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Clinical Trials/NCT03149341
NCT03149341
Enrolling By Invitation
Not Applicable

MR Imaging and Computational Simulation of Cardiovascular Physiology Including Velocity, Pressure, and Wall Shear Stress

Stanford University1 site in 1 country75 target enrollmentFebruary 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Congenital Heart Disease
Sponsor
Stanford University
Enrollment
75
Locations
1
Primary Endpoint
Wall Shear Stress
Status
Enrolling By Invitation
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2008
End Date
February 2029
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jeffrey A. Feinstein

MD, MPH. Associate Professor, Pediatrics and, by courtesy, BioEngineering. Director, Pediatric Cardiology Fellowship Program. Director, Vera Moulton Wall Center for Pulmonary Vascular Disease

Stanford University

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.

Outcomes

Primary Outcomes

Wall Shear Stress

Time Frame: 20 years

Computational parameters derived from clinical diagnostic modalities

Study Sites (1)

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