Technical Development for Pediatric Cardiovascular MRI

NCT02892136 | Active Not Recruiting

• 1 other identifier: 2359
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Disease; Cardiovascular Disease

Outcome Measures

Primary Outcomes (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.

  through study completion, an average of 1 year

Secondary Outcomes (1)

• Natural history of congenital heart disease

  through study completion, an average of 1 year

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Clinically indicated exams
• Patients who are undergoing a medically indicated MRI scan or cardiac catheterization procedure
• Patients who are medically judged to have no contraindications to MRI scan
• Written informed consent and assent, when applicable
• Volunteers
• Written informed consent from any normal volunteer 8 years of age or older for a noncontrast, nonsedated cardiac MRI
• Normal adult volunteer to undergo cardiac MRI with contrast agent
• Fetal exams
• Second or third trimester (greater than 13 weeks)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Children's National Research Institute: lead

Study Sites (1)

Children's National Health System

Washington D.C., District of Columbia, 20010, United States

Location

Related Publications (53)

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  PMID: 21509858 RESULT

• Olivieri LJ, Jiang J, Hamann K, Loke YH, Campbell-Washburn A, Xue H, McCarter R, Cross R. Normal right and left ventricular volumes prospectively obtained from cardiovascular magnetic resonance in awake, healthy, 0- 12 year old children. J Cardiovasc Magn Reson. 2020 Feb 3;22(1):11. doi: 10.1186/s12968-020-0602-z.

  PMID: 32013998 DERIVED

MeSH Terms

Conditions

Heart Defects, Congenital; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Russell R Cross, MD

  Children's National Health Systems

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 21, 2016
• First Posted: September 8, 2016
• Study Start: May 1, 2013
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 14, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)