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

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Diseases; Spinal Cord Injuries

• Study Type: Observational
• Enrollment (Actual): 45

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Carolinas Rehabilitation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Male,Spinal Cord Injuries

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Agreement Between Coronary Calcium Score (CCS) and National Cholesterol Education Program (NCEP) Guidelines	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	During single data collection. Average duration of injury was 24.4 years +/-9.5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to NCEP Criteria	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	During single data collection

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Jesse Lieberman, MD, Wake Forest University Health Sciences

Publications and helpful links

General Publications

• 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. Erratum In: J Spinal Cord Med. 2011 Jul;34(4):437.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): November 1, 2008
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: February 26, 2008
• First Submitted That Met QC Criteria: February 26, 2008
• First Posted (Estimate): March 5, 2008

Study Record Updates

• Last Update Posted (Actual): April 21, 2022
• Last Update Submitted That Met QC Criteria: April 19, 2022
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Dyslipidemia; spinal cord injury; Coronary artery calcium
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Trauma, Nervous System; Spinal Cord Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: CCS-040