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Heart Catheterization Using Magnetic Resonance Imaging (MRI) Fluoroscopy and Passive Guidewires

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03152773
Recruitment Status : Recruiting
First Posted : May 15, 2017
Last Update Posted : July 8, 2020
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

Tracking Information
First Submitted Date  ICMJE May 12, 2017
First Posted Date  ICMJE May 15, 2017
Last Update Posted Date July 8, 2020
Actual Study Start Date  ICMJE August 2, 2017
Estimated Primary Completion Date December 30, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2020)
The principal objective of this protocol is to test the safety and feasibility of MRI fluoroscopy catheter navigation using 0.035" guidewires during right and left heart catheterization guided by low-SAR MRI pulse sequences [ Time Frame: 2 hours ]
Acquisition of hemodynamic and saturation data from targeted chambers and vessels.
Original Primary Outcome Measures  ICMJE
 (submitted: May 12, 2017)
To test the safety of performing right heart catheterization with a Terumo Glidewire guided by low-SAR MRI fluoroscopy [ Time Frame: 2 hours ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 1, 2018)
Additional objectives are to test and enhanced MRI as an adjunct to routine hemodynamic cardiac catheterization [ Time Frame: 2 hours ]
Conspicuity of Glidewires during MRI fluoroscopy catheterization
Original Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2017)
To test in vivo human conspicuity of the glidewire using off-resonance MR image reconstruction. [ Time Frame: 2 hours ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Heart Catheterization Using Magnetic Resonance Imaging (MRI) Fluoroscopy and Passive Guidewires
Official Title  ICMJE Heart Catheterization Using MRI Fluoroscopy and Passive Guidewires
Brief Summary


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.


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 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

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Pulmonary Artery Hypertension
  • Congenital Heart Disease
  • Structural Heart Disease
Intervention  ICMJE Procedure: MRI Right and Left Heart guidewire catheterization
To conduct right and left heart guidewire catheterization using real-time MRI fluoroscopy in human research subjects already undergoing medically necessary right and left heart catheterization. We will use only passive MRI-compatible catheters and specific guidewires shown to be safe under low energy MRI specific conditions. Under the conditions of use, the guidewire is not susceptible to heating.
Study Arms  ICMJE Experimental: 1
Open label
Intervention: Procedure: MRI Right and Left Heart guidewire catheterization
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 24, 2018)
Original Estimated Enrollment  ICMJE
 (submitted: May 12, 2017)
Estimated Study Completion Date  ICMJE December 30, 2025
Estimated Primary Completion Date December 30, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • 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

Exclusion criteria for MRI left heart catheterization:

-Severe aortic valve stenosis

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Annette Stine, R.N. (301) 402-5558
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT03152773
Other Study ID Numbers  ICMJE 170095
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
Study Sponsor  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Robert J Lederman, M.D. National Heart, Lung, and Blood Institute (NHLBI)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date June 24, 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP