Cardiovascular Disease Study

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment
Spinal Cord Injury	Procedure: 2 hour Oral Glucose Tolerance Test; Procedure: Fat Meal Test

Study Design

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Observational
Actual Enrollment :	170 participants
Observational Model:	Case-Control
Time Perspective:	Prospective
Official Title:	Risk Factors for Coronary Heart Disease in Spinal Cord Injury: Conventional and Emerging
Actual Study Start Date :	March 1, 2007
Actual Primary Completion Date :	June 21, 2017
Actual Study Completion Date :	June 21, 2017

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort

Intervention/treatment

Group 2; Chronic, stable 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.

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. coronary heart disease risk factors [ Time Frame: 1 time, at time of testing ]

   Risk factors associated with coronary heart disease as follows:

   • Fasting Lipid Panel
   • Oral Glucose Tolerance Test
   • Blood Pressure
   • Body Anthropometrics
   • Family History

Secondary Outcome Measures :

1. postprandial lipemic response to a high-fat meal [ Time Frame: baseline, 2, 4, and 6 hrs post high fat meal ]
   Blood draws following ingestion of high fat meal at 2, 4, and 6 hours to determine lipids.

Biospecimen Retention:   Samples Without DNA

serum and plasma

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	45 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

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

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

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, New Jersey
Kessler Institute for Rehabilitation
West Orange, New Jersey, United States, 07052
United States, New York
James J. Peters VA Medical Center, Bronx, NY
The Bronx, New York, United States, 10468

Sponsors and Collaborators

VA Office of Research and Development

Kessler Foundation

Investigators

Principal Investigator:	William Bauman, MD	VA Office of Research and Development

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	VA Office of Research and Development
ClinicalTrials.gov Identifier:	NCT00857194 History of Changes
Other Study ID Numbers:	B4162C-5
First Posted:	March 6, 2009
Last Update Posted:	July 2, 2017
Last Verified:	June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No
Product Manufactured in and Exported from the U.S.:		No

Keywords provided by VA Office of Research and Development:

Coronary Heart Disease; spinal cord injury; risk factor; postprandial lipemia

Additional relevant MeSH terms:

Spinal Cord Injuries; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases	Trauma, Nervous System; Wounds and Injuries; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases