NCT00351559

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

Invasive Monitoring Attenuation Through Gene Expression (IMAGE) Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 629 (actual)
• Sponsor: XDx · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Cardiac allograft rejection is experienced by 20-50% of patients at least once during the first year after cardiac transplantation under the present immunosuppression regimens. With a higher incidence of acute cellular rejection (ACR) in the first six months post-transplant, ACR continues to occur beyond the first year post-transplant. However, the optimal strategy for detecting rejection during this period of lower risk period for ACR is still controversial. The standard for rejection surveillance has been the endomyocardial biopsy (EMB). However, EMB is invasive, causes morbidity, and is subject to sampling error and inter-observer variability. Gene expression profiling (GEP), with its high negative predictive value (NPV) for acute cellular rejection (ACR), appears to be well suited to identify low-risk patients who can be safely managed without routine invasive endomyocardial biopsy (EMB).

Conditions

• Graft Rejection
• Heart Diseases

Interventions

Type	Name	Description
DEVICE	AlloMap molecular expression testing
PROCEDURE	Right ventricular endomyocardial biopsy

Timeline

• Start date: 2005-01-01
• Completion: 2009-10-01
• First posted: 2006-07-13
• Last updated: 2009-11-20

Locations

13 sites across 1 country: United States