Coronary Computed Tomography (CT) to Measure Coronary Calcification in Spinal Cord Injury (SCI)
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Purpose
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.
| Condition |
|---|
|
Spinal Cord Injury |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | The Use of Non-invasive Multidetector Coronary Computed Tomography Imaging for the Assessment of Coronary Calcification in Persons With Spinal Cord Injury |
- Quantification of coronary calcium [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Determine the relationship between calcification scores and vascular reactivity [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 150 |
| Study Start Date: | February 2010 |
| Study Completion Date: | February 2012 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Group 1 |
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
SCI subjects will be included in the study if they have moderate or high risk for coronary heart disease, who have participated in a previous screening study.
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT01065896 History of Changes |
| Other Study ID Numbers: | B4162C-12 |
| Study First Received: | February 8, 2010 |
| Last Updated: | October 2, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
spinal cord injury coronary artery disease |
Additional relevant MeSH terms:
|
Calcinosis Spinal Cord Injuries Calcium Metabolism Disorders Metabolic Diseases Spinal Cord Diseases |
Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on May 23, 2013