Heart Diseases Clinical Trial
Official title:
Early Invasive Monitoring Attenuation Through Gene Expression (EIMAGE) Trial
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.
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. 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).
The Invasive Monitoring Attenuation through Gene Expression (IMAGE) multicenter study was
conducted between the years 2005-2009 and studied patients who were >6 months-5 years post
transplant. The IMAGE study demonstrated that the clinical outcome of heart transplant
patients managed with AlloMap® was noninferior to patients managed with EMB. The EIMAGE
study expands the time window under study to include patients who are 2 months (≥ 55 days)
post-transplant. This earlier time frame of study is the primary difference between the
EIMAGE study and the IMAGE study.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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