Heart Catheterization Using Magnetic Resonance Imaging (MRI) Fluoroscopy and Passive Guidewires
Pulmonary Artery Hypertension, Congenital Heart Disease, Structural Heart Disease
About this trial
This is an interventional diagnostic trial for Pulmonary Artery Hypertension focused on measuring MRI Catheterization, Real-time MRI
Eligibility Criteria
- INCLUSION CRITERIA:
- Age greater than or equal to 18 years old
- Undergoing medically necessary diagnostic or interventional right cardiovascular catheterization, alone or in combination with a left cardiovascular catheterization
EXCLUSION CRITERIA:
- Cardiovascular instability including ongoing acute myocardial infarction, refractory angina or ischemia, and decompensated congestive heart failure.
- Women who are pregnant or nursing
Unable to undergo magnetic resonance imaging
- Cerebral aneurysm clip
- Neural stimulator (e.g. TENS-Unit)
- Any type of ear implant
- 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
EXCLUSION CRITERIA FOR GADOLINIUM-BASED CONTRAST AGENTS:
Renal excretory dysfunction, estimated glomerular filtration rate < 30 mL/min/1.73m2 body surface area according to the Modification of Diet in Renal Disease criteria
Glomerular filtration rate will be estimated using the CKD-EPI equation:
eGFR = 141 x (minimum of (S(Cr)/k, 1)^alpha x (maximum of (S(Cr) /k, 1))^-1.209 x 0.993^Age x 1.018 (if female) x 1.159 (if black)
Where
S(Cr) = serum creatinine
alpha = -0.329 for females and -0.411 for males
k = 0.7 for females and 0.9 for males
Subjects meeting this exclusion criterion may still be included in the study but may not be exposed to gadolinium-based contrast agents.
Exclusion criteria for ferumoxytol:
- Allergy to ferumoxytol or to mannitol excipient
- Does not wish to be exposed to ferumoxytol
Exclusion criteria for MRI left heart catheterization:
-Severe aortic valve stenosis
Sites / Locations
- National Institutes of Health Clinical CenterRecruiting
Arms of the Study
Arm 1
Experimental
1
Open label