Coronary Artery Calcification Score and Risk Factors for Coronary Artery Disease in Persons With Spinal Cord Injury
Completed
Conditions studied: Spinal Cord Injury
In brief
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 Artery 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. Additionally, postprandial lipemic (elevated levels of lipids following ingestion of food) responses among individuals with SCI and control subjects will be compared, as well as the response of inflammatory markers following a high fat meal. Participants will only be tested once for these parameters.
Key facts
- Study ID
- NCT02007226
- Run by
- James J. Peters Veterans Affairs Medical Center
- People needed
- 83
- Starts
- 2013-10-01
- Expected to finish
- 2020-04-01
- Last updated by the study team
- 2022-04-20
Who can join
Age: 45 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Males 45-75 years old with at least 5 yrs of SCI
- Females 50-75 years old with at least 5 yrs of SCI; females 40-50 years old with at least 10 yrs of SCI;
- Stable SCI (regardless of level of lesion or completeness of injury).
- Ability to sign consent form.
- For Optional Fat Meal Test Only
- Must have completed initial risk factor assessment as previously described.
You may not qualify if…
- Acute medical illness;
- Pregnancy;
- Chronic debilitating disease (i.e., severe pulmonary disease, stage IV pressure ulcers, etc.);
- Atrial fibrillation;
- History of percutaneous coronary angiography with stent placement.
- For Optional Fat Meal Test Only:
- Known diabetes;
- Lactose-intolerance or dairy allergy;
- Allergy to chocolate.
Where it is running
- Kessler Institute for Rehabilitation — West Orange, New Jersey, United States
- James J Peters VA Medical Center — The Bronx, New York, United States
Full record on ClinicalTrials.gov
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