Vascular Risk After Kidney Transplantation
| Tracking Information | |||||
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| First Received Date ICMJE | September 8, 2006 | ||||
| Last Updated Date | June 18, 2012 | ||||
| Start Date ICMJE | April 2006 | ||||
| Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00374595 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Vascular Risk After Kidney Transplantation | ||||
| Official Title ICMJE | Vascular Risk After Kidney Transplantation | ||||
| 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. |
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| 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 |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Time Perspective: Prospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Transplant Clinic patients |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 342 | ||||
| Completion Date | June 2012 | ||||
| Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 19 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00374595 | ||||
| Other Study ID Numbers ICMJE | 053-95-FB, 1 RO1 DK069919-01A2 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Jennifer Larsen, MD, University of Nebraska | ||||
| Study Sponsor ICMJE | University of Nebraska | ||||
| Collaborators ICMJE | National Institutes of Health (NIH) | ||||
| Investigators ICMJE |
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| Information Provided By | University of Nebraska | ||||
| Verification Date | June 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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