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

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

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.

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.

\- Patient refuses bronchodilator administration.

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.

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

What this study is about

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

What this study is about