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Diagnostic and Therapeutic Applications of Microarrays in Heart Transplantation

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ClinicalTrials.gov Identifier: NCT02670408
Recruitment Status : Recruiting
First Posted : February 1, 2016
Last Update Posted : June 26, 2020
Sponsor:
Information provided by (Responsible Party):
Philip Halloran, University of Alberta

Brief Summary:
Demonstrate the impact of the Molecular Microscope Diagnostic System as the standard of care for heart transplant patients.

Condition or disease Intervention/treatment
Cardiac Transplant Disorder Procedure: Endomyocardial biopsy

Detailed Description:
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. Currently, INTERHEART recruited 1629 biopsies from 792 patients.

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Study Type : Observational
Estimated Enrollment : 900 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diagnostic and Therapeutic Applications of Microarrays in Heart Transplantation, a Multicenter Study (INTERHEART)
Study Start Date : January 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: Endomyocardial biopsy
    One of several endomyocardial biopsy bites taken as the standard of care. We are asking now for two endomyocardial biopsy bites, to determine tissue sampling variability.


Primary Outcome Measures :
  1. Assign molecular scores (probability) of T cell mediated rejection, antibody mediated rejection in heart transplant biopsies, in a reference set of 200 biopsies [ Time Frame: 2 years ]
    Create a molecular classifier that predicts antibody mediated and T cell mediated rejection, based on the archetypal analysis.


Secondary Outcome Measures :
  1. Assign in real time (three working days upon biopsy receipt) molecular scores (probability) of T cell mediated rejection and antibody mediated rejection. [ Time Frame: 1 year ]
    The molecular phenotype of a newly acquired sample predicts the histologic and clinical features of this sample when compared to the reference set.


Biospecimen Retention:   Samples Without DNA
Biopsy extract containing RNA


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study aims to recruit 1200 biopsies from heart transplant patients for clinical indications and the standard of care biopsies.
Criteria

Inclusion Criteria:

  • biopsy for clinical indications

Exclusion Criteria:

  • no consent
  • pregnant women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02670408


Contacts
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Contact: Konrad S Famulski, PhD 1 7804921725 konrad@ualberta.ca
Contact: Robert Polakowski, PhD 1780 492 5091 polakows@ualberta.ca

Locations
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United States, California
Cedars-Sinai Heart Institute Recruiting
Los Angeles, California, United States, 90048
Contact: Brandy Starks, MBA    310-248-7141    email:jon.kobashigawa@cshs.org   
Principal Investigator: Jon Kobashigawa, MD         
UCLA Medical Centre Recruiting
Los Angeles, California, United States, CA 90024
Contact: Eugene DePasquale, MD       EDepasquale@mednet.ucla.edu   
Principal Investigator: Martin Cadeiras, MD         
United States, Utah
Cardiovascular Medicine, University of Utah Health Recruiting
Salt Lake City, Utah, United States, UT 84132
Contact: Josef Stehlik, MD PhD         
Principal Investigator: Josef Stehlik, MD PhD         
United States, Virginia
Virginia Commonwealth University, Division of Cardiology Recruiting
Richmond, Virginia, United States, VA 23298
Contact: Laura H Johnson, BSN RN    804-682-2452      
Principal Investigator: Keyur B Shah, MD         
Australia
Cardiac Transplantation Laboratory, The Victor Chang Cardiac Research Institute Recruiting
Darlinghurst, Australia, NSW 2010
Contact: Carmen Herrera, MD    61-02-8382-3025    peter.macdonal@svha.org.au   
Principal Investigator: Peter MacDonald, MD         
Austria
Department of Cardiac Surgery, Medical University of Vienna Recruiting
Vienna, Austria, A-1090
Contact: Arezu Aliabadi, MD    43-1-40400-5643    arezu.aliabadi@meduniwien.ac.at   
Contact: MD         
Principal Investigator: Andreas Zuckerman, MD         
Canada, Alberta
Alberta Transplant Applied Genomics Center, University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 2E1
Contact: Konrad Famulski, PhD    7804921725    konrad@ualberta.ca   
Principal Investigator: Philip F Halloran, MD PhD         
Division of Cardiology, University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 2R7
Contact: Daniel Kim, MD    1 780-407-7206    dk@ualberta.ca   
Principal Investigator: Daniel Kim, MD         
France
Service de Néphrologie-Dialyse Adultes , Hôpital Necker-Enfants Malades Active, not recruiting
Paris, France, 75015
Italy
Heart Failure and Heart Transplant Unit, University of Bologna Recruiting
Bologna, Italy, 40138
Contact: Laura Borgese    39-380-3577261    Laura.Botgese@gmail.com   
Principal Investigator: Luciano Potena, MD         
Spain
Advanced Heart Failure Transplant Unit Recruiting
La Coruna, Spain
Contact: Zulaika Grille Cancela    34-981-176-540 ext 29 10 19    Zulaika.grille.cancela@sergas.es   
Principal Investigator: Maria G Crespo-Leiro, MD         
Sponsors and Collaborators
University of Alberta
Investigators
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Principal Investigator: Philip F Halloran, MD PhD University of Alberta
Publications of Results:
Other Publications:
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Responsible Party: Philip Halloran, Distinguished Professor, University of Alberta
ClinicalTrials.gov Identifier: NCT02670408    
Other Study ID Numbers: ATAGC 002
First Posted: February 1, 2016    Key Record Dates
Last Update Posted: June 26, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Philip Halloran, University of Alberta:
Heart transplant
global gene expression
molecular diagnostics