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OpenTrials
Completed

NCT Number: NCT01065896

Coronary Computed Tomography (CT) to Measure Coronary Calcification in Spinal Cord Injury (SCI)

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.

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Key information

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  1. Quantification of coronary calcium

    Time frame: 2 years

Secondary outcomes

  1. Determine the relationship between calcification scores and vascular reactivity

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

US Department of Veterans Affairs

Fed

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Feb 9, 2010
Registry last updated
Oct 3, 2012

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.

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