Diagnostic and Therapeutic Applications of Microarrays in Heart Transplantation

NCT02670408 · tracked via the Priya Life Science Italy tracker

Sponsor

University of Alberta

Phase

Observational

Started

2016-01

Last updated

2026-06-04

Condition(s) studied

Cardiac Transplant Disorder

Investigational drug(s) / intervention(s)

Endomyocardial biopsy

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.

Study summary

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

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * biopsy for clinical indications Exclusion Criteria: * no consent * pregnant women

Primary outcome measure(s)

Assign molecular scores (probability) of T cell mediated rejection, antibody mediated rejection in heart transplant biopsies, in a reference set of 200 biopsies — 2 years
Create a molecular classifier that predicts antibody mediated and T cell mediated rejection, based on the archetypal analysis.

Trial sites (13)

Facility	City	Region	Status
UCLA Medical Centre	Los Angeles	California	Completed
Cedars-Sinai Heart Institute	Los Angeles	California	Completed
Annette C. and Harold C. Simmons Transplant Institute, BaylorScott&White Research Institute	Dallas	Texas	Completed
Cardiovascular Medicine, University of Utah Health	Salt Lake City	Utah	Completed
Virginia Commonwealth University, Division of Cardiology	Richmond	Virginia	Completed
Cardiac Transplantation Laboratory, The Victor Chang Cardiac Research Institute	Darlinghurst	Australia	Recruiting
Department of Cardiac Surgery, Medical University of Vienna	Vienna	Austria	Recruiting
Alberta Transplant Applied Genomics Center, University of Alberta	Edmonton	Alberta	Recruiting
Division of Cardiology, University of Alberta	Edmonton	Alberta	Completed
Institute for Clinical and Experimental Medicine - IKEM	Prague	Czechia	Recruiting
Service de Néphrologie-Dialyse Adultes , Hôpital Necker-Enfants Malades	Paris	France	Completed
Heart Failure and Heart Transplant Unit, University of Bologna	Bologna	Italy	Completed
Advanced Heart Failure Transplant Unit	A Coruña	Spain	Completed

More University of Alberta trials in Italy

Micro-UltraSound In Cancer - Active Surveillance Active, not recruiting

Trifecta-Heart cfDNA-MMDx Study Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02670408 on ClinicalTrials.gov ↗ ← All trials in Italy