various degrees of cardiovascular risk factor. Subjects with known or suspected atherosclerotic disease based on clinical findings or documented by angiography (conventional, CTA or MRA), or Doppler ultrasound. And, healthy volunteers and subjects with known or suspected diseases affecting the thoracic organs, abdominal organs, and other organs affected by metabolic diseases such as body fat and muscles. Subjects at risk for atherosclerosis including: smoking, obesity, hyperlipidemia, low levels of high density lipoproteins (<50 mg/dl for women and <40 mg/dl for men), hypertension, family history (early onset atherosclerosis <55 year old in male and < 65 year old in female who is first degree relative), and diabetes mellitus or metabolic syndrome.
- Subject must be willing to participate in the protocol.
- Subject age greater than 18 years old.
- Subject must be able to provide informed consent.
- Subject must be clinically stable and be able to come to the Clinical Center to participate in the study.
Who cannot join
- Subjects with contraindication to MRI scanning. These contraindications include but are not limited to the following devices or conditions:
- Implanted cardiac pacemaker or defibrillator
- Cochlear Implants
- Ocular foreign body (e.g. metal shavings)
- Embedded shrapnel fragments
- Central nervous system aneurysm clips
Show all 44Show fewer
- Implanted neural stimulator
- Medical infusion pumps
- Any implanted device that is incompatible with MRI.
- 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.
- History of allergic reaction to gadolinium contrast agents despite the use of premeditation with an anti-histaminic and cortisone.
- eGFR < 60 ml/min/1.73m^2
- Contraindication to the use of CTA contrast agents:
- Creatinine value > 1.4 mg/dl
- History of multiple myeloma
- Use of metformin-containing products less than 24 hrs prior to contrast administration
- History of allergic reaction to CTA contrast agents despite the use of pre- medication with an anti-histaminic and cortisone.
- Subjects with contraindication precluding the use of beta blockers necessary to perform the coronary CTA. These include:
- Asthma
- Active bronchospasm
- Moderate or severe COPD
- 2nd or 3rd degree AV block
- Decompensated cardiac failure
- Allergy to beta blockers
- Systolic blood pressure < 100 mm Hg
- Pregnancy or nursing
- Subjects reporting a history of the following conditions will be excluded:
- Severe aortic stenosis
- Hypertrophic cardiomyopathy
- Inferior myocardial infarction with right ventricular involvement
- Cardiac tamponade
- Constrictive pericarditis
- Severe hypotension (systolic BP <90 mmHg)
- Uncorrected hypovolemia
- Raised intracranial pressure
- Glaucoma
- Severe anemia
- Concomitant use of phosphodiesterase-5 inhibitors (sildenafil-Viagra, tadalifil-Cialis, verdenafil-Levitra)
- History of hypersensitivity to nitroglycerin
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Magnetic Resonance of Body, Arterial Wall, and Angiography Imaging for Non- Invasive Assessment of Arterial Distensibility, Endothelial Dysfunction and Atherosclerotic Disease Using 1.5T and High Field (3T) MRI: A Technical Development Study of Cardiac and Body Imaging
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.
Read more
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:
- Participants will be screened with a physical exam, medical history, and blood tests.
- They will have an angiography to study the inside of blood vessels. This test is an x-ray study of the blood vessels. It will be done either separately or as part of a set of tests to diagnose possible heart disease.
- Participants will have at least one and up to five MRI scans. The scans will involve different methods of studying the heart and blood vessels. Participants may also have a computed tomography scan to confirm the findings of an MRI scan.
- No treatment will be provided as part of this protocol.
Read the detailed description
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.
