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

NCT ID: NCT00628446

Last Updated: 2022-04-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 45 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2009-12-31

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.

Conditions

Spinal Cord Injuries; Heart Diseases

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jesse Lieberman, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Carolinas Rehabilitation

Charlotte, North Carolina, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 21675362 (View on PubMed)

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.

Reference Type: RESULT

PMID: 21528624 (View on PubMed)

Other Identifiers

CCS-040

Identifier Type: -

Identifier Source: org_study_id