MRI and Computational Simulation Cardiology Study

NCT03149341 | Enrolling By Invitation DMC

• 1 other identifier: SQL 80004
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to (1) quantify cardiovascular anatomy and physiology using magnetic resonance imaging under both resting and exercise conditions in patients who have congenital heart disease and in age-matched normal volunteers, (2) use computer models to reproduce and simulate blood flow in these patients, and then (3) to combine the imaging data and computer models to estimate values which cannot be directly measured and to predict physiological changes induced by exercise and medical or surgical therapies.

Conditions

Congenital Heart Disease; Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

• Wall Shear Stress

  Computational parameters derived from clinical diagnostic modalities

  20 years

Study Arms (2)

Study

Congenital heart disease or acquired cardiopulmonary disease who will get (or have gotten) and MRI

Other: Magnetic Resonance Imaging

Normal Volunteers

No congenital heart disease or acquired cardiopulmonary disease who will get (or have gotten) and MRI

Other: Magnetic Resonance Imaging

Interventions

Magnetic Resonance Imaging OTHER

All subjects will undergo or have already undergone Magnetic Resonance Imaging. Normal volunteers will be used for comparison with subjects. To minimize risk, normal volunteers will NOT undergo anesthesia, sedation or receive intravenous contrast during procedure.

Normal Volunteers; Study

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

LPCH and Stanford clinics

You may qualify if:

• patients will have congenital heart disease or acquired cardiopulmonary disease.
• normal volunteers will be willing to undergo MRI

You may not qualify if:

• patients unable to receive intravenous contrast material (this does not apply to normal volunteers)
• subjects with arrhythmias which will prevent MRI cardiac gating
• subjects with illnesses which make participation inappropriate. In addition, patients who would normally be excluded from an MRI study because of pacemaker implant, aneurysm clip, severe claustrophobia, or any other condition which, based on the Investigator's judgment, would preclude proximity to a strong magnetic field will be excluded from this study as well.
• NORMAL VOLUNTEERS may be excluded if they are not able to remain still during the exam or follow the instructions of the investigators.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Lucile Packard Children's Hospital at Stanford

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Heart Defects, Congenital; Hypertension, Pulmonary

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Jeffrey Feinstein, MD, MPH

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MPH. Associate Professor, Pediatrics and, by courtesy, BioEngineering. Director, Pediatric Cardiology Fellowship Program. Director, Vera Moulton Wall Center for Pulmonary Vascular Disease

Study Record Dates

• First Submitted: May 13, 2014
• First Posted: May 11, 2017
• Study Start: February 1, 2008
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): February 1, 2029
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)