MRI and Computational Simulation Cardiology Study

• Conditions: Congenital Heart Disease; Pulmonary Hypertension
• Interventions: Other: Magnetic Resonance Imaging

• Registration Number: NCT03149341
• Lead Sponsor: Stanford University

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.

Detailed Description

Investigators hope to gain a greater understanding of the hemodynamics of congenital heart disease and their associated operations as they pertain to real-life situations (i.e. upright and non-sedentary, rest and exercise). With this knowledge, investigators would look to optimize the geometry and physiology of the patients, potentially reducing several of the long-term complications found in congenital heart disease patients such as cardiomyopathy, pulmonary hypertension, arrhythmias, thrombosis and heart failure.

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2014-05-13
• Study First Submitted QC: 2017-05-09
• Study First Posted: 2017-05-11
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-18
• Primary Completion: 2029-01
• Study Completion: 2029-02

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

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

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study	Magnetic Resonance Imaging	Congenital heart disease or acquired cardiopulmonary disease who will get (or have gotten) and MRI
Normal Volunteers	Magnetic Resonance Imaging	No congenital heart disease or acquired cardiopulmonary disease who will get (or have gotten) and MRI

Primary Outcome Measures

Name	Time	Method
Wall Shear Stress	20 years	Computational parameters derived from clinical diagnostic modalities

Trial Locations

Locations (1)

Lucile Packard Children's Hospital at Stanford; 🇺🇸 Palo Alto, California, United States