Technical and Translational Development of Cardiovascular Magnetic Resonance (CMR) Imaging
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|ClinicalTrials.gov Identifier: NCT03581318|
Recruitment Status : Recruiting
First Posted : July 10, 2018
Last Update Posted : May 19, 2022
Magnetic resonance imaging (MRI) is an important non-invasive tool to study and diagnose cardiovascular disease. MRI scanners use strong magnetic fields and radio waves to create pictures of body organs. Researchers want to find better MRI methods and new ways of imaging cardiovascular disease and better understand normal and abnormal cardiovascular and brain function. Researchers are also interested in seeing if gadolinium, the commonly used MRI contrast agent, stays in the body long after the MRI was performed.
To develop new methods for imaging the heart and other organs of the body.
To describe cardiovascular diseases using newer MRI methods
To look at the relationship between cardiovascular disease and cardiovascular risk factors and other organ systems
To look for gadolinium deposits in the brain from prior exams.
Healthy people and people with known or suspected cardiovascular disease ages 7 and older may be eligible for this study.
Researchers may be particularly interested in those who:
- Have suspected or known cardiovascular disease
- Were previously exposed to a gadolinium-based contrast agent,
- Need to have a heart MRI scheduled
- Need a test of the heart or other body part or will be undergoing a future cardiac catheterization
There are multiple arms to the study with optional components; therefore, there are multiple variations as to what an individual participant s experience may involve.
Participants will have an MRI scan lasting up to 2 hours. The scanner is a large hollow tube. During the scan, there may be loud knocking and buzzing sounds caused by the scanner. Participants will lie on a table that slides in and out of the tube. Their vital signs may be monitored.
Participants may have a test of heart electrical activity using wires connected to pads on the skin.
Participants may have blood drawn.
Participants may be injected with an MRI contrast agent through a plastic tube inserted in the arm.
|Condition or disease||Intervention/treatment||Phase|
|Normal and Abnormal Cardiovascular Physiology||Device: MRI||Not Applicable|
The purpose of this protocol is to develop and test new MRI techniques applicable to patients undergoing cardiovascular evaluation with the ultimate goal of translating the technical advances into improving clinical diagnosis and management of patients undergoing cardiovascular evaluation. Patients undergoing cardiovascular evaluation and healthy volunteers will be scanned under the protocol. We will evaluate new developments in non-contrast and contrast MRI of the heart and blood vessels and novel post-processing methods.
The use of the newer sequences will be used to improve clinical imaging workflow and disease diagnosis. We hope to use this protocol to clearly describe cardiovascular disease and associated problems using novel MRI methods and follow certain subsets of patients with disease as part of a natural history process. Inter-related physiologic systems may be phenotyped by MRI with characterization of disease associations between different organ systems.
Additionally, information regarding gadolinium deposition of the brain will be gathered. The literature regarding deposition of gadolinium in the brain has a large void regarding information of prevalence of the phenomenon in healthy subjects. The National Institutes of Health has a large healthy subject pool who have participated in gadolinium contrast MRI studies. This pool of healthy subjects is not easily available at most clinical MRI centers, and thus, we are uniquely well-situated to be able to answer this outstanding question.
For all objectives, MRI studies will be conducted in the NIH MRI systems located at the NIH Clinical Center in Bethesda, Maryland. These procedures may involve the intravenous administration of commercially available MR contrast media and exercise or pharmacologic stress testing. Results will be used to evaluate the performance of various research pulse sequences, gradient coils, and radiofrequency receiver coils on human subjects and will provide essential ground work for specific patient protocols, both diagnostic and therapeutic.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||5000 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Technical and Translational Development of Cardiovascular MRI (CMR)|
|Actual Study Start Date :||July 12, 2018|
|Estimated Primary Completion Date :||April 1, 2028|
|Estimated Study Completion Date :||April 1, 2028|
MRI for up to two hours, some without- and some with- administration of intravenous gadolinium based contrast agents (GBCAs), as well as some without and some with pharmacologic or physical stress.
- Translational development of MRI sequences [ Time Frame: on going ]Possible comparison to other studies that subjects may have undergone. Descriptive MRI catalogue of multiple cardiovascular processes Follow-up of outcomes subsequent to the MRI scan in select subject groups Follow-up of changes in diagnosis following the MRI scan in select subject groups
- Technical development of MRI sequences [ Time Frame: on going ]Possible assessments include structure depictions, heart chamber volumes, blood flow velocity, image quality scores, pixelwise and segmental summary scores of parametric maps in the heart. Anatomical imaging may be assessed for non- cardiac applications. Contrast- to-noise, and signal-to-noise measurements may be performed. For novel sequences, comparisons to standard product sequences may be performed.
- Evaluating the correlation [ Time Frame: on going ]Measurements of cardiac chamber size and function, vascular reactivity and perfusion are among the parameters that may be followed with comparison to standard biomarkers of disease and clinical manifestations of disease. Neurologic vascular reactivity, blood volume, resting state connectivity, BOLD signal changes may be compared among healthy subjects, asymptomatic subjects with risk factors, and subjects with disease.
- Assesment of Gad deposition in the brain [ Time Frame: on going ]Assessment of non-contrast MRI findings that are consistent with gadolinium deposition.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03581318
|Contact: Jennifer L Henry, R.N.||(301) firstname.lastname@example.org|
|Contact: Marcus Y Chen, M.D.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Marcus Y Chen, M.D.||National Heart, Lung, and Blood Institute (NHLBI)|