Technical and Translational Development of Cardiovascular Magnetic Resonance (CMR) Imaging
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age7-100
SponsorNational Heart, Lung, and Blood Institute (NHLBI)
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age >= 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
Disqualifiers
Important past or chronic medical illness such as major cardiovascular conditions like myocardial infarction, congenital heart disease, and known cardiomyopathy
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
Trial population
Primary care clinic
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
5,000 Participants
are grouped into 4 trial groupsGroup A: Assessing Gadolinium deposition within the brain in healthy and patient subjects
Group B: Child Patient or Healthy Child
Group C: Healthy Volunteers
Group D: Research Patients Cardiac and Non Cardiac
Trial outcomes
Primary outcomes
1
Translational development of MRI sequences
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
Time frame
on going2
Technical development of MRI sequences
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.
Time frame
on going3
Evaluating the correlation
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.
Time frame
on going4
Assesment of Gad deposition in the brain
Assessment of non-contrast MRI findings that are consistent with gadolinium deposition.
Time frame
on goingSponsors and contacts
Click on the lead sponsor to view all of their trials.
National Heart, Lung, and Blood Institute (NHLBI)
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov