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Trial record 1 of 1 for:    NCT02670408
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Diagnostic and Therapeutic Applications of Microarrays in Heart Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02670408
Recruitment Status : Recruiting
First Posted : February 1, 2016
Last Update Posted : May 26, 2023
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 1859 biopsies from 1233 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 2024
Estimated Study Completion Date : July 2025

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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.

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 identifier (NCT number): NCT02670408

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Contact: Konrad S Famulski, PhD 1 7804921725
Contact: Robert Polakowski, PhD 1780 492 5091

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United States, California
UCLA Medical Centre Recruiting
Los Angeles, California, United States, 90024
Contact: Eugene DePasquale, MD   
Principal Investigator: Martin Cadeiras, MD         
Cedars-Sinai Heart Institute Recruiting
Los Angeles, California, United States, 90048
Contact: Brandy Starks, MBA    310-248-7141   
Principal Investigator: Jon Kobashigawa, MD         
United States, Utah
Cardiovascular Medicine, University of Utah Health Recruiting
Salt Lake City, Utah, United States, 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, 23298
Contact: Laura H Johnson, BSN RN    804-682-2452      
Principal Investigator: Keyur B Shah, MD         
Cardiac Transplantation Laboratory, The Victor Chang Cardiac Research Institute Recruiting
Darlinghurst, Australia, NSW 2010
Contact: Carmen Herrera, MD    61-02-8382-3025   
Principal Investigator: Peter MacDonald, MD         
Department of Cardiac Surgery, Medical University of Vienna Recruiting
Vienna, Austria, A-1090
Contact: Arezu Aliabadi, MD    43-1-40400-5643   
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   
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   
Principal Investigator: Daniel Kim, MD         
Service de Néphrologie-Dialyse Adultes , Hôpital Necker-Enfants Malades Active, not recruiting
Paris, France, 75015
Heart Failure and Heart Transplant Unit, University of Bologna Recruiting
Bologna, Italy, 40138
Contact: Laura Borgese    39-380-3577261   
Principal Investigator: Luciano Potena, MD         
Advanced Heart Failure Transplant Unit Recruiting
La Coruna, Spain
Contact: Zulaika Grille Cancela    34-981-176-540 ext 29 10 19   
Principal Investigator: Maria G Crespo-Leiro, MD         
Sponsors and Collaborators
University of Alberta
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Principal Investigator: Philip F Halloran, MD PhD University of Alberta
Publications of Results:
Other Publications:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Philip Halloran, Distinguished Professor, University of Alberta Identifier: NCT02670408    
Other Study ID Numbers: ATAGC 002
First Posted: February 1, 2016    Key Record Dates
Last Update Posted: May 26, 2023
Last Verified: May 2023
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