Trial record 1 of 1 for:
NCT02670408
Diagnostic and Therapeutic Applications of Microarrays in Heart Transplantation
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| ClinicalTrials.gov Identifier: NCT02670408 |
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Recruitment Status :
Recruiting
First Posted : February 1, 2016
Last Update Posted : May 26, 2023
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Sponsor:
University of Alberta
Information provided by (Responsible Party):
Philip Halloran, University of Alberta
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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 |
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.
| 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 :
- 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 :
- 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
| Contact: Konrad S Famulski, PhD | 1 7804921725 | konrad@ualberta.ca | |
| Contact: Robert Polakowski, PhD | 1780 492 5091 | polakows@ualberta.ca |
Locations
| United States, California | |
| UCLA Medical Centre | Recruiting |
| Los Angeles, California, United States, 90024 | |
| Contact: Eugene DePasquale, MD EDepasquale@mednet.ucla.edu | |
| Principal Investigator: Martin Cadeiras, MD | |
| 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 | |
| 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 | |
| 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.borgese@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
| Principal Investigator: | Philip F Halloran, MD PhD | University of Alberta |
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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: | 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:
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Heart transplant global gene expression molecular diagnostics |