Clinical trial NCT00628446: Coronary Heart Disease as Measured by Coronary Calcium Score Among Individuals With Chronic Traumatic Spinal Cord Injury
Official title: Prevalence and Risk of Coronary Heart Disease as Measured by Coronary Calcium Score Among Individuals With Chronic Traumatic Spinal Cord Injury(SCI): A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Injuries
Heart Diseases
Keywords: spinal cord injury
Coronary artery calcium
Dyslipidemia
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2008-03-05
Enrollment: 45
Sex: MALE
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male,Spinal Cord Injuries

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.


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

Primary outcomes:
measure: Percent Agreement Between Coronary Calcium Score (CCS) and National Cholesterol Education Program (NCEP) Guidelines
timeFrame: During single data collection. Average duration of injury was 24.4 years +/-9.5 years
Secondary outcomes:
measure: Adherence to NCEP Criteria
timeFrame: During single data collection
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Carolinas Rehabilitation
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Jesse Lieberman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lieberman JA, Hammond FM, Barringer TA, Norton HJ, Goff DC Jr, Bockenek WL, Scelza WM. Comparison of coronary artery calcification scores and National Cholesterol Education program guidelines for coronary heart disease risk assessment and treatment paradigms in individuals with chronic traumatic spinal cord injury. J Spinal Cord Med. 2011;34(2):233-40. doi: 10.1179/107902610X12923394765733.
citation: Lieberman JA, Hammond FM, Barringer TA, Goff DC Jr, Norton HJ, Bockenek WL, Scelza WM. Adherence with the National Cholesterol Education Program guidelines in men with chronic spinal cord injury. J Spinal Cord Med. 2011;34(1):28-34. doi: 10.1179/107902610x12883422813589.