Magnetic Resonance Elastography of Cardiac Transplant Rejection

Not Applicable

Terminated

• Conditions: Acute Graft Rejection
• Interventions: Device: Magnetic Resonance Elastography driver

• Registration Number: NCT02266914
• Lead Sponsor: Ohio State University

Brief Summary

Magnetic Resonance Elastography (MRE) for cardiac transplant patients.

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 Timeline

• Study Start: 2014-01-27
• Study First Submitted: 2014-09-30
• Study First Submitted QC: 2014-10-13
• Study First Posted: 2014-10-17
• Primary Completion: 2017-12-01
• Study Completion: 2017-12-01
• Results First Submitted: 2019-03-04
• Status Verified: 2019-05
• Results First Submitted QC: 2019-05-21
• Last Update Submitted: 2019-05-21
• Results First Posted: 2019-05-22
• Last Update Posted: 2019-05-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Magnetic Resonance Elastography driver	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.

Primary Outcome Measures

Name	Time	Method
Cardiac Stiffness With Magnetic Resonance Elastography (MRE)	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.

Trial Locations

Locations (1)

The Ohio State University Medical Center; 🇺🇸 Columbus, Ohio, United States