Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System
This study is testing a new type of Magnetic Resonance Imaging (MRI) scanner that uses lower energy levels. This new scanner, called a low SAR CMR scanner, might make it safer for people with metal devices in their bodies or during heart procedures that use metal tools. Researchers want to see if this new scanner can create pictures of the heart and other organs that are just as good as, or better than, pictures from standard MRI scanners. They are also optimizing the scanner's settings. This study is looking for both healthy volunteers and people with stable heart disease, or other conditions like neurological or musculoskeletal disease, who are 18 years or older. The goal is to make sure the new low SAR CMR scanner works well and produces clear images.
- Study design
- This is an interventional study that plans to enroll 2950 participants. It involves different groups of participants undergoing MRI scans on the investigational low SAR CMR scanner, and some will also have scans on a conventional MRI scanner for comparison.
- What's involved
- You may have blood tests and undergo one or two MRI scans. If you have two scans, they will be within 60 days of each other. You will also need to follow food restrictions and cooperate with all study procedures.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary goal of the study will be measured at 72 months, which is six years after the start of the study.
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NCT03331380
Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System
Recruiting
NAAges 18+InterventionalDiagnosticNational Heart, Lung, and Blood Institute (NHLBI)Government-funded
~2,950 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:MRI scan - obj 1MRI scans - obj 2MRI scans - obj 3MRI scans - obj 4
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Technical feasibility and Non-inferiority of the above measurements and examinations ob-tained using low SAR CMR versus commercial CMR in healthy volun-teers and in patients with heart disease
Measured over 72 months
Conditions
NCT03331380
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
National Institutes of Health Clinical Center
Bethesda, Marylandstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Marcus Y Chen, M.D. · PRINCIPAL_INVESTIGATOR · National Heart, Lung, and Blood Institute (NHLBI)
Who to contact
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Eligibility criteria
Inclusion
Men and women age greater than or equal to 18 years
Able to provide informed consent in writing
Willingness to cooperate with all study procedures (including food restriction) and available for scheduled study events
Currently healthy, self-reported
Subjects having known heart disease including but not limited to
Stable angina pectoris due to epicardial coronary artery obstruction
Past myocardial infarction
Heart failure with reduced ejection fraction
Valvular heart disease
Pulmonary artery hypertension
Congenital heart disease with or without prior repair
Myocarditis
Infiltrative cardiomyopathy
Hypertrophic cardiomyopathy
Having known brain disease including but not limited to:
Transient ischemic attack or stroke after 24 hours of onset
Infection, inflammation meningitis
Cognitive decline, neurodegenerative disorders
Demyelinating disease, multiple sclerosis
Loss of consciousness, seizures, epilepsy
Brain tumor, metastases, abscess, lesion
Vascular pathology
Headache
Hemorrhage
Trauma
Have known musculoskeletal disease including but not limited to:
Persistent neck pain or radiculopathy
Cancer or tumors of the spine
Congenital abnormalities of the spinal cord or knee
Multiple sclerosis
Injury or trauma
Fracture evaluation
Infectious or inflammatory processes
Soft tissue damage
Muscle or tendon disorders
Knee meniscal disorders
Marrow abnormalities
Mechanical knee symptoms
Vascular conditions
Have known abdominal diseases including but not limited to:
Bowel obstruction
Masses and tumors
Crohns disease
Diffuse liver disease such as hemochromatosis, hemosiderosis, fatty infiltration
Focal hepatic lesions
Cirrhotic liver
Iron content determination
Cystic kidney disease
Vascular abnormalities
Have known lung disease including but not limited to:
Cancer, tumors and masses
Vascular and lymphatic abnormalities
Pulmonary thromboembolic disease
Trauma
Suspected bronchiolitis
Bronchiectasis or pneumonitis
Asthma and other obstructive lung diseases
Pulmonary lymphangioleiomyomatosis
Cystic and interstitial lung diseases such as pulmonary lymphangioleiomyomatosis and cystic fibrosis
Have other known non-cardiovascular disease
Exclusion
Conditions that are thought to make MRI unsafe (that will be determined by filling out a separate form) including:
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 implant unless it is labeled safe for MRI
Ocular foreign body (e.g. metal shavings)
Metal shrapnel or bullet
Any implanted device (e.g. insulin pump, drug infusion device), unless it is labeled safe for MRI
Pregnancy. When uncertain, subjects will undergo either urine or serum pregnancy testing. Results from up to 3 days prior to the examination will be used. Post-menopausal and surgically sterilized subjects are exempt from this testing.
