An observational study in Cardiovascular Disease, Chronic Kidney Disease and Diabetes, sponsored by University of Nebraska. Completed at 1 site in United States. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2023-10-02.
Sponsored by University of Nebraska · Observational
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.
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
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 338 is above the median of 192 across 1,033 observational studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →University of Nebraska is the lead sponsor of 473 studies on the registry; 66 are open to participants now.
Of its 75 completed or terminated interventional studies of FDA-regulated products, 46 (61%) have results posted.
Counted across the registry records on this site, refreshed daily.
Transplant Clinic patients
Exclusion Criteria:
Carotid Intima Media Thickness (CIMT)
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).
Time frame: 3 years (baseline and three year follow up)
| Milestone | Kidney Transplant Recipients |
|---|---|
| Started | 338 |
| Completed | 268 |
| Not completed | 70 |
| Withdrew: Death | 23 |
| Withdrew: Withdrawal by subject | 39 |
| Withdrew: Lost to follow-up | 3 |
| Withdrew: Too much time commitment | 1 |
| Withdrew: Transfer care to other clinical site | 1 |
| Withdrew: Relocation | 3 |
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).
| millimeters (mm) | Kidney Transplant Recipients |
|---|---|
| Carotid Intima Media Thickness (CIMT) | 0.044 ± 0.006 |
Collected over 3 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Kidney Transplant Recipients | 23/338 (6.8%) | 0/338 (0%) | 0/338 (0%) |
| Age, Continuous(years) | Kidney Transplant Recipients |
|---|---|
| Mean | 52.3 ± 11.0 |
| Sex: Female, Male(Participants) | Kidney Transplant Recipients |
|---|---|
| Female | 147 |
| Male | 191 |
| Ethnicity (NIH/OMB)(Participants) | Kidney Transplant Recipients |
|---|---|
| Hispanic or Latino | 13 |
| Not Hispanic or Latino | 325 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Kidney Transplant Recipients |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 5 |
| Native Hawaiian or Other Pacific Islander | 1 |
| Black or African American | 31 |
| White | 300 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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