This trial is active, not recruiting.

Condition acute graft rejection
Treatment magnetic resonance elastography driver
Sponsor Ohio State University
Start date June 2014
End date December 2017
Trial size 10 participants
Trial identifier NCT02266914, 2013H0318


Magnetic Resonance Elastography (MRE) for cardiac transplant patients.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose diagnostic
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.
magnetic resonance elastography driver Siemens MRE 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.

Primary Outcomes

Assess cardiac stiffness with Magnetic Resonance Elastography to determine cardiac transplant rejection
time frame: Up to 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Magnetic Resonance Elastography of Cardiac Transplant Rejection
Principal investigator Richard White, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Ohio State University.