IMAGE: A Comparison of AlloMap Molecular Testing and Traditional Biopsy-based Surveillance for Heart Transplant Rejection
NCT ID: NCT00351559
Last Updated: 2009-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
629 participants
INTERVENTIONAL
2005-01-31
2009-10-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Interventions
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AlloMap molecular expression testing
Right ventricular endomyocardial biopsy
Eligibility Criteria
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Inclusion Criteria
2. Age ≥ 18 years.
3. Stable outpatient being seen for routine monitoring of rejection. Stability is defined as absence of prior or current evidence of either severe cardiac allograft vasculopathy (CAV) or antibody-mediated rejection (AMR) with associated hemodynamic compromise.
1. Severe CAV is defined as either
* \> 50% left main stenosis;
* ≥ 50% stenosis in ≥ 2 primary vessels (proximal 1/3 or middle 1/3 of the LAD or LCx, RCA to takeoff of PDA in right-dominant coronary circulations) or
* Isolated branch stenoses of \> 50% in all 3 systems (diagonal branches, obtuse marginal branches, distal 1/3 of LAD or LCx, PDA, PLB, and RCA to takeoff of PDA in non-dominant systems).
2. AMR with associated hemodynamic compromise is defined as AMR (defined according to local criteria) with either
* A left ventricular ejection fraction (LVEF) ≤ 30% or at least 25% lower than the baseline value,
* A cardiac index \< 2 l/min/m2, or
* The use of inotropic agents to support circulation.
4. Left ventricular ejection fraction ≥ 45% by Echocardiography, Multiple Gated Acquisition (MUGA) scan, or ventriculography at study entry (baseline / enrollment study).
Exclusion Criteria
2. Any clinical signs of declining graft function:
1. Symptoms of Congestive Heart Failure (CHF) at the enrollment visit.
2. Signs of decompensated heart failure, including the development of a new S3 gallop at the enrollment visit.
3. Elevated right heart pressures with diminished cardiac index \< 2.2 L/min/m2 that is new compared to a previous measurement within 6 months.
4. Decrease in LVEF as measured by echocardiography: ≥ 25% compared to prior measurement within 6 months.
3. Rejection therapy for biopsy-proven ISHLT Grade 3A or higher during the preceding 2 months.
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 enrollment.
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 enrollment.
18 Years
ALL
No
Sponsors
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XDx
INDUSTRY
Principal Investigators
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Hannah A Valantine, MD, MRCP, FACC
Role: STUDY_CHAIR
Stanford University
Michael Pham, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
VA Palo Alto Health Care System
Mario C Deng, MD
Role: PRINCIPAL_INVESTIGATOR
Columbia University, New York Presbyterian Hospital
Jeffrey J Teuteberg, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh Medical Center
A G Kfoury, MD
Role: PRINCIPAL_INVESTIGATOR
Intermountain Medical Center
Dale G Renlund, MD
Role: PRINCIPAL_INVESTIGATOR
Intermountain Medical Center
Randall C Starling, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Allen Anderson, MD
Role: PRINCIPAL_INVESTIGATOR
University of Chicago
Thomas Cappola, MD, ScM
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Andrew Kao, MD
Role: PRINCIPAL_INVESTIGATOR
Mid America Heart Institute - St. Luke's Hospital
William G Cotts, MD
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Roberta C Bogaev, M.D., FACC, FACP
Role: PRINCIPAL_INVESTIGATOR
Texas Heart Institute at St. Luke's Episcopal Hospital
David Baran, MD
Role: PRINCIPAL_INVESTIGATOR
Newark Beth Israel Medical Center
Greg Ewald, MD
Role: PRINCIPAL_INVESTIGATOR
Barnes-Jewish Hospital
Locations
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VA Palo Alto Health Care System
Palo Alto, California, United States
Stanford University Medical Center
Stanford, California, United States
Northwestern University
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Mid America Heart Institute - St. Luke's Hospital
Kansas City, Missouri, United States
Barnes Jewish Hospital - Washington University
St Louis, Missouri, United States
Newark Beth Israel Medical Center
Newark, New Jersey, United States
Columbia University Medical Center - New York Presbyterian Hospital
New York, New York, United States
The Cleveland Clinic
Cleveland, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Texas Heart Institute at St. Luke's Episcopal Hospital
Houston, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
Countries
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References
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Deng MC, Eisen HJ, Mehra MR, Billingham M, Marboe CC, Berry G, Kobashigawa J, Johnson FL, Starling RC, Murali S, Pauly DF, Baron H, Wohlgemuth JG, Woodward RN, Klingler TM, Walther D, Lal PG, Rosenberg S, Hunt S; CARGO Investigators. Noninvasive discrimination of rejection in cardiac allograft recipients using gene expression profiling. Am J Transplant. 2006 Jan;6(1):150-60. doi: 10.1111/j.1600-6143.2005.01175.x.
Evans RW, Williams GE, Baron HM, Deng MC, Eisen HJ, Hunt SA, Khan MM, Kobashigawa JA, Marton EN, Mehra MR, Mital SR. The economic implications of noninvasive molecular testing for cardiac allograft rejection. Am J Transplant. 2005 Jun;5(6):1553-8. doi: 10.1111/j.1600-6143.2005.00869.x.
Marboe CC, Billingham M, Eisen H, Deng MC, Baron H, Mehra M, Hunt S, Wohlgemuth J, Mahmood I, Prentice J, Berry G. Nodular endocardial infiltrates (Quilty lesions) cause significant variability in diagnosis of ISHLT Grade 2 and 3A rejection in cardiac allograft recipients. J Heart Lung Transplant. 2005 Jul;24(7 Suppl):S219-26. doi: 10.1016/j.healun.2005.04.001.
Pham MX, Deng MC, Kfoury AG, Teuteberg JJ, Starling RC, Valantine H. Molecular testing for long-term rejection surveillance in heart transplant recipients: design of the Invasive Monitoring Attenuation Through Gene Expression (IMAGE) trial. J Heart Lung Transplant. 2007 Aug;26(8):808-14. doi: 10.1016/j.healun.2007.05.017.
Deng MC, Elashoff B, Pham MX, Teuteberg JJ, Kfoury AG, Starling RC, Cappola TP, Kao A, Anderson AS, Cotts WG, Ewald GA, Baran DA, Bogaev RC, Shahzad K, Hiller D, Yee J, Valantine HA; IMAGE Study Group. Utility of gene expression profiling score variability to predict clinical events in heart transplant recipients. Transplantation. 2014 Mar 27;97(6):708-14. doi: 10.1097/01.TP.0000443897.29951.cf.
Pham MX, Teuteberg JJ, Kfoury AG, Starling RC, Deng MC, Cappola TP, Kao A, Anderson AS, Cotts WG, Ewald GA, Baran DA, Bogaev RC, Elashoff B, Baron H, Yee J, Valantine HA; IMAGE Study Group. Gene-expression profiling for rejection surveillance after cardiac transplantation. N Engl J Med. 2010 May 20;362(20):1890-900. doi: 10.1056/NEJMoa0912965. Epub 2010 Apr 22.
Related Links
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Sponsor's web site
Other Identifiers
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CA-0004
Identifier Type: -
Identifier Source: org_study_id