Technical and Translational Development of Cardiovascular MRI (CMR)
Overview
- Phase
- N/A
- Intervention
- Child Patient or Healthy Child
- Conditions
- Normal and Abnormal Cardiovascular Physiology
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
- Enrollment
- 5000
- Locations
- 1
- Primary Endpoint
- Translational development of MRI sequences
- Status
- Recruiting
- Last Updated
- 8 days ago
Overview
Brief Summary
Background:
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.
Objectives:
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.
Eligibility:
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
Design:
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.
...
Detailed Description
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 postprocessing 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •INCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:
- •Age greater than or equal to 7 years
- •Able to follow instructions and lie still in the MRI scanner
- •Currently without known cardiovascular disease
- •Able to provide informed consent in writing or provide guardian consent
- •Willingness to cooperate with all study procedures and available for scheduled study events
Exclusion Criteria
- •FOR HEALTHY VOLUNTEERS:
- •Important past or chronic medical illness such as major cardiovascular conditions like myocardial infarction, congenital heart disease, and known cardiomyopathy
- •Conditions that are thought to make MRI unsafe (that will be determined by filling out a separate form) including:
- •Cardiac pacemaker or implantable defibrillator unless it is labeled safe or conditional for MRI
- •Cerebral aneurysm clip unless it is labeled safe for MRI
- •Neural stimulator (e.g. TENS-Unit) unless it is labeled safe for MRI
- •Any type of ear or cochlear implant unless it is labeled safe for MRI
- •Ocular foreign body (e.g. metal shavings)
- •Metal shrapnel or bullet unless cleared by plain x-ray as safe for MRI
- •Any implanted device (e.g. insulin pump, drug infusion device), unless it is labeled safe or conditional for MRI
Arms & Interventions
Child Patient or Healthy Child
Healthy children will be used as controls for children with cardiac disease. Child patient will undergo MRI scans.
Assessing Gadolinium deposition within the brain in healthy and patient subjects
Both healthy subjects and patient subjects who have previously undergone MRI and received gadolinium.
Healthy Volunteers
Subjects may be used to test image quality or functionality of MRI sequences; subjects may also be used as controls for adults with cardiac and non-cardiac disease.
Research Patients Cardiac and Non Cardiac
Adults with risk factors for cardiac disease or suspected or known cardiac disease
Outcomes
Primary Outcomes
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.