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A Comparison of AlloMap Molecular Testing and Traditional Biopsy-based Surveillance for Heart Transplant Rejection Early Post-transplantation

NCT00962377 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2010-12-21

No results posted yet for this study

Summary

This study is designed to evaluate the safety and efficacy of a peripheral blood mononuclear cell gene expression profiling method (AlloMap) in monitoring asymptomatic heart transplant patients for acute rejection beginning 2-6 months(≥ 55-185 days) after transplantation.

Conditions

  • Graft Rejection
  • Heart Diseases

Interventions

PROCEDURE

Endomyocardial biopsy

Right ventricular endomyocardial biopsy in monitoring of asymptomatic heart transplant patients for acute cellular rejection

PROCEDURE

AlloMap Molecular Testing

Gene expression profiling in the monitoring of asymptomatic heart transplant patients for acute cellular rejection.

Sponsors & Collaborators

  • XDx

    lead INDUSTRY

Principal Investigators

  • Upen Patil, MD · XDx, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00962377 on ClinicalTrials.gov