Testing a new low energy MRI scanner for heart imaging

Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System

This study is testing a new low-energy MRI scanner to see if it can create better heart images safely for both healthy people and those with heart disease, including those with metal implants.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 2950 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
• Drugs / interventions: radiation
• Locations: 1 site (Bethesda, Maryland)
• Trial ID: NCT03331380 on ClinicalTrials.gov

What this trial studies

This study evaluates a novel magnetic resonance imaging (MRI) scanner that operates at a lower specific absorption rate (SAR) to create high-quality images of the heart. The research aims to optimize scanner protocols and compare the accuracy of this low SAR CMR against conventional CMR in both healthy volunteers and patients with known heart disease. Participants will undergo MRI scans while their heart activity is monitored, and the study will assess the feasibility of using this technology for patients with metallic implants. The goal is to enhance cardiac imaging safety and effectiveness.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with known heart disease or healthy volunteers.

Not a fit: Patients with severe acute heart conditions or those unable to undergo MRI due to contraindications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enable safer cardiac imaging for patients with metal implants and improve diagnostic accuracy.

How similar studies have performed: While the approach of using low SAR CMR is innovative, similar studies have shown promise in enhancing MRI safety and image quality.

Eligibility criteria

* INCLUSION CRITERIA:

Inclusion Criteria for All Participants (Objectives 1, 2, 3, and 4)

* 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

Inclusion Criteria for Healthy Volunteers (Objectives 1 and 2)

-Currently healthy, self-reported

Inclusion Criteria for Subjects with Heart Disease (Objective 3)

* 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

Inclusion Criteria for Subjects with Non-Cardiac Disease (Objective 4)

* 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

Inclusion criteria for bronchodilators:

\- Only subjects who use bronchodilators routinely or those have undergone previous pulmonary function testing with bronchodilators will be invited to undergo bronchodilator testing during MRI.

EXCLUSION CRITERIA:

Exclusion Criteria for All Participants:

* 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.

Exclusion Criteria for Gadolinium:

-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

intercurrent change in medical condition or medications.

--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.

Exclusion Criteria for Oxygen Inhalation:

* Severe chronic obstructive pulmonary disease defined as requiring more than one bronchodilator medication every day or continuous oxygen requiring
* Prior treatment with bleomycin

Exclusion Criteria for Ferumoxytol Contrast

* 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

Exclusion Criteria for oral contrast agent:

* 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

Exclusion Criteria for Healthy Volunteers (Objectives 1 and 2)

-Important past medical illness

Exclusion Criteria for Adults with heart Disease (Objective 3)

* 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

Exclusion Criteria for Adults with Non-Cardiac Disease (Objective 4)

* 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.

Exclusion criteria for bronchodilators:

\- Patient refuses bronchodilator administration.

Exclusion criteria for adults with cardiac implanted electronic devices (CIED, pacemakers or defibrillators:

Low-SAR MRI:

* 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.

Conventional MRI:

-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.

Where this trial is running

Bethesda, Maryland

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)

Study contacts

• Principal investigator: Adrienne E Campbell, Ph.D. — National Heart, Lung, and Blood Institute (NHLBI)
• Study coordinator: Anastasia Tsakirellis, C.R.N.P.

Conditions CAD; 1.5 T CMR; Low SAR CMR; Gadolinium; Regadenoson; Adenosine