NCT00351559|Completed
IMAGE: A Comparison of AlloMap Molecular Testing and Traditional Biopsy-based Surveillance for Heart Transplant Rejection
Invasive Monitoring Attenuation Through Gene Expression (IMAGE) Trial
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Invasive Monitoring Attenuation Through Gene Expression (IMAGE) Trial
Sponsor study identifier
interventional
629
1 country
13
Study Start
January 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
October 2009
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2009
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2005
Date type not reportedThis date has not been verified as actual or estimated.
July 11, 2006
Actual (reported)July 13, 2006
Actual (reported)October 2009
Actual (reported)Time from study enrollment to the earliest date of decrease in left ventricle function (left ventricular ejection fraction [LVEF] decrease ≥ 25% from baseline)
Time from study enrollment to the development of clinically overt rejection (heart failure, hemodynamic compromise)
Time from study enrollment to death from any cause
Number of deaths and cause of death
Number of biopsies planned and performed
Time to and number of biopsy-related complications, including bleeding, perforation and tamponade requiring pericardiocentesis, worsening of tricuspid regurgitation (TR) by 1 grade above 2+ or new TR at least 3+ or greater
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
VA Palo Alto Health Care System
Palo Alto, California, 94304, United States
Stanford University Medical Center
Stanford, California, 94305, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Chicago
Chicago, Illinois, 60637, United States
Mid America Heart Institute - St. Luke's Hospital
Kansas City, Missouri, 64111, United States
Barnes Jewish Hospital - Washington University
St Louis, Missouri, 63110, United States
Newark Beth Israel Medical Center
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.
Hannah A Valantine, MD, MRCP, FACC
Stanford University
Michael Pham, MD, MPH
VA Palo Alto Health Care System
Mario C Deng, MD
Columbia University, New York Presbyterian Hospital
Jeffrey J Teuteberg, MD
University of Pittsburgh Medical Center
629 participants (actual enrollment reported by the registry).
First Submitted
July 11, 2006
First Posted
July 13, 2006
Study Start
January 2005
Date type not reportedThis date has not been verified as actual or estimated.
D2-EPG Study: Evaluation of New Sensing Circuitry and Capture Management
Contact the study team to confirm eligibility.
Newark, New Jersey, 07112, United States
Columbia University Medical Center - New York Presbyterian Hospital
New York, New York, 10032, United States
The Cleveland Clinic
Cleveland, Ohio, 44195, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Texas Heart Institute at St. Luke's Episcopal Hospital
Houston, Texas, 77030, United States
Intermountain Medical Center
Murray, Utah, 84157, United States
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.
A G Kfoury, MD
Intermountain Health Care, Inc.
Dale G Renlund, MD
Intermountain Health Care, Inc.
Randall C Starling, MD, MPH
The Cleveland Clinic
Allen Anderson, MD
University of Chicago
Thomas Cappola, MD, ScM
University of Pennsylvania
Andrew Kao, MD
Mid America Heart Institute - St. Luke's Hospital
William G Cotts, MD
Northwestern University
Roberta C Bogaev, M.D., FACC, FACP
Texas Heart Institute at St. Luke's Episcopal Hospital
David Baran, MD
Newark Beth Israel Medical Center
Greg Ewald, MD
Barnes-Jewish Hospital
Study Completion
October 2009
Actual (reported)Last Updated
November 20, 2009
Record last verified: 2009-11
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Source: ClinicalTrials.gov.
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