- Conditions
- Healthy, Obesity, Diabetes, Healthy Volunteers, Atherosclerosis
- Being tested
- MR Imaging Techniques - 1, MR Imaging Techniques - 2, MR Imaging Techniques - 3, MR Imaging Techniques - 4
- Keywords
- Distensibility Imaging, Arteriosclerosis, Narrowing of Vessels, Endothelial Dysfunction, Hardening of the arteries, Non-Invasive Plaque Imaging, Cardiovascular Disease, Heart Disease, Arteriosclerosis, Healthy Volunteer, HV
- Medical subject headings
- Obesity, Diabetes Mellitus, Atherosclerosis, Arteriosclerosis, Cardiovascular Diseases, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR Imaging Techniques - 1Device
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
MR Imaging Techniques - 2Device
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 - 3Device
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 - 4Device
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: MR Imaging Techniques - 1 |
| 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 Receives: Device: MR Imaging Techniques - 2 |
| 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 Receives: Device: MR Imaging Techniques - 3 |
| 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 Receives: Device: MR Imaging Techniques - 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: within one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2011 (estimated)
- Study start6 Jul 2011
- Primary completion6 Nov 2028 (estimated)
- Study completion5 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Ahmed M Gharib, M.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01399385
- Sponsor's protocol ID
- 110168
- Other IDs
- 11-DK-0168
- Status last verified
- 5 Oct 2026
- First submitted
- 20 Jul 2011
- Last updated
- 7 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 11684624Bradbury 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.
PubMed 1175657Lopez 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.
PubMed 9809543Abd-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.
PubMed 39069898Abd-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.
PubMed 38573125Nazari 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.
PubMed 36538160Ouwerkerk 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.
PubMed 33724063Muniyappa 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.
PubMed 29617001Neary 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.
PubMed 23559084
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance of Body, Arterial Wall, and Angiography Imaging for Non- Invasive Assessment of Arterial Distensibility, Endothelial Dysfunction and Atherosclerotic Disease Using 1.5T and High Field (3T) MRI: A Technical Development Study of Cardiac and Body Imaging
- ClinicalTrials.gov ID
- NCT01399385
- Acronym / sponsor ID
- 110168
- Conditions
- Healthy, Obesity, Diabetes, Healthy Volunteers, Atherosclerosis
- Keywords
- Distensibility Imaging, Arteriosclerosis, Narrowing of Vessels, Endothelial Dysfunction, Hardening of the arteries, Non-Invasive Plaque Imaging, Cardiovascular Disease, Heart Disease, Arteriosclerosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 6 Jul 2011 (actual)
- Primary completion
- 6 Nov 2028 (estimated)
- Study completion
- 5 Nov 2030 (estimated)
- First posted
- 21 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Participants will be screened with a physical exam, medical history, and blood tests.
- They will have an angiography to study the inside of blood vessels. This test is an x-ray study of the blood vessels. It will be done either separately or as part of a set of tests to diagnose possible heart disease.
- Participants will have at least one and up to five MRI scans. The scans will involve different methods of studying the heart and blood vessels. Participants may also have a computed tomography scan to confirm the findings of an MRI scan.
- No treatment will be provided as part of this protocol.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: MR Imaging Techniques - 1Group 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 | Device: MR Imaging Techniques - 2Group 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 | Device: MR Imaging Techniques - 3Group 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 | Device: MR Imaging Techniques - 4Group 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 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
Key exclusion criteria (44 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MR Imaging Techniques - 1Group 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 | Device | Group 1 |
| MR Imaging Techniques - 2Group 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 | Device | Group 2 |
| MR Imaging Techniques - 3Group 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 | Device | Group 3 |
| MR Imaging Techniques - 4Group 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 | Device | Group 4 |
Primary outcome
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@...
Time frame: within one month
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
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
Time frame: within one month
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.
To develop, implement, and optimize new non-invasive methods for characterization of the micro-environment in the thoracic and abdominal area utilizing specialized techniques
Time frame: 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 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Background: PubMed 11684624Zheng 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.
- Background: PubMed 1175657Bradbury 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.
- Background: PubMed 9809543Lopez 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.
- Derived from this study: PubMed 39069898Abd-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.
- Derived from this study: PubMed 38573125Abd-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.
- Derived from this study: PubMed 36538160Nazari 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.
- Derived from this study: PubMed 33724063Ouwerkerk 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.
- Derived from this study: PubMed 29617001Muniyappa 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.
- Derived from this study: PubMed 23559084Neary 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.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ahmed M Gharib, M.D. principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MR Imaging Techniques - 1, MR Imaging Techniques - 2 and MR Imaging Techniques - 3 in people with Healthy and Obesity, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 44 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jatin R Matta, P.A.-C ((301) 443-8373, mattaj@mail.nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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@... (time frame: within one month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01399385, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.