Magnetic Resonance Elastography of Cardiac Transplant Rejection

NCT02266914 | Terminated Results

• 1 other identifier: 2013H0318
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

Magnetic Resonance Elastography (MRE) for cardiac transplant patients.

Conditions

Acute Graft Rejection

Outcome Measures

Primary Outcomes (1)

• Cardiac Stiffness With Magnetic Resonance Elastography (MRE)

  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

Study Arms (1)

Arm 1

EXPERIMENTAL

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

Interventions

Magnetic Resonance Elastography driver 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.

Also known as: Siemens MRE Driver

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Results Point of Contact

• Title: Tamara McMath, MPH
• Organization: The Ohio State University Wexner Medical Center

tamara.mcmath@osumc.edu

614-293-8082

Study Officials

• Richard White, MD

  The Ohio State University Medical Center Dept. of Radiology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair, Department of Radiology

Study Record Dates

• First Submitted: September 30, 2014
• First Posted: October 17, 2014
• Study Start: January 27, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: May 22, 2019
• Results First Posted: May 22, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)