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Radiation-Free Heart Catheterization Using MRI

Primary Purpose

Aortic Coarctation, Cardiomyopathy, Atrial Septal Defect

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MRI guided cardiac catheterization
Magnetic resonance imaging
Sponsored by
Joshua Kanter
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Aortic Coarctation focused on measuring radiation free cardiac catheterization

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's National Health System

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MRI guided cardiac catheterization

Arm Description

Magnetic resonance imaging will be used to guide cardiac catheterization procedures.

Outcomes

Primary Outcome Measures

Test the feasibility of navigating catheters into right heart structures using real-time MRI
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.

Secondary Outcome Measures

Number of participants whose MRI cardiac catheterization procedure was prematurely terminated
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
Measurement of radiation exposure
Comparison of radiation exposure in this cohort of subjects to historical controls undergoing matched invasive cardiology procedure at CNMC.

Full Information

First Posted
February 17, 2016
Last Updated
March 28, 2022
Sponsor
Joshua Kanter
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1. Study Identification

Unique Protocol Identification Number
NCT02739087
Brief Title
Radiation-Free Heart Catheterization Using MRI
Official Title
Radiation-Free Heart Catheterization Using MRI
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 2015 (undefined)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Joshua Kanter

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Coarctation, Cardiomyopathy, Atrial Septal Defect, Aortic Stenosis, Post Heart Transplant Catheter Procedure, Patent Ductus Arteriosus
Keywords
radiation free cardiac catheterization

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MRI guided cardiac catheterization
Arm Type
Experimental
Arm Description
Magnetic resonance imaging will be used to guide cardiac catheterization procedures.
Intervention Type
Procedure
Intervention Name(s)
MRI guided cardiac catheterization
Intervention Description
Magnetic resonance imaging will be used to guide cardiac catheterization procedures whenever possible to avoid or minimize x-ray radiation exposure.
Intervention Type
Device
Intervention Name(s)
Magnetic resonance imaging
Primary Outcome Measure Information:
Title
Test the feasibility of navigating catheters into right heart structures using real-time MRI
Description
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.
Time Frame
At the end of each catheterization procedure through study completion,up to 5 years.
Secondary Outcome Measure Information:
Title
Number of participants whose MRI cardiac catheterization procedure was prematurely terminated
Description
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
Time Frame
At the end of each catheterization procedure through study completion,up to 5 years
Title
Measurement of radiation exposure
Description
Comparison of radiation exposure in this cohort of subjects to historical controls undergoing matched invasive cardiology procedure at CNMC.
Time Frame
End of study, 5 years.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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: Central nervous system aneurysm clips Implanted neural stimulator Implanted cardiac pacemaker or defibrillator which are not MR safe or MR conditional according to the manufacturer Cochlear implant Ocular foreign body (e.g. metal shavings) Implanted Insulin pump 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua Kanter, MD
Organizational Affiliation
Children's National Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's National Health System
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Radiation-Free Heart Catheterization Using MRI

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