Technical Development for Pediatric Cardiovascular MRI

Active, not recruiting

• Conditions: Congenital Heart Disease; Cardiovascular Disease

• Registration Number: NCT02892136
• Lead Sponsor: Children's National 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.

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 Timeline

• Study Start: 2013-05
• Study First Submitted: 2016-07-21
• Study First Submitted QC: 2016-09-01
• Study First Posted: 2016-09-08
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-13
• Last Update Posted: 2022-04-14
• Primary Completion: 2026-05
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 5000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	through study completion, an average of 1 year

Secondary Outcome Measures

Name	Time	Method
Natural history of congenital heart disease	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.

Trial Locations

Locations (1)

Children's National Health System; 🇺🇸 Washington, District of Columbia, United States