CEC/EPC and Cardiovascular Risk in Renal Transplant Recipients (CEC)

September 28, 2011 updated by: University of Florida

Circulating Endothelial Cell and Endothelial Progenitor Cell Evaluation of Kidney Transplant Patients

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.

Study Overview

Status

Terminated

Conditions

Detailed Description

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

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Florida
  - Gainesville, Florida, United States, 32610
    - University of Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

de novo renal transplant recipients

Description

Inclusion Criteria:

kidney transplant recipients
kidney/pancreas transplant recipients
age 18-80

Exclusion Criteria:

inability to return for follow-up visits
multiple organ transplant other than listed above

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Recipients of Kidney Transplant Patients Transplanted with Live or Deceased Donor's Kidney. Standard of Care treatment pre- and post-transplant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular Risk Profile Time Frame: 24 months	Cardiovascular Risk Profile is defined by calculated Framingham Model	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 months
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.	24 months
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.	24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Investigators

Principal Investigator: Giselle Guerra, MD, University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

February 1, 2007

Study Completion (Actual)

February 1, 2007

Study Registration Dates

First Submitted

August 17, 2006

First Submitted That Met QC Criteria