IMAGE: A Comparison of AlloMap Molecular Testing and Traditional Biopsy-based Surveillance for Heart Transplant Rejection

Summary

This study is designed to evaluate the safety and efficacy of a leukocyte gene expression profiling method in the monitoring of asymptomatic heart transplant patients for acute rejection.

Conditions

• Graft Rejection
• Heart Diseases

Interventions

DEVICE

AlloMap molecular expression testing

PROCEDURE

Right ventricular endomyocardial biopsy

Sponsors & Collaborators

• XDx

  lead INDUSTRY

Principal Investigators

• Hannah A Valantine, MD, MRCP, FACC · Stanford University

• Michael Pham, MD, MPH · VA Palo Alto Health Care System

• Mario C Deng, MD · Columbia University, New York Presbyterian Hospital

• Jeffrey J Teuteberg, MD · University of Pittsburgh Medical Center

• A G Kfoury, MD · Intermountain Medical Center

• Dale G Renlund, MD · Intermountain Medical Center

• Randall C Starling, MD, MPH · The Cleveland Clinic

• Allen Anderson, MD · University of Chicago

• Thomas Cappola, MD, ScM · University of Pennsylvania

• Andrew Kao, MD · Mid America Heart Institute - St. Luke's Hospital

• William G Cotts, MD · Northwestern University

• Roberta C Bogaev, M.D., FACC, FACP · Texas Heart Institute at St. Luke's Episcopal Hospital

• David Baran, MD · Newark Beth Israel Medical Center

• Greg Ewald, MD · Barnes-Jewish Hospital

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2005-01-31

Completion

2009-10-31

Countries

• United States

Study Locations