Magnetic Resonance Elastography of Cardiac Transplant Rejection

Acute Graft Rejection Clinical Trial

Official title:

Magnetic Resonance Elastography of Cardiac Transplant Rejection

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02266914
• Other study ID #: 2013H0318
• Status: Terminated
• Phase: N/A
• Start date: January 27, 2014
• Est. completion date: December 1, 2017

Study information

• Verified date: May 2019
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Magnetic Resonance Elastography (MRE) for cardiac transplant patients.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: December 1, 2017
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Graft Rejection

Intervention

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.

Locations

Country	Name	City	State
United States	The Ohio State University Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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