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Cardiovascular Disease Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00857194
First Posted: March 6, 2009
Last Update Posted: July 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Kessler Foundation
Information provided by (Responsible Party):
VA Office of Research and Development
  Purpose

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 Intervention
Spinal Cord Injury Procedure: 2 hour Oral Glucose Tolerance Test Procedure: Fat Meal Test

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Risk Factors for Coronary Heart Disease in Spinal Cord Injury: Conventional and Emerging

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • 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:
  • 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

Enrollment: 170
Actual Study Start Date: March 1, 2007
Study Completion Date: June 21, 2017
Primary Completion Date: June 21, 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00857194


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

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00857194     History of Changes
Other Study ID Numbers: B4162C-5
First Submitted: March 5, 2009
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