New MRI study aims to sharpen heart imaging and check for gadolinium traces
NCT ID NCT03581318
First seen Jun 27, 2026 · Last updated Sep 09, 2026 · Updated 9 times
Summary
This study aims to develop better MRI methods for imaging the heart and brain, and to describe heart diseases using these new techniques. It will also investigate whether gadolinium, a common MRI contrast agent, stays in the body long after use. Up to 5,000 healthy volunteers and people with known or suspected heart disease, ages 7 and older, will participate. The study involves MRI scans, possible blood draws, and heart monitoring, but does not test a new treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 5,000 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2018
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Primary care clinic
- Ages
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7 to 100 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* 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 may still be included in the study but may not be exposed to gadolinium-based contrast agents * Pregnancy. When uncertain of pregnancy status, subjects will undergo serum or urine pregnancy testing within the 7 days prior to the examination. Among those subjects who will receive MRI contrast, subjects of child-bearing potential will under serum or urine pregnancy testing within 7 days of the day prior to examination. In addition, the subject will be asked if she may be pregnant prior to the performance of the MRI, even if the pregnancy test was negative within the past week. The pregnancy test will be repeated if she answers in the affirmative. Post-menopausal and surgically sterilized subjects are automatically exempt from this testing. * If receiving contrast, breast feeding women (unless subject is willing to discard breast milk for 24 hours) are excluded * Healthy volunteer children will not have contrast * In a year's time, healthy volunteers are not restricted as to the number of non-contrast MRI examinations they undergo, but they may not undergo more than two examinations involving gadolinium-based contrast agents (GBCA) and those exposures will be at least 18 hours (12 half-lives) apart. INCLUSION CRITERIA FOR SUBJECTS WITH KNOWN OR SUSPECTED WITH HEART DISEASE: * Age \>= 7 years * Subjects with known or suspected cardiovascular disease * Able to provide informed consent in writing or provide guardian consent * Willingness to cooperate with all study procedures (including food restriction) and available for scheduled study events EXCLUSION CRITERIA FOR SUBJECTS WITH KNOWN OR SUSPECTED HEART DISEASE: * 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 * Pregnancy. When uncertain of pregnancy status, subjects will undergo serum or urine pregnancy testing within the 7 days prior to the examination. Among those subjects who will receive MRI contrast, subjects of child-bearing potential will undergo serum or urine pregnancy testing 7 days prior to examination. In addition, the subject will be asked if she may be pregnant prior to the performance of the MRI, even if the pregnancy test was negative within the past week. The pregnancy test will be repeated if she answers in the affirmative. Post-menopausal and surgically sterilized subjects are automatically exempt from this testing. * Breast feeding (unless subject is willing to discard breast milk for 24 hours if receiving contrast) * eGFR \< 30 mL/min/1.73m\^2 using the 2021 CKD-EPI equation or Community Practice Standard for Pediatric case or equivalent and a serum creatinine measured within 2 weeks without intercurrent change in medical condition or medications. Subjects meeting this exclusion criterion may still be included in the study but may not be exposed to gadolinium-based contrast agents * Cardiorespiratory instability as determined by the enrolling clinician INCLUSION CRITERIA FOR SUBJECTS WITH NON-CARDIAC DISEASE: * Age \>= 7 years * Able to provide informed consent in writing or provide guardian consent * Willingness to cooperate with all study procedures (including food restriction) and available for scheduled study events * Known or suspected brain, hematology, oncology, endocrine, pulmonary, or other non-cardiac disease. EXCLUSION CRITERIA FOR SUBJECTS WITH NON- CARDIAC DISEASE: * Conditions that are thought to make MRI unsafe (that will be determined by filling out a separate screening 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 * Pregnancy. When uncertain of pregnancy status, subjects will undergo serum or urine pregnancy testing within the 7 days prior to the examination. Among those subjects who will receive MRI contrast, subjects of child-bearing potential will undergo serum or urine pregnancy testing on the day of the examination. In addition, the subject will be asked if she may be pregnant prior to the performance of the MRI, even if the pregnancy test was negative within the past week. The pregnancy test will be repeated if she answers in the affirmative. Post-menopausal and surgically sterilized subjects are automatically exempt from this testing. * Breast feeding in those subjects receiving contrast (unless subject is willing to discard breast milk for 24 hours * eGFR \< 30 mL/min/1.73m\^2 using the 2021 CKD-EPI equation or equivalent and a serum creatinine measured within 2 weeks without intercurrent change in medical condition or medications. Subjects meeting this exclusion criterion may still be included in the study but may not be exposed to gadolinium-based contrast agents * Cardiorespiratory instability or as determined by the enrolling clinician
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
RECRUITINGBethesda, Maryland, 20892, United States
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