Recruiting

Cardiovascular Imaging

Sponsor:

National Heart, Lung, and Blood Institute (NHLBI)

Code:

NCT03581318

Conditions

Normal and Abnormal Cardiovascular Physiology

Eligibility Criteria

Sex: All

Age: 7 - 70+

Healthy Volunteers: Accepted

Study Details

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.

Conditions

Normal and Abnormal Cardiovascular Physiology

Study ID

NCT03581318

Start date

Jul 12, 2018

Status verified date

Aug 14, 2026

Completion date

Apr 1, 2028

Anticipated

Primary completion date

Apr 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 70+

Healthy Volunteers: Accepted

  • 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

Study Design

Enrollment

5000 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Child Patient or Healthy Child

Healthy children will be used as controls for children with cardiac disease. Child patient will undergo MRI scans.

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

Primary outcome measure

  • Translational development of MRI sequences [ Time Frame: on going ]
  • Technical development of MRI sequences [ Time Frame: on going ]
  • Evaluating the correlation [ Time Frame: on going ]
  • Assesment of Gad deposition in the brain [ Time Frame: on going ]

Central Contacts and Locations

Central contacts

Jennifer L Henry, R.N.

(301) 827-6720henryjl@nhlbi.nih.gov

W. Patricia Bandettini, M.D.

(301) 451-3128ingkanisorn@nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

800-411-1222prpl@cc.nih.gov

More Information

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Last update posted

Sep 8, 2026

Last verified

Aug 14, 2026

Keywords

  • Congenital Heart Defects
  • Heart Valve Diseases
  • Chest pain (angina)
  • Heart Failure
  • Coronary Heart Disease
  • CABG
  • CARDIOMYOPATHY
  • Atherosclerosis
  • MRI Technology Improvement

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Heart, Lung, and Blood Institute (NHLBI) on 2026-09-08.