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Clinical Trials/NCT00374595
NCT00374595
Completed
Not Applicable

Vascular Risk After Kidney Transplantation

University of Nebraska1 site in 1 country338 target enrollmentApril 2006

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiovascular Disease
Sponsor
University of Nebraska
Enrollment
338
Locations
1
Primary Endpoint
Carotid Intima Media Thickness (CIMT)
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Hypothesis: Nontraditional risk factors, such as inflammation, vitamin D deficiency, elevated PTH, insulin resistance, homocysteine, or uric acid, contribute to cardiovascular disease progression after kidney transplant.

The purpose of this study is to evaluate which traditional and nontraditional cardiovascular disease risk factors best predict progression of cardiovascular disease (CVD) using carotid intima media thickness performed by ultrasound, in kidney transplant patients.

Detailed Description

Cardiovascular disease remains the greatest cause of mortality after kidney transplant. Traditional risk factors, such as hypertension, diabetes, hyperlipidemia and smoking, contribute to vascular disease after transplant, but nontraditional risk factors may play a bigger role in vascular disease progression in this setting. This observational study will evaluate nontraditional risk factors for their contributions to vascular disease progression as determined by carotid intima media thickness and history of vascular disease events over time. The study requires annual checks of blood, urine, history, and carotid ultrasound for carotid intima media thickness

Registry
clinicaltrials.gov
Start Date
April 2006
End Date
June 20, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Kidney transplant more than 6 months ago
  • 19 years or older

Exclusion Criteria

  • Estimated GFR \<30
  • Previous small bowel, or lung transplant
  • Pancreas transplant less than 6 months ago
  • Cancer or any condition that would change weight dramatically in the near future such as malabsorption.
  • Willing to return for testing annually for 3 years
  • Women who are pregnant

Outcomes

Primary Outcomes

Carotid Intima Media Thickness (CIMT)

Time Frame: 3 years (baseline and three year follow up)

CIMT was defined by ultrasound. The mean and standard error of a 3 year change in CIMT was assessed (between baseline and three year follow up).

Study Sites (1)

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