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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00962377
Recruitment Status : Unknown
Verified December 2010 by XDx.
Recruitment status was:  Active, not recruiting
First Posted : August 20, 2009
Last Update Posted : December 21, 2010
Information provided by:

Brief 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.

Condition or disease Intervention/treatment Phase
Graft Rejection Heart Diseases Procedure: Endomyocardial biopsy Procedure: AlloMap Molecular Testing Not Applicable

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. 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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Early Invasive Monitoring Attenuation Through Gene Expression (EIMAGE) Trial
Study Start Date : August 2009
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
AlloMap Molecular testing
Gene expression profiling in the 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.
Other Name: GEP

Active Comparator: Endomyocardial biopsy
Right ventricular endomyocardial biopsy in the monitoring of asymptomatic heart transplant patients for acute cellular rejection
Procedure: Endomyocardial biopsy
Right ventricular endomyocardial biopsy in monitoring of asymptomatic heart transplant patients for acute cellular rejection
Other Name: EMB

Primary Outcome Measures :
  1. Event-Free Survival and intravascular ultrasound (IVUS) measures [ Time Frame: 1.5 years ]

    Event-Free Survival (EFS) is a composite of: the development of hemodynamic compromise with rejection, allograft dysfunction (hemodynamic compromise without histologically confirmed rejection), death from any cause, or re-transplantation.

    IVUS co-primary endpoint: maximal intimal thickness of the coronary arteries from baseline (measured at 6 weeks ± 30 days) to month 12 of ≥0.5mm, as measured by IVUS.

Secondary Outcome Measures :
  1. Time from enrollment to death from any cause, and cause of death. [ Time Frame: 1.5 years ]
  2. Number of biopsies performed. [ Time Frame: 1.5 years ]
  3. Time from study enrollment to biopsy-related complications, as well as the number and type of biopsy-related complications. [ Time Frame: 1.5 years ]
  4. QOL responses as collected from the SF-12 form [ Time Frame: Enrollment and one year post-transplant ]
  5. Biopsy-related patient preferences satisfaction using a non-validated survey [ Time Frame: Enrollment and one year post transplant ]
  6. Objective measurements of cardiac function [ Time Frame: 1.5 years ]
  7. Gene expression profiling scores and immunosuppressant doses [ Time Frame: 1.5 years ]
  8. Number of rejection episodes. [ Time Frame: 1.5 years ]
  9. Utilization of AlloMap or biopsy to manage corticosteroid weaning between month 6 and month 12 post-transplant. [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Heart transplant recipients who are 2-6 months (≥55 days -185 days) post-transplant at the time of the first study surveillance visit
  2. Age ≥ 18 years
  3. Left ventricular ejection fraction ≥ 50% by Echocardiography, Multiple Gated Acquisition (MUGA) scan, or ventriculography at study entry (baseline / enrollment study)

Exclusion Criteria:

  1. Any clinical signs of declining graft function:

    • Symptoms of Congestive Heart Failure (CHF) at the first study surveillance visit
    • Signs of decompensated heart failure, including the development of a new S3 gallop at the enrollment visit
    • Elevated right heart pressures with diminished cardiac index < 2.2 L/min/m2 that is new compared to a previous measurement within 2 months
    • Decrease in LVEF as measured by echocardiography: ≥ 25% compared to prior measurement within 2 months
  2. Rejection therapy for biopsy-proven ISHLT Grade 3A or higher during the preceding 2 months
  3. Prior or current evidence of antibody-mediated rejection (AMR). AMR is defined according to the ISHLT 2004 Guidelines as positive histology and immunopathology (either immunofluorescence or immunoperoxidase) staining for AMR
  4. Major changes in immunosuppression therapy within previous 30 days (e.g., discontinuation of calcineurin inhibitors, switch from mycophenolate mofetil to sirolimus or vice versa)
  5. Unable to give written informed consent
  6. Patient receiving hematopoietic growth factors (e.g., Neupogen, Epogen) currently or during the previous 30 days
  7. Patients receiving ≥ 20 mg/day of prednisone equivalent corticosteroids at the time of first study surveillance visit
  8. Patient enrolled in a trial requiring routine surveillance endomyocardial biopsies
  9. Patient received transfusion within preceding 4 weeks
  10. Patients with end-stage renal disease requiring some form of renal replacement therapy (hemodialysis or peritoneal dialysis)
  11. Pregnancy at the time of first study surveillance visit

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00962377

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United States, California
Cedars-Sinai Medical Center
Beverly Hills, California, United States, 90211
Sponsors and Collaborators
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Study Director: Upen Patil, MD XDx, Inc.
Publications of Results:
Other Publications:
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Responsible Party: Debbie Pieretti, Sr. Director Clinical Operations, XDx, Inc. Identifier: NCT00962377    
Other Study ID Numbers: CA-0007
First Posted: August 20, 2009    Key Record Dates
Last Update Posted: December 21, 2010
Last Verified: December 2010
Keywords provided by XDx:
molecular expression testing
right ventricular endomyocardial biopsy
Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases