Radiation-Free Heart Catheterization Using MRI

Sponsor

Joshua Kanter (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02739087

Collaborator

(none)

Enrollment

Location

Arm

117.1

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

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.

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	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Radiation-Free Heart Catheterization Using MRI

Study Start Date :

Mar 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

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

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

Primary Outcome Measures

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

Number of participants whose MRI cardiac catheterization procedure was prematurely terminated [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
Measurement of radiation exposure [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

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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:

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