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Technical Development for Pediatric Cardiovascular MRI

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ClinicalTrials.gov Identifier: NCT02892136
Recruitment Status : Recruiting
First Posted : September 8, 2016
Last Update Posted : July 24, 2018
Sponsor:
Information provided by (Responsible Party):
Russell Cross, Children's Research Institute

Brief Summary:
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.

Condition or disease
Congenital Heart Disease Cardiovascular Disease

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.


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Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Technical Development for Pediatric Cardiovascular MRI
Study Start Date : May 2013
Estimated Primary Completion Date : May 2026
Estimated Study Completion Date : December 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02892136


Contacts
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Contact: Russell R Cross, M.D. 202-476-2020 rcross@childrensnational.org
Contact: Laura Olivieri, M.D. 202-476-2020 lolivieri@childrensnational.org

Locations
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United States, District of Columbia
Children's National Health System Recruiting
Washington, District of Columbia, United States, 20010
Contact: Russell R Cross, MD    202-476-2020    rcross@childsrensnational.org   
Contact: Laura Olivieri, MD    202-476-2020    lolivieri@childsrensnational.org   
Sponsors and Collaborators
Children's Research Institute
Investigators
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Principal Investigator: Russell R Cross, MD Children's National Health Systems

Publications of Results:
Other Publications:

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Responsible Party: Russell Cross, MD, Children's Research Institute
ClinicalTrials.gov Identifier: NCT02892136     History of Changes
Other Study ID Numbers: 2359
First Posted: September 8, 2016    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Cardiovascular Diseases
Heart Diseases