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NCT00628446 · ClinicalTrials.gov registry record
Coronary Heart Disease as Measured by Coronary Calcium Score Among Individuals With Chronic Traumatic Spinal Cord Injury
A clinical trial, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- 45
- Enrollment target
NCT00628446: Completed study, sponsored by Wake Forest University Health Sciences.
NCT00628446 is a clinical trial that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 45 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00628446 has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- 45 participants
- Enrollment target
Study Summary
This study includes male subjects age 45 to 70, who have sustained a traumatic Spinal Cord Injury (SCI) at least 10 years prior. Subjects will be interviewed for demographic data, including heart disease risk factors. A blood test for cholesterol levels will be drawn. A CT scan of arteries of the heart will be performed to determine the presence of coronary calcium, a marker of subclinical Coronary Heart Disease. Scoring of Coronary Calcium or Coronary Calcium Score (CCS) is automated by the CT scanner. Each subject's Framingham Risk Score will be calculated; This is an individuals 10 year risk of having a Coronary Heart Disease event (significant symptoms). In addition, it will be determined if subjects are being treated for diagnosed dyslipidemia (high cholesterol) according to the National Cholesterol Educational Program (NCEP) guidelines. The proposed pilot study aims to better understand the problem of Coronary Heart Disease in individuals with Spinal Cord Injury, specifically CCS in SCI, when compared to the general population.
Primary Outcome
Participants were classified as high risk, intermediate high risk, intermediate low risk, and low risk based upon both their CCS and their LDL using NCEP Adult Treatment Panel III Guidelines. Those with CCS \>/-400 were considered high risk, CCS=100-399 were intermediate high risk, CCS=1-99 intermediate low risk, and CCS=0 were low risk. The percent agreement between CCS and NCEP Guidelines was calculated by totaling the number of subjects who were classified in the same risk category and dividi
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2007-09 |
| Est. Completion | 2009-12 |
What the finished NCT00628446 record still lists
NCT00628446 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 45 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT00628446 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00628446 about?
NCT00628446 is a clinical study titled "Coronary Heart Disease as Measured by Coronary Calcium Score Among Individuals With Chronic Traumatic Spinal Cord Injury". This study includes male subjects age 45 to 70, who have sustained a traumatic Spinal Cord Injury (SCI) at least 10 years prior. Subjects will be interviewed for demographic data, including heart disease risk factors. A blood test for cholesterol levels will be drawn. A CT scan of arteries of the he...
What is the current status of trial NCT00628446?
This trial is currently completed. The enrollment target is 45 participants. The study started on 2007-09. Estimated completion is 2009-12.
Who is sponsoring clinical trial NCT00628446?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
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