Acute Graft Rejection
Conditions
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.
Interventions
DEVICEMagnetic 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.
Sponsors
Ohio State University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment period: January 27, 2014 to December 7, 2014 (approximately 1 year) at The Ohio State University Wexner Medical Center.
Participants by arm
| Arm | Count |
|---|---|
| Cardiac Transplant Patients 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: 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. | 9 |
| Total | 9 |
Baseline characteristics
| Characteristic | Cardiac Transplant Patients |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 9 |
| other Total, other adverse events | 0 / 9 |
| serious Total, serious adverse events | 0 / 9 |
Outcome results
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.
Time frame: 24-48 hours
Population: Data were not collected due to study termination.