Molecular testing for long-term rejection surveillance in heart transplant recipients: design of the Invasive Monitoring Attenuation Through Gene Expression (IMAGE) trial
| Autor: | Abdallah G. Kfoury, Jeffrey J. Teuteberg, Randall C. Starling, Mario C. Deng, Hannah A. Valantine, M.X. Pham |
|---|---|
| Rok vydání: | 2007 |
| Předmět: |
Pulmonary and Respiratory Medicine
Graft Rejection medicine.medical_specialty Time Factors Acute cellular rejection Gene Expression Image Study Severity of Illness Index law.invention Diagnosis Differential Randomized controlled trial law Internal medicine Cause of Death medicine Humans Transplantation Homologous Prospective Studies Monitoring Physiologic Transplantation Cardiac allograft business.industry Gene Expression Profiling Incidence Myocardium Reproducibility of Results Surgery Clinical trial Survival Rate Molecular Diagnostic Techniques Allograft rejection Echocardiography Heart Transplantation Transplant patient Cardiology and Cardiovascular Medicine business Follow-Up Studies |
| Zdroj: | The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation. 26(8) |
| ISSN: | 1557-3117 |
| Popis: | Background Acute rejection continues to occur beyond the first year after cardiac transplantation, but the optimal strategy for detecting rejection during this late period is still controversial. Gene expression profiling (GEP), with its high negative predictive value 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). Methods The Invasive Monitoring Attenuation Through Gene Expression (IMAGE) study is a prospective, multicenter, non-blinded, randomized clinical trial designed to test the hypothesis that a primarily non-invasive rejection surveillance strategy utilizing GEP testing is not inferior to an invasive EMB-based strategy with respect to cardiac allograft dysfunction, rejection with hemodynamic compromise (HDC) and all-cause mortality. Results A total of 199 heart transplant recipients in their second through fifth post-transplant years have been enrolled in the IMAGE study since January 13, 2005. The study is expected to continue through 2008. Conclusions The IMAGE study is the first randomized, controlled comparison of two rejection surveillance strategies measuring outcomes in heart transplant recipients who are beyond their first year post-transplant. The move away from routine histologic evaluation for allograft rejection represents an important paradigm shift in cardiac transplantation, and the results of this study have important implications for the future management of heart transplant patients. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|