A major cause of heart transplant failure is the blockage of blood flow from lesions caused by ongoing injury and repair of the graft by the host's immune system. However, the role of T cells, antibodies, and other parts of the recipient's immune system are not well understood in transplant injury. Currently, there are no effective, noninvasive ways to detect or predict how an individual's immune system will react to a transplant. The purpose of this study is to correlate current noninvasive monitoring tests with long-term graft survival and function, and determine which tests are the most accurate predictors of this survival.

instance of dataset

2 - Complete set of descriptive data and results, as ascertained by ImmPort.

available with registration

The objective of this prospective observational study is to determine whether any single monitoring test or a combination of monitoring tests, obtained during the first year after cardiac transplantation is associated with the primary composite endpoint consisting of death, re-transplantation or re-listed for transplant, biopsy proven acute rejection >=2R, any episode of rejection associated with hemodynamic compromise, or cardiac transplant allograft vasculopathy as defined by an increase in maximum intimal thickness (MIT) >=0.5 mm between study entry and 12 months.

registration required

Cardiac Transplantation

Peter Heeger

Mohamed Sayegh

Ricanati Miller Transplant Institute, Mount Sinai School of Medicine

Brigham and Women's Hospital, Harvard Medical School

principal investigator

Observational Study of Alloimmunity in Cardiac Transplant Recipients (CTOT-05)

200

NONINVASIVE MARKERS AND TRANSPLANT OUTCOME IN HUMANS (CTOT-01, CTOT-05)

The primary endpoint of this study is a composite of incidence of the following at 12 months after study enrollment: death, re-transplantation or re-listed for transplantation, biopsy proven acute rejection (BPAR) of >= 2R, episode of rejection associated with hemodynamic compromise, and coronary artery vasculopathy defined by a change in MIT of >=0.5 mm between study entry and 12 months. The secondary endpoints of this study are: individual components of the primary composite endpoints at 12 months, incidence of death at 6 months, incidence of re-transplantation or re-listed at 6 months, incidence of BPAR (any grade) at 6 months, number of episodes of BPAR (any grade) per subject at 6, and 12 months, proportion of subjects with a change in mean intimal thickness of >0.5 mm from study entry until 12 months plus the proportion of subjects with significant diffuse CAD that prevents IVUS procedure, change in average MIT from study entry to 12 months, MIT, luminal area, intimal area, percent stenosis (intimal index), and initial volume (volumetric analysis) as measured by IVUS, decrement in GFR of >30% between study entry and 12 months.

Heart Transplant Recipients: Subjects who will have a heart transplant

The purpose of this study is to identify a single test or a combination of noninvasive tests currently used for heart transplant monitoring that correlate to long-term graft survival.

10.21430/M3AG2C6125

2007-06-01

ImmPort

SCR:012804