Clinical Trial Finder

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  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

Heart catheterization is a minimally invasive procedure to measure pressure into specific heart cavities. Heart catheterization usually uses X-ray guidance, which involves radiation exposure, and which fails to visualize soft tissue. For several years, real-time magnetic resonance imaging (MRI) fluoroscopy has been the standard technique to guide right heart catheterization at the NIH clinical center. Guidewires are standard tools used to steer catheters through the body and heart. Guidewires have not been used during MRI fluoroscopy catheterization because of the risk of heating. We have developed MRI techniques that do not risk heating using specific commercial guidewires. In this protocol we will use this new low-energy real-time MRI fluoroscopy technique to enable use of guidewires during otherwise standard MRI catheterization of the right side of the heart through veins, and of the left side of the heart through the aorta. In the second phase of the protocol, we will begin performing systematic MRI guidewire heart catheterization without X-ray whenever possible. We will assess the heart s response to hemodynamic provocation during MRI catheterization tailored to the patient s problem. We will use this protocol to further refine the technique. This will enable future testing of devices for adult and pediatric MRI-fluoroscopy catheterization, which may lead to new non-surgical treatments of cardiovascular disease.

Arms

Experimental: 1

Open label

Interventions

Procedure: - MRI Heart guidewire catheterization

to conduct left and right heart guidewire catheterization using real-time MRI fluoroscopy in human research subjects already undergoing medically necessary left and right heart catheterization. We will use only passive MRI-compatible catheters and a specific guidewire shown to be safe under specific conditions. Under the conditions of use, the guidewire is not susceptible to heating.