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Coronary Heart Disease as Measured by Coronary Calcium Score Among Individuals With Chronic Traumatic Spinal Cord Injury

Completed
Conditions
Heart Diseases
Spinal Cord Injuries
Registration Number
NCT00628446
Lead Sponsor
Wake Forest University Health Sciences
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
45
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Percent Agreement Between Coronary Calcium Score (CCS) and National Cholesterol Education Program (NCEP) GuidelinesDuring single data collection. Average duration of injury was 24.4 years +/-9.5 years

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 dividing by the total number of subjects

Secondary Outcome Measures
NameTimeMethod
Adherence to NCEP CriteriaDuring single data collection

Determine the total percentage of subjects who should be on drug therapy by NCEP criteria and who are on drug therapy who have achieved their treatment goal as defined by NCEP criteria

Trial Locations

Locations (1)

Carolinas Rehabilitation

🇺🇸

Charlotte, North Carolina, United States

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