Normal and Abnormal Cardiovascular PhysiologyNCT03581318
Technical and Translational Development of Cardiovascular Magnetic Resonance (CMR) Imaging
An observational study of Normal and Abnormal Cardiovascular Physiology, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal and Abnormal Cardiovascular Physiology
- How many people
- 5,000 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2018to 1 Apr 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY8664111010, prpl@cc.nih.gov
About this study
Official title: Technical and Translational Development of Cardiovascular MRI (CMR)
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.
Read more
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.
Read the detailed description
The purpose of this protocol is to develop and test new MRI techniques applicable to patients undergoing cardiovascular evaluation with the ultimate goal of translating the technical advances into improving clinical diagnosis and management of patients undergoing cardiovascular evaluation. Patients undergoing cardiovascular evaluation and healthy volunteers will be scanned under the protocol. We will evaluate new developments in non-contrast and contrast MRI of the heart and blood vessels and novel postprocessing methods.
The use of the newer sequences will be used to improve clinical imaging workflow and disease diagnosis. We hope to use this protocol to clearly describe cardiovascular disease and associated problems using novel MRI methods and follow certain subsets of patients with disease as part of a natural history process. Inter-related physiologic systems may be phenotyped by MRI with characterization of disease associations between different organ systems.
Additionally, information regarding gadolinium deposition of the brain will be gathered. The literature regarding deposition of gadolinium in the brain has a large void regarding information of prevalence of the phenomenon in healthy subjects. The National Institutes of Health has a large healthy subject pool who have participated in gadolinium contrast MRI studies. This pool of healthy subjects is not easily available at most clinical MRI centers, and thus, we are uniquely well-situated to be able to answer this outstanding question.
For all objectives, MRI studies will be conducted in the NIH MRI systems located at the NIH Clinical Center in Bethesda, Maryland. These procedures may involve the intravenous administration of commercially available MR contrast media and exercise or pharmacologic stress testing. Results will be used to evaluate the performance of various research pulse sequences, gradient coils, and radiofrequency receiver coils on human subjects and will provide essential ground work for specific patient protocols, both diagnostic and therapeutic.
- Keywords
- Congenital Heart Defects, Heart Valve Diseases, Chest pain (angina), Heart Failure, Coronary Heart Disease, CABG, CARDIOMYOPATHY, Atherosclerosis, MRI Technology Improvement
- Medical subject headings
- Heart Defects, Congenital, Heart Valve Diseases, Chest Pain, Angina Pectoris, Heart Failure, Coronary Disease, Cardiomyopathies, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: on going
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.
Measured: on going
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.
Measured: on going
Assesment of Gad deposition in the brain
Assessment of non-contrast MRI findings that are consistent with gadolinium deposition.
Measured: on going
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2018
- Study start12 Jul 2018
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Normal and Abnormal Cardiovascular PhysiologyStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- W. Patricia Bandettini, M.D., Principal investigator, National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03581318
- Sponsor's protocol ID
- 180118
- Other IDs
- 18-H-0118
- Status last verified
- 29 Sep 2026
- First submitted
- 3 Jul 2018
- Last updated
- 5 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The study team will make a decision on this matter.
Publications
Bandettini WP, Shanbhag SM, Mancini C, Henry JL, Lowery M, Chen MY, Xue H, Kellman P, Campbell-Washburn AE. Evaluation of Myocardial Infarction by Cardiovascular Magnetic Resonance at 0.55-T Compared to 1.5-T. JACC Cardiovasc Imaging. 2021 Sep;14(9):1866-1868. doi: 10.1016/j.jcmg.2021.02.024. Epub 2021 May 19. No abstract available.
PubMed 34023254Bandettini WP, Shanbhag SM, Mancini C, McGuirt DR, Kellman P, Xue H, Henry JL, Lowery M, Thein SL, Chen MY, Campbell-Washburn AE. A comparison of cine CMR imaging at 0.55 T and 1.5 T. J Cardiovasc Magn Reson. 2020 May 18;22(1):37. doi: 10.1186/s12968-020-00618-y.
PubMed 32423456