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MRI and Computational Simulation Cardiology Study

NCT ID: NCT03149341

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-02-29

Study Completion Date

2029-02-28

Brief Summary

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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

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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.

Conditions

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Congenital Heart Disease Pulmonary Hypertension

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Study

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

Magnetic Resonance Imaging

Intervention Type OTHER

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

Magnetic Resonance Imaging

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeffrey Feinstein, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Lucile Packard Children's Hospital at Stanford

Palo Alto, California, United States

Site Status

Countries

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United States

Other Identifiers

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SQL 80004

Identifier Type: -

Identifier Source: org_study_id