Trifecta-Heart cfDNA-MMDX Study: Comparing the DD-cfDNA Test to MMDx Microarray Test and Central HLA Antibody Test
University of Alberta
Summary
Demonstrate the relationship between DD-cfDNA levels and HLA antibodies in blood transplant recipient and the Molecular Microscope® (MMDx) Diagnostic System results in indication and protocol biopsies from heart transplants.
Description
The current standard for assessment of rejection in heart transplants is an endomyocardial biopsy (EMB) interpreted by histology according to ISHLT guidelines. This has considerable error rates, many due to the high disagreement among pathologists in assessing lesions and diagnoses. To address the unmet need for precision and accuracy, the Alberta Transplant Applied Genomics Centre (ATAGC, University of Alberta) has developed a new diagnostic system - the Molecular Microscope® Diagnostic System (MMDx), which uses microarrays to define the global gene expression features of rejection and injury…
Eligibility
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * All heart transplant recipients undergoing a biopsy for clinical indications and protocol biopsies, as determined by their physician or surgeon, will be eligible to enroll in the study. * Patients are enrolled based on standard of care biopsies, including surveillance biopsies in high-risk patients, with informed consent. Exclusion Criteria: * Patients will be excluded from the study if they decline participation * Are unable to give informed consent. * Recipients of multiple organs.
Interventions
- Diagnostic TestMMDx diagnostic test
Microarray test of gene expression in heart biopsies
- Diagnostic TestProspera
Donor derived cell-free DNA in patient blood
- Diagnostic TestHLA antibody
Centralized measurement of HLA antibodies in patient blood
Locations (12)
- Baptist Health Institute for Research and InnovationLittle Rock, Arkansas
- Tampa General Hospital, 409 Bayshore Blvd.Tampa, Florida
- Columbia University Medical Center, Columbia Interventional Cardiovascular CareWest New York, New Jersey
- Montefiore Medical Center, 3319 Rochambeau Avenue, 2nd FLThe Bronx, New York
- Annette C. and Harold C. Simmons Transplant Institute, BaylorScott&White Research InstituteDallas, Texas
- Cardiovascular Medicine, University of Utah HealthSalt Lake City, Utah