Cardiovascular Disease Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Department of Veterans Affairs
Sponsor:
Collaborator:
Kessler Foundation
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00857194
First received: March 5, 2009
Last updated: March 25, 2014
Last verified: March 2014

March 5, 2009
March 25, 2014
March 2007
December 2014   (final data collection date for primary outcome measure)
coronary heart disease risk factors [ Time Frame: 1 time, at time of testing ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00857194 on ClinicalTrials.gov Archive Site
postprandial lipemic response to a high-fat meal [ Time Frame: baseline, 2, 4, and 6 hrs post high fat meal ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Cardiovascular Disease Study
Risk Factors for Coronary Heart Disease in Spinal Cord Injury: Conventional and Emerging

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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

serum and plasma

Non-Probability Sample

Subjects will be recruited from hospital clinics, through advertisements, and referral from primary care physicians.

Spinal Cord Injury
  • Procedure: 2 hour Oral Glucose Tolerance Test
    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.
    Other Name: 2-hr OGTT
  • Procedure: Fat Meal Test
    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.
Group 2
Chronic, stable spinal cord injury
Interventions:
  • Procedure: 2 hour Oral Glucose Tolerance Test
  • Procedure: Fat Meal Test
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
December 2015
December 2014   (final data collection date for primary outcome measure)

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
Both
45 Years to 75 Years
Yes
Contact: Kirsten N Swonger, BS (718) 584-9000 ext 3130 kirsten.swonger@va.gov
Contact: Stephanie Pena, BS (718) 584-9000 ext 3123 stephanie.pena@va.gov
United States
 
NCT00857194
B4162C-5
No
Department of Veterans Affairs
Department of Veterans Affairs
Kessler Foundation
Principal Investigator: William Bauman, MD VA Medical Center, Bronx
Department of Veterans Affairs
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP