MRI and Computational Simulation Cardiology Study

September 15, 2021 updated by: Jeffrey A. Feinstein, Stanford University

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Lucile Packard Children's Hospital at Stanford

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

LPCH and Stanford clinics

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wall Shear Stress
Time Frame: 20 years
Computational parameters derived from clinical diagnostic modalities
20 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Anticipated)

January 1, 2025

Study Completion (Anticipated)

February 1, 2025

Study Registration Dates

First Submitted

May 13, 2014

First Submitted That Met QC Criteria

May 9, 2017

First Posted (Actual)

May 11, 2017

Study Record Updates

Last Update Posted (Actual)

September 22, 2021

Last Update Submitted That Met QC Criteria

September 15, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SQL 80004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Publication

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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