N/A
N=45
Coronary Heart Disease as Measured by Coronary Calcium Score Among Individuals With Chronic Traumatic Spinal Cord Injury
Spinal Cord Injuries · Heart Diseases
Bottom Line
View on ClinicalTrials.gov: NCT00628446 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
May 2013
Primary outcome: Primary: Percent Agreement Between Coronary Calcium Score (CCS) and National Cholesterol Education Program (NCEP) Guidelines — 18 percent agreement
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- Male
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Nov 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Agreement Between Coronary Calcium Score (CCS) and National Cholesterol Education Program (NCEP) Guidelines |
18 | — |
| SECONDARY Adherence to NCEP Criteria |
39.5 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Male
- Spinal Cord Injury due to externally inflicted trauma
- > or = 10 years post injury
- American Spinal Injury Association (ASIA) Scale A,B, or C
- 45 to 70 years of age
- Communication and comprehension sufficient for compliance with all testing procedures
- Voluntary informed consent
Exclusion Criteria
- Spinal Cord Injury of non-traumatic etiology
- Injury < 10 years prior to enrollment
- Known Coronary Heart Disease
Data sourced from ClinicalTrials.gov (NCT00628446). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.