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

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.

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Key information

Conditions

Spinal Cord Injuries Cardiovascular Diseases Central Nervous System Diseases Dyslipidemias Heart Diseases Lipid Metabolism Disorders Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

45 year–70 year

Sex eligibility

Male

Study type

Observational

Primary location

Carolinas Rehabilitation

Charlotte, North Carolina, 28203, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Percent Agreement Between Coronary Calcium Score (CCS) and National Cholesterol Education Program (NCEP) Guidelines

Time frame: During 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 outcomes

Adherence to NCEP Criteria

Time frame: During 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

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study 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

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2009
First posted: Mar 5, 2008
Registry last updated: Apr 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed