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

Heart Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00628446
• Other study ID #: CCS-040
• Status: Completed
• Start date: September 2007
• Est. completion date: December 2009

Study information

• Verified date: July 2015
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 2009
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Myocardial Ischemia
• Spinal Cord Injuries
• Wounds and Injuries

Locations

Country	Name	City	State
United States	Carolinas Rehabilitation	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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 paradi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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