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Sponsored by: |
University of Florida |
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Information provided by: | University of Florida |
ClinicalTrials.gov Identifier: | NCT00365833 |
We believe that certain cells in the human body (Circulating Endothelial Cells and Endothelial Progenitor Cells)are related to risk of cardiovascular disease. It may be possible to measure levels of these cells in patients who have had a kidney transplant and predict their risk of developing cardiovascular disease.
Condition |
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Kidney Transplantation Cardiovascular Abnormalities Cardiovascular Diseases |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Circulating Endothelial Cell and Endothelial Progenitor Cell Evaluation of Kidney Transplant Patients |
Enrollment: | 8 |
Study Start Date: | July 2006 |
Estimated Study Completion Date: | August 2008 |
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 and a reduction of endothelial progenitor cells 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. 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.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
de novo renal transplant recipients
Inclusion Criteria:
Exclusion Criteria:
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 |
Study ID Numbers: | 217-2006 |
Study First Received: | August 17, 2006 |
Last Updated: | June 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00365833 History of Changes |
Health Authority: | United States: Institutional Review Board |
Transplantation Cardiovascular Renal |
Cardiovascular Abnormalities Congenital Abnormalities |
Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities |