Coronary Artery Calcification Score and Risk Factors for Coronary Artery Disease in Persons With Spinal Cord Injury (CAC)
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|ClinicalTrials.gov Identifier: NCT02007226|
Recruitment Status : Completed
First Posted : December 10, 2013
Last Update Posted : April 20, 2022
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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.
|Condition or disease|
|Spinal Cord Injury|
|Study Type :||Observational|
|Actual Enrollment :||83 participants|
|Official Title:||Coronary Artery Calcification (CAC) Score and Risk Factors for Coronary Artery Disease in Persons With Spinal Cord Injury(SCI)|
|Actual Study Start Date :||October 2013|
|Actual Primary Completion Date :||April 2020|
|Actual Study Completion Date :||April 2020|
Spinal Cord Injury
Chronic SCI (Duration of Injury >5 years)
- Coronary heart disease risk factors [ Time Frame: Testing will be performed at day 1 for all parameters ]The relationship of coronary artery calcification (CAC) with conventional risk factors (cigarette smoking, hypertension, low high density lipoprotein(HDL) cholesterol, diabetes) and nonconventional risk factors (abdominal fat, inflammatory biomarkers, arterial stiffness, intima media thickness of carotid artery) is being tested to determine the prevalence and severity of coronary artery calcification (CAC) score of SCI individuals with age, gender and ethnically matched controls.
- Postprandial lipemic response to a high fat meal(1.3 gm/kg body weight) [ Time Frame: Single fat meal challenge test will be performed at day 1. ]To determine the postprandial lipemic response to fat load in persons with SCI and to correlate these parameters to other risk factors for CAD and CAC score.
Biospecimen Retention: Samples With DNA
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|Ages Eligible for Study:||45 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Probability Sample|
- 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.
- Acute medical illness;
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02007226
|United States, New Jersey|
|Kessler Institute for Rehabilitation|
|West Orange, New Jersey, United States, 07052|
|United States, New York|
|James J Peters VA Medical Center|
|Bronx, New York, United States, 10468|
|Principal Investigator:||William A Bauman, MD||James J. Peters Veterans Affairs Medical Center|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||William A. Bauman, M.D., Director: SCI Research Center, James J. Peters Veterans Affairs Medical Center|
|Other Study ID Numbers:||
|First Posted:||December 10, 2013 Key Record Dates|
|Last Update Posted:||April 20, 2022|
|Last Verified:||April 2022|
Coronary Heart Disease
spinal cord injury
Spinal Cord Injuries
Coronary Artery Disease
Wounds and Injuries
Arterial Occlusive Diseases
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System