Radiation-Free Heart Catheterization Using MRI

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Patent ductus arteriosus
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Brief Title

Radiation-Free Heart Catheterization Using MRI

Official Title

Radiation-Free Heart Catheterization Using MRI

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.

Study Phase

Phase 1

Study Type

Interventional

Primary Outcome

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

Secondary Outcome

 Number of participants whose MRI cardiac catheterization procedure was prematurely terminated

Condition

Aortic Coarctation

Intervention

MRI guided cardiac catheterization

Study Arms / Comparison Groups

 MRI guided cardiac catheterization
Description:  Magnetic resonance imaging will be used to guide cardiac catheterization procedures.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Procedure

Estimated Enrollment

50

Start Date

March 2015

Completion Date

December 2023

Primary Completion Date

August 2023

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:

               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

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Joshua Kanter, MD, 202-476-2020, [email protected]hildrensnational.org

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT02739087

Organization ID

3860

Secondary IDs

Internal Bridge funding

Responsible Party

Sponsor-Investigator

Study Sponsor

Joshua Kanter

Study Sponsor

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

Verification Date

October 2019