Clinical trial NCT00857194: Cardiovascular Disease Study
Official title: Risk Factors for Coronary Heart Disease in Spinal Cord Injury: Conventional and Emerging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Injury
Keywords: Coronary Heart Disease
spinal cord injury
risk factor
postprandial lipemia
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Kessler Foundation
First posted: 2009-03-06
Enrollment: 170
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be recruited from hospital clinics, through advertisements, and referral from primary care physicians.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Male 45-75 years old with at least 5 years of SCI
* Female 45-50 years old with at least 10 years of SCI
* Female 50-75 years old with at least 5 years of SCI

Exclusion Criteria:

* Acute medical illness
* Pregnant females
* Chronic debilitating disease (i.e., heart disease, pulmonary disease, etc.)
* Atrial fibrillation
* History of percutaneous coronary angiography with stent placement

Primary outcomes:
measure: coronary heart disease risk factors
timeFrame: 1 time, at time of testing
Secondary outcomes:
measure: postprandial lipemic response to a high-fat meal
timeFrame: baseline, 2, 4, and 6 hrs post high fat meal
Other outcomes:
Locations:
city: West Orange
country: United States
facility: Kessler Institute for Rehabilitation
state: New Jersey
city: The Bronx
country: United States
facility: James J. Peters VA Medical Center, Bronx, NY
state: New York
Study officials:
affiliation: James J. Peters Veterans Affairs Medical Center
name: William Bauman, MD
role: PRINCIPAL_INVESTIGATOR
References: