MRI and Computational Simulation Cardiology Study

Sponsor
Stanford University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT03149341
Collaborator
(none)
75
1
204
0.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Magnetic Resonance Imaging

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 Design

Study Type:
Observational
Anticipated Enrollment :
75 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
MR Imaging and Computational Simulation of Cardiovascular Physiology Including Velocity, Pressure, and Wall Shear Stress
Study Start Date :
Feb 1, 2008
Anticipated Primary Completion Date :
Jan 1, 2025
Anticipated Study Completion Date :
Feb 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Study

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

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.

Normal Volunteers

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

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.

Outcome Measures

Primary Outcome Measures

  1. Wall Shear Stress [20 years]

    Computational parameters derived from clinical diagnostic modalities

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Lucile Packard Children's Hospital at Stanford Palo Alto California United States 94304

Sponsors and Collaborators

  • Stanford University

Investigators

  • Principal Investigator: Jeffrey Feinstein, MD, MPH, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
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
ClinicalTrials.gov Identifier:
NCT03149341
Other Study ID Numbers:
  • SQL 80004
First Posted:
May 11, 2017
Last Update Posted:
Sep 22, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 22, 2021