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Radiation-Free Heart Catheterization Using MRI

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ClinicalTrials.gov Identifier: NCT02739087
Recruitment Status : Recruiting
First Posted : April 14, 2016
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
Joshua Kanter, Children's Research Institute

Study Description
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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.

Condition or disease Intervention/treatment Phase
Aortic Coarctation Cardiomyopathy Atrial Septal Defect Aortic Stenosis Post Heart Transplant Catheter Procedure Patent Ductus Arteriosus Procedure: MRI guided cardiac catheterization Device: Magnetic resonance imaging Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Radiation-Free Heart Catheterization Using MRI
Study Start Date : March 2015
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans

Arms and Interventions
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Arm Intervention/treatment
Experimental: MRI guided cardiac catheterization
Magnetic resonance imaging will be used to guide cardiac catheterization procedures.
 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.

Device: Magnetic resonance imaging


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

    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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02739087


Contacts
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Contact: Joshua Kanter, MD 202-476-2020 jkanter@childrensnational.org
Contact: Laura Olivieri, MD 202-476-2020 lolivieri@childrensnational.org

Locations
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United States, District of Columbia
Children's National Health System Recruiting
Washington, District of Columbia, United States, 20010
Contact: Joshua Kanter, MD    202-476-2020    jkanter@childrensnational.org   
Contact: Laura Olivieri, MD    202-476-2020    lolivieri@childrensnational.org   
Principal Investigator: Joshua Kanter, MD         
Sub-Investigator: Russell Cross, MD         
Sub-Investigator: Laura Olivieri, MD         
Sponsors and Collaborators
Joshua Kanter
Investigators
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Principal Investigator: Joshua Kanter, MD Children's Research Institute
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Joshua Kanter, MD, Children's Research Institute
ClinicalTrials.gov Identifier: NCT02739087     History of Changes
Other Study ID Numbers: 3860
Internal Bridge funding ( Other Identifier: Children's Research Institute, Children's National )
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Joshua Kanter, Children's Research Institute:
radiation free cardiac catheterization
Additional relevant MeSH terms:
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Cardiomyopathies
Aortic Valve Stenosis
Ductus Arteriosus, Patent
Aortic Coarctation
Heart Septal Defects, Atrial
Heart Diseases
Cardiovascular Diseases
 Heart Valve Diseases
Ventricular Outflow Obstruction
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities
Heart Septal Defects