Technical Development for Pediatric Cardiovascular MRI

Cardiovascular Disease Clinical Trial

Official title:

Technical Development for Pediatric Cardiovascular MRI

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02892136
• Other study ID #: 2359
• Status: Active, not recruiting
• Start date: May 2013
• Est. completion date: December 2026

Study information

• Verified date: April 2022
• Source: Children's National Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5000
• Est. completion date: December 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Locations

Country	Name	City	State
United States	Children's National Health System	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Children's National Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (52)

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* Note: There are 52 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Natural history of congenital heart disease	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