Heart Clinical Trials
INTERHEART Trial Summary
The current standard for histologic diagnosis of heart transplant endomyocardial biopsies (EMBs) uses The International Society for Heart & Lung Transplantation (ISHLT) classification, which has limited interobserver reproducibility (3). To improve biopsy assessment, the Alberta Transplant Applied Genomics Centre (ATAGC) adapted the Molecular Microscope developed in kidney transplant biopsies to heart transplant endomyocardial biopsies (EMBs) in the INTERHEART study. The molecular phenotype of ABMR in heart transplants is remarkably similar to that in kidney transplants (17). This permits us to use kidney rejection-associated transcripts to classify heart transplant biopsies. The first generation Molecular Microscope system, evaluated in EMBs from Paris, Edmonton, and Bologna, has been published (18). Two major publications are under review (19;20).
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Study
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Distinguish injury from rejection.
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Expand the Reference Set for heart transplants (EMBs) with molecular, histologic, DSA, and clinical data.
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Develop the Molecular Microscope report for EMBs, incorporating rejection and injury transcripts discovered in kidney.
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Validate and refine the system by reporting in real time (<48 hours from receiving the biopsy) 1000 new heart biopsies and obtain feedback from KOL clinicians. This involves unselected, prospectively collected, standard-of-care EMBs from North American, European, and Australian Centers.
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Develop and optimize a transparent and user- friendly reporting format to communicate this information to clinicians.
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The MMDx-Heart report will express rejection as archetype scores for probability of ABMR, TCMR and non-rejection, with the scores adding up to 1.0
Sample Reports
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Kidney Severe ABMR page 1
Kidney Severe ABMR page 2
Kidney Severe ABMR page 1