If a urine or serum pregnancy test was administered as part of a referral protocol, and the test was administered up to 3 days prior to MRI examination for this protocol, a new pregnancy test will not be required for this protocol.
If a pregnancy test has not been administered within 3 days of MRI examination for this protocol, a serum or urine pregnancy test will be administered. Medical personnel will determine which pregnancy test is appropriate based on subject s medical history, screening, and individual scenario. 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.
When gadolinium based contrast agent (GBCA) exposure is planned
Objective 1 and 2, Healthy Volunteers: No gadolinium based contrast agent exposure is permitted if eGFR \< 60 mL/min/1.73m\^(2) using the CKD-EPI equation or equivalent and a serum creatinine measured within 2 weeks without intercurrent change in medical condition or medications.
Objective 3 and 4, Volunteers with Cardiac and Non-Cardiac Disease: No gadolinium based contrast agent exposure is permitted if eGFR \< 30 mL/min/1.73m\^(2) using the CKDEPI equation \[25\] or equivalent and a serum creatinine measured within 2 weeks without
For all objectives not more than two research MRI exams with GBCA exposure in a 12 month period. Research MRI exams performed outside of this protocol will be included in the 12 month period.
Subjects meeting this exclusion criterion, or without eGFR determination, may still be included in the study but may not be exposed to gadolinium-based contrast agents
Breast feeding (unless subject is willing to discard breast milk for 24 hours)
Does not wish to be exposed to gadolinium.
Severe chronic obstructive pulmonary disease defined as requiring more than one bronchodilator medication every day or continuous oxygen requiring
Prior treatment with bleomycin
A history of allergic reaction to any intravenous iron product
Allergy to ferumoxytol or to mannitol excipient
Breast feeding
Does not wish to be exposed to ferumoxytol
Iron overload
A history of reaction to oral contrast (if using barium sulfate)
Breast feeding unless subject is willing to discard breast milk for 24 hours (if using barium sulfate)
Allergy to pineapple (if using pineapple juice)
Does not wish to be exposed to oral contrast
Important past medical illness
Unstable angina, acute coronary syndrome, or myocardial infarction not attributable to PCI, within 2 weeks unless after coronary revascularization of the culprit lesion.
Any hemodynamic instability or decompensated heart failure as determined by the enrolling physician.
Adenosine: Patients with asthma or chronic obstructive pulmonary disease of any severity are ineligible for vasodilator stress CMR with adenosine.
Regadenoson: Only patients with severe or uncontrolled asthma or severe or uncontrolled chronic obstructive pulmonary disease are ineligible for vasodilator stress CMR with regadenoson. This will be determined at the discretion of the supervising provider based on medical records and physical exam.
Patients with advanced heart block on baseline ECG are ineligible for vasodilator stress CMR
Acute illness for which investigational imaging might delay care (such as acute stroke before treatment), as determined by the enrolling physician
Any hemodynamic instability as determined by the enrolling physician.
Subjects with MRI-conditional and legacy CIEDs are not excluded, based on the intrinsic safety of low-SAR MRI.
Subjects with CIEDs are excluded if they have pacemakers implanted before 1998; ICDs implanted before 2000; temporary, epicardial or abandoned leads; and CIEDs implanted \<4 weeks prior to MRI exam.
Subjects with CIED are excluded from conventional MRI unless they have CIEDs that are labeled as MRI conditional or MRI safe, and that are implanted greater than or equal to 4 weeks prior to MRI.
What this trial measures
- Technical feasibility and Non-inferiority of the above measurements and examinations ob-tained using low SAR CMR versus commercial CMR in healthy volun-teers and in patients with heart disease72 months
To determine whether the the low SAR CMR is a feasible alternative to standard CMR