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Clinical Trials/NCT01065896
NCT01065896
Completed
Not Applicable

The Use of Non-invasive Multidetector Coronary Computed Tomography Imaging for the Assessment of Coronary Calcification in Persons With Spinal Cord Injury

US Department of Veterans Affairs1 site in 1 country150 target enrollmentFebruary 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Spinal Cord Injury
Sponsor
US Department of Veterans Affairs
Enrollment
150
Locations
1
Primary Endpoint
Quantification of coronary calcium
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

Although conventional risk factors for coronary heart disease (CHD) have been identified and routinely used to determine risk for CHD in the general population, a systematic approach to determine population-specific risk for CHD has not been performed prospectively in those with SCI. CHD is a leading cause of death in spinal cord injury, occurring at younger ages than in the able-bodied population. Conventional risk factors for CHD are high serum concentrations of low-density lipoprotein (LDL), low serum concentrations of high-density lipoprotein (HDL), diabetes mellitus (DM), positive smoking history, and positive family history of premature CHD.

Coronary calcification (CAC) is a commonly occurring phenomenon that does not necessarily indicate significant obstructive disease. Studies have shown that a strong association exists between coronary calcification and coronary heart disease. The purpose of this study is to compare the CAC scores in persons with SCI with a historical control group of able-bodied persons from a national data base who will be matched for conventional risk factors for coronary artery disease (CAD) and to determine the relationship between CAC scores and conventional and emerging risk factors for CAD.

Registry
clinicaltrials.gov
Start Date
February 2010
End Date
February 2012
Last Updated
13 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Male or female, 18 to 70 years of age;
  • Chronic (e.g., duration of injury at least 6 months), stable SCI (regardless of level of lesion or completeness of injury);
  • Concurrently participating in or previously completed protocol # 0454-06-073, "Risk Factors for Coronary Heart Disease in Spinal Cord Injury: conventional and emerging".

Exclusion Criteria

  • Acute medical illness;
  • Pregnancy (as determined by a pregnancy test \< 1 week of the study); and
  • The presence of a chronic disease (i.e., heart disease, pulmonary disease, etc.);
  • Inability to comply with breathing instructions.

Outcomes

Primary Outcomes

Quantification of coronary calcium

Time Frame: 2 years

Secondary Outcomes

  • Determine the relationship between calcification scores and vascular reactivity(2 years)

Study Sites (1)

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