Magnetic Resonance Elastography of Cardiac Transplant Rejection

The Ohio State University

Status: Terminated

Conditions: Acute Graft Rejection

Treatments: Device: Magnetic Resonance Elastography driver

Study type: Interventional

Funder types: Other

Identifiers

NCT02266914

2013H0318

Details and patient eligibility

About

Magnetic Resonance Elastography (MRE) for cardiac transplant patients.

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

Arm 1

Experimental group

Description:

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.

Treatment:

Device: Magnetic Resonance Elastography driver