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Coronary Artery Calcification Score and Risk Factors for Coronary Artery Disease in Persons With Spinal Cord Injury (CAC)
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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 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 |
|---|
| Spinal Cord Injury |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Coronary Artery Calcification (CAC) Score and Risk Factors for Coronary Artery Disease in Persons With Spinal Cord Injury(SCI) |
- 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
| Estimated Enrollment: | 100 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | December 2022 |
| Estimated Primary Completion Date: | December 2021 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Spinal Cord Injury
Chronic SCI (Duration of Injury >5 years)
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 35 Years to 75 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Inclusion Criteria:
- Males 40-75 years old with at least 5 yrs of SCI; males 35-40 years old with at least 10 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.
Exclusion Criteria:
- 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.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT02007226
| Contact: Kirsten N Swonger, BS | 718-584-9000 ext 5426 | kirsten.swonger@va.gov | |
| Contact: Pierre K Asselin, MS | 718-584-9000 ext 3124 | pierre.asselin@va.gov |
| United States, New Jersey | |
| Kessler Institute for Rehabilitation | Active, not recruiting |
| West Orange, New Jersey, United States, 07052 | |
| United States, New York | |
| James J Peters VA Medical Center | Recruiting |
| Bronx, New York, United States, 10468 | |
| Contact: Md. Samiul J Sarker, MD 718-584-9000 ext 3126 md.sarker@va.gov | |
| Principal Investigator: William A Bauman, MD | |
| Principal Investigator: | William A Bauman, MD | James J. Peters Veterans Affairs Medical Center |
More Information
Publications:
| Responsible Party: | William A. Bauman, M.D., Director: SCI Research Center, James J. Peters Veterans Affairs Medical Center |
| ClinicalTrials.gov Identifier: | NCT02007226 History of Changes |
| Other Study ID Numbers: |
BAU-11-075 |
| Study First Received: | December 14, 2012 |
| Last Updated: | February 28, 2017 |
Keywords provided by William A. Bauman, M.D., James J. Peters Veterans Affairs Medical Center:
|
Coronary Heart Disease spinal cord injury risk factor postprandial lipemia |
Additional relevant MeSH terms:
|
Coronary Artery Disease Coronary Disease Heart Diseases Wounds and Injuries Myocardial Ischemia Spinal Cord Injuries Calcinosis Cardiovascular Diseases Arteriosclerosis |
Arterial Occlusive Diseases Vascular Diseases Spinal Cord Diseases Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System Calcium Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on June 28, 2017