Technical Development for Pediatric Cardiovascular MRI

NCT ID: NCT02892136

Last Updated: 2022-04-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 5000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2026-12-31

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.

Conditions

Congenital Heart Disease; Cardiovascular Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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.

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

• 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

MRI scans:

• Pregnant women:

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

• 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Children's National Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Russell Cross

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Russell R Cross, MD

Role: PRINCIPAL_INVESTIGATOR

Children's National Health Systems

Locations

Children's National Health System

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

Countries

United States

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Other Identifiers

2359

Identifier Type: -

Identifier Source: org_study_id