Radiation-Free Heart Catheterization Using MRI

NCT02739087 | Active Not Recruiting

• 2 other identifiers: 3860Internal Bridge funding
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Coarctation; Cardiomyopathy; Atrial Septal Defect; Aortic Stenosis; Post Heart Transplant Catheter Procedure; Patent Ductus Arteriosus

Keywords

radiation free cardiac catheterization

Outcome Measures

Primary Outcomes (1)

• 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.

  At the end of each catheterization procedure through study completion,up to 5 years.

Secondary Outcomes (2)

• 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

• Measurement of radiation exposure

  End of study, 5 years.

Study Arms (1)

MRI guided cardiac catheterization

EXPERIMENTAL

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

Procedure: MRI guided cardiac catheterization; Device: Magnetic resonance imaging

Interventions

MRI guided cardiac catheterization PROCEDURE

Magnetic resonance imaging will be used to guide cardiac catheterization procedures whenever possible to avoid or minimize x-ray radiation exposure.

MRI guided cardiac catheterization

Magnetic resonance imaging DEVICE

MRI guided cardiac catheterization

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing a medically necessary cardiovascular catheterization

You may not qualify if:

• 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
• \. Renal disease with estimated glomerular filtration rate \< 30 ml/min/1.73 m2 body surface area

Sponsors & Collaborators

• Joshua Kanter: lead

Study Sites (1)

Children's National Health System

Washington D.C., District of Columbia, 20010, United States

Location

Related Publications (64)

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  PMID: 28874164 DERIVED

MeSH Terms

Conditions

Aortic Coarctation; Cardiomyopathies; Heart Septal Defects, Atrial; Aortic Valve Stenosis; Ductus Arteriosus, Patent

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Septal Defects; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Joshua Kanter, MD

  Children's National Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 17, 2016
• First Posted: April 14, 2016
• Study Start: March 1, 2015
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)