Heart Catheterization Using Magnetic Resonance Imaging (MRI) Fluoroscopy and Passive Guidewires
Background: 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. ...
Conditions:
🦠 Pulmonary Artery Hypertension 🦠 Congenital Heart Disease 🦠 Structural Heart Disease
🗓️ Study Start (Actual) 2 August 2017
🗓️ Primary Completion (Estimated) 30 December 2024
✅ Study Completion (Estimated) 30 December 2025
👥 Enrollment (Estimated) 100
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Bethesda, Maryland, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 12 May 2017
  • First Submitted that Met QC Criteria 12 May 2017
  • First Posted 15 May 2017

Study Record Updates

  • Last Update Submitted that Met QC Criteria 17 July 2024
  • Last Update Posted 18 July 2024
  • Last Verified 13 February 2024