Technical and Translational Development of Cardiovascular Magnetic Resonance (CMR) Imaging (NCT03581318) | Clinical Trial Compass
RecruitingNot Applicable
Technical and Translational Development of Cardiovascular Magnetic Resonance (CMR) Imaging
United States5,000 participantsStarted 2018-07-12
Plain-language 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.
Who can participate
Age range
7 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* INCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:
* 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
* 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
* eGFR \< 60 mL/min/1.73m\^2 using the 2021 CKD-EPI equation or equivalent (using the CRIScalculated eGFR to define the threshold) and a serum creatinine measured within 2 weeks without intercurrent change in medical condition or medications. Subjects meeting this exclusion criterion …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Translational development of MRI sequences
Timeframe: on going
2
Technical development of MRI sequences
Timeframe: on going
3
Evaluating the correlation
Timeframe: on going
4
Assesment of Gad deposition in the brain
Timeframe: on going
Trial details
NCT IDNCT03581318
SponsorNational Heart, Lung, and Blood Institute (NHLBI)