Heart Catheterization Using Magnetic Resonance Imaging (MRI) Fluoroscopy and Passive Guidewires
NCT ID: NCT03152773
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
SUSPENDED
NA
22 participants
INTERVENTIONAL
2017-08-02
2027-12-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
A heart catheterization is a diagnostic heart procedure used to measure pressures and take pictures of the blood flow through the heart chambers. Magnetic resonance imaging (MRI) fluoroscopy shows continuous pictures of the heart chambers that doctors can watch while they work. Researchers want to test this procedure with catheterization tools routinely used in x-ray catheterization called guidewires. Guidewires will help move the heart catheter through the different heart chambers. Guidewires are usually considered unsafe during MRI because MRI can cause a guidewire to heat while inside the blood vessels and heart. Researchers are testing special low energy MRI settings that allow certain guidewires to be used during MRI catheterization without heating. Using these guidewires during MRI may help to decrease the amount of time you are in the MRI scanner, and the overall time the MRI catheterization procedure takes.
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 may 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.
During a 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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Open label
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Undergoing medically necessary diagnostic or interventional right cardiovascular catheterization, alone or in combination with a left cardiovascular catheterization
Exclusion Criteria
* 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)
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.
* Allergy to ferumoxytol or to mannitol excipient
* Does not wish to be exposed to ferumoxytol
-Severe aortic valve stenosis
18 Years
100 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Robert J Lederman, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Heart, Lung, and Blood Institute (NHLBI)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
National Institutes of Health Clinical Center
Bethesda, Maryland, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Campbell-Washburn AE, Rogers T, Stine AM, Khan JM, Ramasawmy R, Schenke WH, McGuirt DR, Mazal JR, Grant LP, Grant EK, Herzka DA, Lederman RJ. Right heart catheterization using metallic guidewires and low SAR cardiovascular magnetic resonance fluoroscopy at 1.5 Tesla: first in human experience. J Cardiovasc Magn Reson. 2018 Jun 21;20(1):41. doi: 10.1186/s12968-018-0458-7.
Related Links
Access external resources that provide additional context or updates about the study.
NIH Clinical Center Detailed Web Page
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
170095
Identifier Type: -
Identifier Source: org_study_id
17-H-0095
Identifier Type: -
Identifier Source: secondary_id