Magnetic Resonance Elastography of Cardiac Transplant Rejection

NCT ID: NCT02266914

Last Updated: 2019-05-22

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-27

Study Completion Date

2017-12-01

Brief Summary

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Magnetic Resonance Elastography (MRE) for cardiac transplant patients.

Detailed Description

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Patient will undergo MRE beginning 4-8 weeks post transplant, then with each scheduled cardiac biopsy through 7-8 months post transplant. Results of the MRE will be compared against results of the cardiac biopsy to determine if the non-invasive MRE can predict cardiac transplant rejection.

Conditions

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Acute Graft Rejection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Arm 1

Patients who have received a cardiac transplant at The Ohio State University Ross Heart Hospital will undergo Magnetic Resonance Elastography (MRE) (using a Magnetic Resonance Elastography driver) within 24-48 hours of standard of care biopsy. Results of both will be compared to determine if MRE can successfully predict cardiac transplant rejection.

Group Type EXPERIMENTAL

Magnetic Resonance Elastography driver

Intervention Type DEVICE

A driver is required for MRE. The driver utilizes sound waves to produce vibrations. Images of these vibrations are captured with Magnetic Resonance scanner to produce images that indicate stiffness in an organ.

Interventions

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Magnetic Resonance Elastography driver

A driver is required for MRE. The driver utilizes sound waves to produce vibrations. Images of these vibrations are captured with Magnetic Resonance scanner to produce images that indicate stiffness in an organ.

Intervention Type DEVICE

Other Intervention Names

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Siemens MRE Driver

Eligibility Criteria

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Inclusion Criteria

* Patients must have undergone cardiac transplantation at the Ohio State University Ross Heart Hospital.
* Patients must be able to lie flat on their back in the scanner for up to 60 minutes
* Patient must be able to hold their breath for up to 15 seconds at a time.

Exclusion Criteria

* Patients who are claustrophobic
* Patients who are pregnant, due to potential risks to the fetus.
* Patients with any unapproved, non-MRI safe metal/devices in their bodies.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ohio State University

OTHER

Sponsor Role lead

Responsible Party

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Richard D. White, M.D.,

Professor and Chair, Department of Radiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Richard White, MD

Role: PRINCIPAL_INVESTIGATOR

The Ohio State University Medical Center Dept. of Radiology

Locations

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The Ohio State University Medical Center

Columbus, Ohio, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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2013H0318

Identifier Type: -

Identifier Source: org_study_id

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