Technical Development for Pediatric Cardiovascular MRI

April 13, 2022 updated by: Russell Cross, Children's National Research Institute
This study will explore new ways of using magnetic resonance imaging (MRI) to evaluate pediatric patients with cardiovascular disease,congenital heart disease in patients of all ages, fetuses undergoing clinically indicated MR imaging.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

The purpose of this protocol is to allow development and testing of new MRI techniques suitable for evaluating patients with cardiovascular disease, congenital heart disease, fetal cardiac structure, function, and physiology, and other fetal organ analysis. Individuals referred to Children's National Medical Center for a clinically indicated cardiac MRI or cardiac catheterization by their primary referring cardiologist or obstetrician, and who are enrolled in this study may also undergo additional research imaging.

Since such technical development work often depends on preliminary studies in healthy volunteers, the protocol also recruits healthy subjects.

Study Type

Observational

Enrollment (Anticipated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Children's National Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Individuals referred to Children's National Medical Center for a clinically indicated cardiac MRI or cardiac catheterization by their primary referring cardiologist will be considered potential candidates for inclusion in technical development research.

Technical development work often depends on preliminary studies in healthy volunteers. This protocol also enrolls healthy subjects.

Description

Inclusion Criteria:

Clinically indicated exams

  1. Patients who are undergoing a medically indicated MRI scan or cardiac catheterization procedure
  2. Patients who are medically judged to have no contraindications to MRI scan
  3. Age inclusion: infant to adult
  4. Written informed consent and assent, when applicable

Volunteers

  1. Written informed consent from any normal volunteer 8 years of age or older for a noncontrast, nonsedated cardiac MRI
  2. Normal adult volunteer to undergo cardiac MRI with contrast agent

Fetal exams

  1. Age inclusion:18 years and older
  2. Second or third trimester (greater than 13 weeks)

Exclusion Criteria:

  1. All patients who are medically judged to have contraindication(s) to MRI scanning will be excluded. Contraindications include implanted metal devices which are contraindicated for MRI scanning:

    • Central nervous system aneurysm clips;
    • Implanted neural stimulator;
    • Implanted cardiac pacemaker or defibrillator;
    • Cochlear implant;
    • Ocular foreign body (e.g. metal shavings);
    • Implanted Insulin pump;
    • Metal shrapnel or bullet.

  2. Exclusion criteria for Bicycle Stress MRI

    • Myocardial infarction within 24 hours
    • Active myocarditis
    • Uncontrolled heart failure
    • Severe left ventricular outflow tract obstruction

  3. Exclusion Criteria for adult volunteers undergoing MRI with administration of contrast agent:

    • 60 years of age or older
    • Renal Disease; Glomerular Filtration rate (eGFR < 30 ml/min/1.73 m2) will be determined by a simple blood test done at the bedside
    • Use of diuretics
    • Diagnosis of hypertension and diabetes

  4. Exclusion criteria for volunteers undergoing both contrast and non-contrast

    MRI scans:

    • Pregnant women:

      1. Women of childbearing potential will be required to have a screening urine pregnancy test

  5. Exclusion criteria for

    • Pregnant woman for whom 15 additional minutes lying flat in the MR scanner would represent a risk (i.e. severe claustrophobia, congestive heart failure)
    • Pregnant minor under the age of 18
    • Less than 13 weeks gestation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate innovative noninvasive MRI techniques suitable for evaluating pediatric patients with cardiovascular disease, congenital cardiac disease, and fetal organ analysis including cardiac structure, function, and physiology.
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Natural history of congenital heart disease
Time Frame: through study completion, an average of 1 year
A secondary objective of this protocol is to catalog results from MR imaging studies that can be used to describe the natural history of congenital heart disease and other cardiovascular diseases acquired in the young.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's National Research Institute

Investigators

  • Principal Investigator: Russell R Cross, MD, Children's National Health Systems

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Anticipated)

May 1, 2026

Study Completion (Anticipated)

December 1, 2026

Study Registration Dates

First Submitted

July 21, 2016

First Submitted That Met QC Criteria

September 1, 2016

First Posted (Estimate)

September 8, 2016

Study Record Updates

Last Update Posted (Actual)

April 14, 2022

Last Update Submitted That Met QC Criteria

April 13, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2359

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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