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Risk Factors for Coronary Heart Disease in Spinal Cord Injury: Conventional and Emerging
Sponsor study identifier
observational
170
1 country
2
Study Start
March 1, 2007
Actual (reported)Primary Completion
June 21, 2017
Actual (reported)Study Completion
June 21, 2017
Actual (reported)Coronary heart disease (CHD) is a leading cause of death in the spinal cord injured (SCI) population, occurring at younger ages than in the able-bodied population. Conventional risk factors for CHD include high concentrations of low-density lipoprotein (LDL), low concentrations of high-density lipoprotein (HDL), diabetes mellitus (DM), smoking history, and family history. Other factors that may influence progression of CHD include C-reactive protein (an inflammatory marker), and fibrinogen (a pro-coagulant marker). Individuals with SCI with longer duration and greater completeness of injury are more likely to have significantly worse carbohydrate tolerance compared to other neurological deficit subgroups. Muscle atrophy after SCI is associated with increased insulin resistance. Prolonged inactivity has been shown to be associated with hyperinsulinemia and impaired glucose tolerance. Body composition changes after SCI to indicate significantly more total body fat mass and percent fat and less lean mass compared to able-bodied individuals. Carotid intima-media thickness is correlated with atherosclerosis progression and abdominal adiposity. Individuals with abdominal adiposity are at a higher risk for CHD, DM, hypertension, insulin resistance, and dyslipidemia. Abdominal adiposity and insulin resistance are contributors to postprandial lipemia, which may be a more sensitive indicator of CHD risk and progression. The purpose of this study is to determine the prevalence of conventional risk factors by assessing the 10-year risk for CHD, and identify emerging risk factors for CHD in the spinal cord injured population. Subjects will have the option to participate in a high fat meal test to determine postprandial lipemic responses. Knowledge of this information may be able to detect and prevent future cardiovascular events related to CHD.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 21, 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 1, 2007
Actual (reported)March 5, 2009
Actual (reported)March 6, 2009
Actual (reported)June 21, 2017
Actual (reported)June 21, 2017
Actual (reported)coronary heart disease risk factors
Risk factors associated with coronary heart disease as follows: * Fasting Lipid Panel * Oral Glucose Tolerance Test * Blood Pressure * Body Anthropometrics * Family History
1 time, at time of testing
postprandial lipemic response to a high-fat meal
baseline, 2, 4, and 6 hrs post high fat meal
Chronic, stable spinal cord injury
Fasting baseline blood samples will be drawn for analysis of insulin and glucose. A 75-gram glucose solution will be administered and subjects remain sedentary for 2 hours. After 2 hours, blood is drawn to analyze post-load insulin and glucose levels.
A fasting blood draw is performed for analysis of lipids, insulin, and glucose. Subjects ingest a high fat meal (milkshake made from heavy whipping cream and premium ice cream) within 15 minutes. Postprandial blood draws at 2, 4, and 6 hours are made for analysis of lipids, insulin, and glucose.
Subjects will be recruited from hospital clinics, through advertisements, and referral from primary care physicians.
Kessler Institute for Rehabilitation
West Orange, New Jersey, 07052, United States
James J. Peters VA Medical Center, Bronx, NY
The Bronx, New York, 10468, United States
serum and plasma
William Bauman, MD
James J. Peters Veterans Affairs Medical Center
170 participants (actual enrollment reported by the registry).
First Submitted
March 5, 2009
First Posted
March 6, 2009
Study Start
March 1, 2007
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
June 21, 2017
Actual (reported)Study Completion
June 21, 2017
Actual (reported)Last Updated
July 2, 2017
Record last verified: 2017-06
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Source: ClinicalTrials.gov.
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