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Magnetic Resonance Elastography (MRE) for cardiac transplant patients.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic Resonance Elastography driver | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard White, MD | The Ohio State University Medical Center Dept. of Radiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
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Recruitment period: January 27, 2014 to December 7, 2014 (approximately 1 year) at The Ohio State University Wexner Medical Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Data were not collected due to study termination. | Posted | 24-48 hours |
|
1 year.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tamara McMath, MPH | The Ohio State University Wexner Medical Center | 614-293-8082 | tamara.mcmath@osumc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 18, 2015 | Mar 1, 2019 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 27, 2014 | Mar 1, 2019 | ICF_001.pdf |
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|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
| 1 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
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