CEC/EPC and Cardiovascular Risk in Renal Transplant Recipients (CEC)
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|ClinicalTrials.gov Identifier: NCT00365833|
Recruitment Status : Terminated (difficulty obtaining required data)
First Posted : August 18, 2006
Last Update Posted : September 30, 2011
|Condition or disease|
|Transplantation, Kidney Cardiovascular Abnormalities Cardiovascular Diseases|
Coronary disease is one of the most common causes of morbidity and mortality in patients with known chronic renal insufficiency and those with end stage renal disease. Consequently, early detection with markers such as circulating endothelial cells and endothelial progenitor cells has been studied in order to identify vascular function and assess overall cardiovascular risk. Based on current research, there exists a notable increase in Circulating Endothelial Cells (CEC) and a reduction of Endothelial Progenitor Cells (EPC) with renal dysfunction due to endothelial damage. Therefore circulating endothelial cells are a marker for cardiovascular health.
Renal transplant patients also possess a higher cardiovascular risk than the general population, but have known improvement in survival as compared to patients with ESRD (End Stage Renal Disease). In addition, because of the excellent outcomes, graft and patient survival and even acute rejection are no longer very useful endpoints for clinical studies. The tolerability of transplant drug regimens and the impact of these regimes on cardiovascular health in kidney transplantation has become, consequently, a new focus of research. Currently, no clear long-term analysis has been fulfilled analyzing CEC or EPC in this group of patients. We hypothesize that CEC can serve as biological markers for cardiovascular risk assessment in cadaveric and living renal transplant patients. We eventually hope measurement of these cells can serve as an endpoint in determining cardiovascular outcome in renal transplant patients. Our present study is aimed to get an initial assessment of the kinetics of CEC and EPC in renal transplant recipients just prior to transplant and for the first two years post transplant.
|Study Type :||Observational|
|Actual Enrollment :||8 participants|
|Official Title:||Circulating Endothelial Cell and Endothelial Progenitor Cell Evaluation of Kidney Transplant Patients|
|Study Start Date :||July 2006|
|Primary Completion Date :||February 2007|
|Study Completion Date :||February 2007|
Recipients of Kidney Transplant
Patients Transplanted with Live or Deceased Donor's Kidney. Standard of Care treatment pre- and post-transplant.
- Cardiovascular Risk Profile [ Time Frame: 24 months ]Cardiovascular Risk Profile is defined by calculated Framingham Model
- Rate of Cardiovascular Events Post-Transplant [ Time Frame: 24 months ]Measured by Kaplan-Meier analysis and Cox Proportional Hazard Models to correlate CEC and EPC to this outcome.
- Rate of Patient Survival Post-Transplant [ Time Frame: 24 months ]Measured by Kaplan-Meier analysis and Cox Proportional Hazard Models to correlate CEC and EPC to this outcome.
- Rate of Graft Survival Post-Transplant [ Time Frame: 24 months ]Measured by Kaplan-Meier analysis and Cox Proportional Hazard Models to correlate CEC and EPC to this outcome.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00365833
|United States, Florida|
|University of Florida|
|Gainesville, Florida, United States, 32610|
|Principal Investigator:||Herwig-Ulf Meier-Kriesche, md||University of Florida|
|Principal Investigator:||Giselle Guerra, MD||University of Florida|