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 2024
Primary Completion Date
December 2024
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]
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
February 2021