Right Heart Catheterization Using Magnetic Resonance Imaging Fluoroscopy and Passive Guidewires

Conditions:High Blood Pressure (Hypertension), Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Age Range:18 - 99
Start Date:August 2, 2017
End Date:December 31, 2022
Contact:Annette Stine, R.N.
Phone:(301) 402-5558

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Right Heart Catheterization Using MRI Fluoroscopy and Passive Guidewires


Right heart catheterization tests heart pressures and flows. Magnetic resonance imaging (MRI)
fluoroscopy shows pictures of the heart that doctors can watch while they work. Researchers
want to test this procedure with a tool called a guidewire. This will help position the heart
catheter into different heart chambers. Guidewires are usually considered unsafe during MRI
because MRI can make them hot inside the body. Researchers have created special MRI settings
that stop one guidewire from getting hot. Using this guidewire during MRI may make improve


To test if certain MRI settings make it safe to use a guidewire during MRI fluoroscopy.


Adults 18 and older whose doctors have recommended right heart catheterization.


Researchers will screen participants by reviewing their lab results and questionnaire

Participants will give 4 blood samples.

Participants will be sedated. They will have a tube (catheter) placed in the groin, arm, or
neck if they don t already have one.

Patches on the skin will monitor heart rhythm. Special antennas, covered in pads, will be
placed against the body.

Participants will lie flat on a table that slides in and out of the MRI scanner as it makes
pictures. Participants will get earplugs for the loud knocking noise. They can talk on an
intercom. They will be inside the scanner for up to 2 hours. They can ask to stop at any

For right heart catheterization, catheters will be inserted through the tubes already in
place. The catheters are guided by MRI fluoroscopy into the chambers of the heart and
vessels. The guidewire will help position the catheter.

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.

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.


- 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


- 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


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)


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
We found this trial at
9000 Rockville Pike
Bethesda, Maryland 20892
Phone: 800-411-1222
National Institutes of Health Clinical Center The National Institutes of Health (NIH) Clinical Center in...
Bethesda, MD
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