Diagnostic and Therapeutic Applications of Microarrays in Heart Transplantation
This observational study is looking at how a new diagnostic system, the Molecular Microscope® Diagnostic System (MMDx), can improve the way doctors diagnose rejection in heart transplant patients. Currently, doctors use a system based on looking at tissue samples under a microscope. This study will compare that method with the MMDx, which uses molecular information from biopsies. The goal is to see if MMDx can provide more accurate diagnoses and help doctors make better treatment decisions. You can join if you are 18 or older and need a heart biopsy for clinical reasons. The study aims to enroll 900 participants and will measure how well MMDx can identify T cell and antibody-mediated rejection in heart transplant biopsies over two years.
- Study design
- This is an observational study involving 900 participants. It is not specified if it is randomized or blinded.
- What's involved
- You would undergo an endomyocardial biopsy, which involves taking two tissue samples instead of the usual one during a standard-of-care procedure.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcomes will be measured at 2 years.
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Diagnostic and Therapeutic Applications of Microarrays in Heart Transplantation
At a glance
Conditions
NCT02670408
Where you'd take part
This study runs at 13 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Alberta Transplant Applied Genomics Center, University of Alberta
Edmonton, Alberta, Canadastudy coordinator listed
Recruiting
Cardiac Transplantation Laboratory, The Victor Chang Cardiac Research Institute
Darlinghurst, Australiastudy coordinator listed
Recruiting
Department of Cardiac Surgery, Medical University of Vienna
Vienna, Austriastudy coordinator listed
Recruiting
Institute for Clinical and Experimental Medicine - IKEM
Prague, Czechiastudy coordinator listed
Recruiting
Advanced Heart Failure Transplant Unit
A Coruña, Spainno site contact published
Completed
Annette C. and Harold C. Simmons Transplant Institute, BaylorScott&White Research Institute
Dallas, Texasno site contact published
Completed
Cardiovascular Medicine, University of Utah Health
Salt Lake City, Utahno site contact published
Completed
Cedars-Sinai Heart Institute
Los Angeles, Californiano site contact published
Completed
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Philip F Halloran, MD PhD · PRINCIPAL_INVESTIGATOR · University of Alberta
Who to contact
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Inclusion
Exclusion
What this trial measures
- Assign molecular scores (probability) of T cell mediated rejection, antibody mediated rejection in heart transplant biopsies, in a reference set of 200 biopsies2 years
Create a molecular classifier that predicts antibody mediated and T cell mediated rejection, based on the archetypal analysis.