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Coronary Heart Disease as Measured by Coronary Calcium Score Among Individuals With Chronic Traumatic Spinal Cord Injury
This study is currently recruiting participants.
Verified by Carolinas Healthcare System, February 2008
Sponsored by: Carolinas Healthcare System
Information provided by: Carolinas Healthcare System
ClinicalTrials.gov Identifier: NCT00628446
  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

MedlinePlus related topics: Calcium Coronary Artery Disease Heart Diseases Spinal Cord Injuries
Drug Information available for: Calcium gluconate
U.S. FDA Resources
Study Type: Observational
Study Design: Case Control, Prospective
Official Title: Prevalence and Risk of Coronary Heart Disease as Measured by Coronary Calcium Score Among Individuals With Chronic Traumatic Spinal Cord Injury: A Pilot Study

Further study details as provided by Carolinas Healthcare System:

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 40
Study Start Date: September 2007
Estimated Study Completion Date: June 2008
Estimated Primary Completion Date: May 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
  • 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

Contacts
Contact: Marybeth P Whitney, BSN 704.355.1409 marybeth.whitney@carolinashealthcare.org
Contact: Jesse Lieberman, MD 704.355.1409 jesse.lieberman@carolinashealthcare.org

Locations
United States, North Carolina
Carolinas Rehabilitation Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Marybeth P Whitney, BSN     704-355-1409     marybeth.whitney@carolinashealthcare.org    
Principal Investigator: Jesse Lieberman, MD            
Sponsors and Collaborators
Carolinas Healthcare System
Investigators
Principal Investigator: Jesse Lieberman, MD Carolinas Healthcare System
  More Information

Responsible Party: Carolinas HealthCare System ( Jesse Lieberman, MD )
Study ID Numbers: CCS-040
Study First Received: February 26, 2008
Last Updated: October 23, 2008
ClinicalTrials.gov Identifier: NCT00628446  
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Arterial Occlusive Diseases
Heart Diseases
Spinal Cord Diseases
Myocardial Ischemia
Vascular Diseases
Wounds and Injuries
Disorders of Environmental Origin
Central Nervous System Diseases
Ischemia
Arteriosclerosis
Trauma, Nervous System
Coronary Disease
Calcium, Dietary
Spinal Cord Injuries
Coronary Artery Disease

Additional relevant MeSH terms:
Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009