Radiation-Free Heart Catheterization Using MRI

February 5, 2024 updated by: Joshua Kanter
Currently catheters used in heart catheterization procedures are guided throughout the heart chambers and blood vessels by pictures taken by x-rays. This technology exposes patients to radiation. With this study protocol the investigators will use MRI technology to take real-time pictures to navigate catheters throughout heart chambers. MRI uses electromagnetic energy; therefore, it does not expose participants to radiation energy.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Participants undergo general anesthesia, and vascular access is obtained in the x-ray catheterization lab. Next the participant is transferred into the MRI scanner where a focused MRI examination is performed. Catheters are then guided into the heart chambers using real-time MRI guidance to perform conventional cardiac catheterization steps. If time allows, additional research MRI is performed before the participant is returned to the x-ray catheterization lab. If any MRI guided catheterization steps are unsuccessful, the clinically indicated step is performed after the participant returns to the x-ray catheterization lab using conventional x-ray guided pictures.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Children's National Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Undergoing a medically necessary cardiovascular catheterization

Exclusion Criteria:

  • Cardiovascular instability including hemodynamic instability (such as requiring significant vasoactive infusion support) or mechanical hemodynamic support.
  • Women who are pregnant
  • Women who are nursing and who do not plan to discard breast milk for 24 hours

  • Patients with a contraindication to MRI scanning will be excluded. These contraindications include patients with the following devices:

    1. Central nervous system aneurysm clips
    2. Implanted neural stimulator
    3. Implanted cardiac pacemaker or defibrillator which are not MR safe or MR conditional according to the manufacturer
    4. Cochlear implant
    5. Ocular foreign body (e.g. metal shavings)
    6. Implanted Insulin pump
    7. Metal shrapnel or bullet

Exclusion criteria for Gadolinium (contrast agent)

1. Renal disease with estimated glomerular filtration rate < 30 ml/min/1.73 m2 body surface area

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MRI guided cardiac catheterization
Magnetic resonance imaging will be used to guide cardiac catheterization procedures.
Device: Magnetic resonance imaging
Procedure: MRI guided cardiac catheterization
Magnetic resonance imaging will be used to guide cardiac catheterization procedures whenever possible to avoid or minimize x-ray radiation exposure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Test the feasibility of navigating catheters into right heart structures using real-time MRI
Time Frame: At the end of each catheterization procedure through study completion,up to 5 years.
Heart catheterization usually uses X-ray guidance. Using commercially available MRI-compatible catheters, the right heart catheterization procedure will be done using real-time magnetic resonance imaging (MRI). MRI guidance does not use X-ray radiation.
At the end of each catheterization procedure through study completion,up to 5 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants whose MRI cardiac catheterization procedure was prematurely terminated
Time Frame: At the end of each catheterization procedure through study completion,up to 5 years

Premature termination will occur under the following circumstances:

  • Hemodynamic or other clinical instability
  • Technical failure of catheter procedure such as being unable to navigate the catheters to the heart chamber
  • Equipment malfunction
  • Any other circumstance that in the opinion of the Principal Investigator poses hazard to the research subject
At the end of each catheterization procedure through study completion,up to 5 years
Measurement of radiation exposure
Time Frame: End of study, 5 years.
Comparison of radiation exposure in this cohort of subjects to historical controls undergoing matched invasive cardiology procedure at CNMC.
End of study, 5 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Joshua Kanter

Investigators

  • Principal Investigator: Joshua Kanter, MD, Children's National Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start

March 1, 2015

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

February 17, 2016

First Submitted That Met QC Criteria

April 13, 2016

First Posted (Estimated)

April 14, 2016

Study Record Updates

Last Update Posted (Actual)

February 6, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3860
  • Internal Bridge funding (Other Identifier: Children's Research Institute, Children's National)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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