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Observational Study of Cardiovascular MRI Development

This study aims to improve how we use Magnetic Resonance Imaging (MRI) to understand and diagnose heart and blood vessel conditions. Researchers want to develop better MRI methods and new ways to image the cardiovascular system, as well as learn more about how normal and abnormal hearts and brains function. They are also looking into whether gadolinium, a common MRI contrast agent, stays in the body long-term. You might be able to join if you are between 7 and 100 years old, can follow instructions, and don't have known heart disease. The study is looking for 5000 participants to help develop these new MRI techniques and improve patient care.

Study design
This is an observational study planning to enroll 5000 participants, including both healthy volunteers and patients undergoing cardiovascular evaluation.
What's involved
You would need to be able to follow instructions and lie still in the MRI scanner. You must also be willing to cooperate with all study procedures and be available for scheduled study events.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints, such as the development of MRI sequences and evaluating correlations, are measured on an ongoing basis.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03581318

Technical and Translational Development of Cardiovascular Magnetic Resonance (CMR) Imaging

Recruiting
Not specifiedAges 7+Observational
National Heart, Lung, and Blood Institute (NHLBI)
~5,000 participants
Updated 2026-08-21 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Translational development of MRI sequences
Measured over on going
+3 more outcomes measured

Conditions

Normal and Abnormal Cardiovascular Physiology

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Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • W. Patricia Bandettini, M.D. · PRINCIPAL_INVESTIGATOR · National Heart, Lung, and Blood Institute (NHLBI)

Who to contact

Jennifer L Henry, R.N.
[email protected]
(301) 827-6720
Email the study team

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Eligibility criteria

Inclusion

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
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
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

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.
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
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
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

What this trial measures

  • Translational development of MRI sequenceson 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 sequenceson 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 correlationon 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 brainon going

    Assessment of non-contrast MRI findings that are consistent with gadolinium deposition.