Diagnostic and Therapeutic Applications of Microarrays in Heart Transplantation
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/15/2019 |
| Start Date: | January 2016 |
| End Date: | December 2020 |
| Contact: | Konrad S Famulski, PhD |
| Email: | konrad@ualberta.ca |
| Phone: | 1 7804921725 |
Diagnostic and Therapeutic Applications of Microarrays in Heart Transplantation, a Multicenter Study (INTERHEART)
Demonstrate the impact of the Molecular Microscope Diagnostic System as the standard of care
for heart transplant patients.
for heart transplant patients.
The current standard for biopsy-based diagnoses of rejection of heart transplants is the
ISHLT classification from 2004, which represents a widely-used international consensus, based
on morphological criteria of the cellular infiltrate within the myocardial specimen system
with certainties and some arbitrary and blurred parameters. Recent data-driven approaches
using molecular and conventional technologies indicate that this system produces incorrect
diagnoses with potential harm to patients due to inappropriate treatment. To address this
unmet need and improve diagnostics in the area of organ transplantation, the Alberta
Transplant Applied Genomics Centre (ATAGC, University of Alberta) has developed a new
diagnostic system - the Molecular Microscope™ Diagnostic System (MMDx) that interprets
biopsies in terms of their molecular phenotype, and combines the molecular and
histopathological features of transplant biopsies, plus clinical and laboratory parameters,
to create the first Integrated Diagnostic System. The MMDx developed first in kidney
transplant biopsies because phenotypes are well established, will now be adapted to heart
transplant endomyocardial biopsies (EMBs). The present study will develop a Reference Set of
EMB, adapt the MMDx™ system to assess and report EMBs; and validate and refine this system in
900 unselected prospectively collected for clinical indications and a standard of care EMBs
from North American and European Centers. In addition to demonstrating the real-time
feasibility and potential value of this System in patient care, the study will develop and
optimize a transparent and user-friendly reporting format to communicate this information to
clinicians and obtain detailed feedback to improve its utility. We refine now our MMDx system
using a new type of analysis (see primary outcome) and the resulting MMDx report.
ISHLT classification from 2004, which represents a widely-used international consensus, based
on morphological criteria of the cellular infiltrate within the myocardial specimen system
with certainties and some arbitrary and blurred parameters. Recent data-driven approaches
using molecular and conventional technologies indicate that this system produces incorrect
diagnoses with potential harm to patients due to inappropriate treatment. To address this
unmet need and improve diagnostics in the area of organ transplantation, the Alberta
Transplant Applied Genomics Centre (ATAGC, University of Alberta) has developed a new
diagnostic system - the Molecular Microscope™ Diagnostic System (MMDx) that interprets
biopsies in terms of their molecular phenotype, and combines the molecular and
histopathological features of transplant biopsies, plus clinical and laboratory parameters,
to create the first Integrated Diagnostic System. The MMDx developed first in kidney
transplant biopsies because phenotypes are well established, will now be adapted to heart
transplant endomyocardial biopsies (EMBs). The present study will develop a Reference Set of
EMB, adapt the MMDx™ system to assess and report EMBs; and validate and refine this system in
900 unselected prospectively collected for clinical indications and a standard of care EMBs
from North American and European Centers. In addition to demonstrating the real-time
feasibility and potential value of this System in patient care, the study will develop and
optimize a transparent and user-friendly reporting format to communicate this information to
clinicians and obtain detailed feedback to improve its utility. We refine now our MMDx system
using a new type of analysis (see primary outcome) and the resulting MMDx report.
Inclusion Criteria:
- biopsy for clinical indications
Exclusion Criteria:
- no consent
- pregnant women
We found this trial at
5
sites
Los Angeles, California 90048
Principal Investigator: Jon Kobashigawa, MD
Phone: 310-248-7141
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Darlinghurst, 2010
Principal Investigator: Peter MacDonald, MD
Phone: 61-02-8382-3025
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757 Westwood Plaza
Los Angeles, California 90024
Los Angeles, California 90024
Principal Investigator: Martin Cadeiras, MD
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Richmond, Virginia 23298
Principal Investigator: Keyur B Shah, MD
Phone: 804-682-2452
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Salt Lake City, Utah 84132
Principal Investigator: Josef Stehlik, MD PhD
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