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The researchers are trying to develop a way to measure the risk of transplant rejection with a blood test.
The study will utilize peripheral blood assays collected at time points that are considered standard of care at most institutions. Subjects will have peripheral blood collected at 1 month, 3 months, 6 months, and 12 months after heart transplantation, as well as any for cause time points. These samples will then be used for purposes of developing an RNA-seq based peripheral blood assay in adult heart transplant recipients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heart Transplant Recipients | Heart Transplant Recipients meeting the criteria for enrollment and consented will be followed post transplant for 1 year after enrollment into the study. Blood samples will be obtained at their 1, 3, 6, 12 months and any for cause heart biopsy's obtained. There will be no active intervention for recipients that are enrolled. Results from the samples will not be obtained in real time. |
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| Measure | Description | Time Frame |
|---|---|---|
| RNA-seq based peripheral blood assay in heart transplant recipients | Cases will be reviewed and a subset of the peripheral blood specimens will be sent to Mayo Clinic Laboratories for development of the RNA-seq signature. The number of specimens analyzed will be determined based on the incidence of rejection and the incidence of biopsies for cause needed to develop the signature. | 3 years |
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Inclusion Criteria:
Patients who meet all of the following criteria are eligible for enrollment as study participants:
Exclusion Criteria:
Patients who meet any of these criteria are not eligible for enrollment as study participants:
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Heart Transplant recipients
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| Name | Affiliation | Role |
|---|---|---|
| Naveen Pereira, M.D. | Mayo Clinic | Principal Investigator |
| Mark D Stegall, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Phoenix | Arizona | 85054 | United States | ||
| Mayo Clinic |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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15 ml peripheral Blood samples will be processed for DNA extraction and plasma for RNA seq isolation peripheral blood assay will be obtained at 1, 3, 6, 12 months and for cause.
| Jacksonville |
| Florida |
| 32224 |
| United States |
| Mayo Clinic | Rochester | Minnesota | 559055 | United States |