Right Heart Catheterization Using Magnetic Resonance Imaging Fluoroscopy and Passive Guidewires
| Status: | Recruiting |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 4/6/2019 |
| Start Date: | August 2, 2017 |
| End Date: | December 31, 2022 |
| Contact: | Annette Stine, R.N. |
| Email: | stinea@nhlbi.nih.gov |
| Phone: | (301) 402-5558 |
Right Heart Catheterization Using MRI Fluoroscopy and Passive Guidewires
Background:
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
catheterization.
Objectives:
To test if certain MRI settings make it safe to use a guidewire during MRI fluoroscopy.
Eligibility:
Adults 18 and older whose doctors have recommended right heart catheterization.
Design:
Researchers will screen participants by reviewing their lab results and questionnaire
answers.
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
time.
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.
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
catheterization.
Objectives:
To test if certain MRI settings make it safe to use a guidewire during MRI fluoroscopy.
Eligibility:
Adults 18 and older whose doctors have recommended right heart catheterization.
Design:
Researchers will screen participants by reviewing their lab results and questionnaire
answers.
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
time.
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.
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.
- 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
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
301-496-2563
Phone: 800-411-1222
National Institutes of Health Clinical Center The National Institutes of Health (NIH) Clinical Center in...
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