Magnetic Resonance Elastography of Cardiac Transplant Rejection

May 21, 2019 updated by: Richard D. White, M.D.,, Ohio State University
Magnetic Resonance Elastography (MRE) for cardiac transplant patients.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

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
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Medical Center

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: 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.
Other Names:
  • Siemens MRE Driver

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac Stiffness With Magnetic Resonance Elastography (MRE)
Time Frame: 24-48 hours
MRE scans will be performed within 24-48 hours of standard of care cardiac biopsies for patients who have undergone cardiac transplant at The Ohio State University Ross Heart Hospital. Stiffness results from the MRE will be compared to histopathology from the cardiac biopsy to determine if the completely non-invasive MRE can successfully predict transplant rejection.
24-48 hours

Collaborators and Investigators

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

Sponsor

Ohio State University

Investigators

  • Principal Investigator: Richard White, MD, The Ohio State University Medical Center Dept. of Radiology

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 (Actual)

January 27, 2014

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

September 30, 2014

First Submitted That Met QC Criteria

October 13, 2014

First Posted (Estimate)

October 17, 2014

Study Record Updates

Last Update Posted (Actual)

May 22, 2019

Last Update Submitted That Met QC Criteria

May 21, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 2013H0318

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on Acute Graft Rejection

Clinical Trials on Magnetic Resonance Elastography driver

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Panama

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe