Click on the video to watch an overview of the IMAGE clinical trial by XDx Chief Medical Officer James Yee, M.D. PhD.*

 

*Note:  The video on the IMAGE Objectives and Study Design does not include any study results.

 

The IMAGE Study is a prospective, multi-center, randomized clinical trial designed to compare the clinical outcomes of heart transplant patients managed with AlloMap^® against conventional endomyocardial biopsy.

 

Primary objective:
The study is designed to test the hypothesis that AlloMap is not inferior to endomyocardial biopsy with respect to clinical outcomes (death, hemodynamic compromise (HDC) with evidence of rejection, or graft dysfunction(i.e. HDC) without evidence of rejection) when used to monitor stable, asymptomatic heart transplant patients.

 

Patient population includes:
• > 600 heart transplant recipients
• Patients ≥ 6 months to ≤ 60 months post-transplant were followed for 2 years

 

Timing:

The study completed at the end of 2009.  Results were first presented by the IMAGE Principal Investigators on April 22nd, 2010 as a "Late-Breaking Clinical Trial" at the ISHLT annual conference in Chicago. For details, click here.

 

For additional information, please visit:

http://clinicaltrials.gov/ct2/show/NCT00351559?term=IMAGE+xdx&rank=1

12 IMAGE Sites and Investigators (Listed Alphabetically)

• Barnes-Jewish Hospital and Washington University
  Greg Ewald, M.D.
• Cleveland Clinic
  Randall Starling, M.D.
• Columbia University Medical Center - New York Presbyterian Hospital
  Mario Deng, M.D.
• Intermountain Healthcare
  A.G. Kfoury, M.D.
  Dale Renlund, M.D.
• Newark Beth Israel Medical Center
  David Baran, M.D.
• Northwestern University
  William Cotts, M.D.
• Saint Luke’s Hospital Kansas City , Mid America Heart Institute
  Andrew Kao, M.D.
• Stanford University School of Medicine
  Hannah Valentine, M.D.
  Michael Pham, M.D. (Palo Alto VA)
• Texas Heart Institute at St. Luke's Episcopal Hospital
  Roberta Bogaev, M.D.
• University of Chicago Medical Center
  Allen Anderson, M.D.
  
• University of Pennsylvania School of Medicine
  Thomas P. Cappola, M.D.
  
• University of Pittsburgh Medical Center
  Jeffrey Teuteberg, M.D.