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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jesse Lieberman, Carolinas Healthcare System
ClinicalTrials.gov Identifier:
NCT00628446
First received: February 26, 2008
Last updated: March 30, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition
Spinal Cord Injuries
Heart Diseases

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Carolinas Healthcare System:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Adherence to NCEP Criteria [ Time Frame: During single data collection ] [ Designated as safety issue: No ]
    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


Enrollment: 45
Study Start Date: September 2007
Study Completion Date: December 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   45 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Male,Spinal Cord Injuries

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00628446

Locations
United States, North Carolina
Carolinas Rehabilitation
Charlotte, North Carolina, United States, 28203
Sponsors and Collaborators
Carolinas Healthcare System
Investigators
Principal Investigator: Jesse Lieberman, MD Carolinas Healthcare System
  More Information

Publications:

Responsible Party: Jesse Lieberman, Physician, Carolinas Healthcare System
ClinicalTrials.gov Identifier: NCT00628446     History of Changes
Other Study ID Numbers: CCS-040
Study First Received: February 26, 2008
Results First Received: February 27, 2012
Last Updated: March 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Carolinas Healthcare System:
spinal cord injury
Coronary artery calcium
Dyslipidemia

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Spinal Cord Injuries
Cardiovascular Diseases
Arteriosclerosis
 Arterial Occlusive Diseases
Vascular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on May 21, 2013