Cardiovascular Disease Study

Spinal Cord Injury Clinical Trial

Official title:

Risk Factors for Coronary Heart Disease in Spinal Cord Injury: Conventional and Emerging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00857194
• Other study ID #: B4162C-5
• Status: Completed
• Phase: N/A
• First received: March 5, 2009
• Last updated: June 28, 2017
• Start date: March 1, 2007
• Est. completion date: June 21, 2017

Study information

• Verified date: June 2017
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: June 21, 2017
• Est. primary completion date: June 21, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	James J. Peters VA Medical Center, Bronx, NY	The Bronx	New York
United States	Kessler Institute for Rehabilitation	West Orange	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	Kessler Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	postprandial lipemic response to a high-fat meal	Blood draws following ingestion of high fat meal at 2, 4, and 6 hours to determine lipids.	baseline, 2, 4, and 6 hrs post high fat meal