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

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ClinicalTrials.gov Identifier: NCT00628446
Recruitment Status : Completed
First Posted : March 5, 2008
Results First Posted : May 16, 2013
Last Update Posted : August 14, 2015
Sponsor:
Information provided by (Responsible Party):
Jesse Lieberman, Carolinas Healthcare System

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.


Condition or disease
Spinal Cord Injuries Heart Diseases

Study Type : Observational
Actual Enrollment : 45 participants
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
Study Start Date : September 2007
Actual Primary Completion Date : November 2008
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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



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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications of Results:
Responsible Party: Jesse Lieberman, Physician, Carolinas Healthcare System
ClinicalTrials.gov Identifier: NCT00628446     History of Changes
Other Study ID Numbers: CCS-040
First Posted: March 5, 2008    Key Record Dates
Results First Posted: May 16, 2013
Last Update Posted: August 14, 2015
Last Verified: July 2015

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

Additional relevant MeSH terms:
Wounds and Injuries
Heart Diseases
Spinal Cord Injuries
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs