MRI and Computational Simulation Cardiology Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Magnetic Resonance Imaging.
- Who it may be relevant to
- Registry conditions: Congenital Heart Disease, Pulmonary Hypertension. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
MR Imaging and Computational Simulation of Cardiovascular Physiology Including Velocity, Pressure, and Wall Shear Stress
Overview
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.
Interventions
- Other Magnetic Resonance Imaging
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.
Primary outcome measures
- Wall Shear Stress [Time frame: 20 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
United States · 1 center
- Lucile Packard Children's Hospital at Stanford — Palo Alto
Identifiers
NCT: NCT03149341 · SQL 80004