Cardiovascular Disease Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 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: August 27, 2014
Last verified: August 2014
  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 Department of Veterans Affairs:

Primary Outcome Measures:
  • coronary heart disease risk factors [ Time Frame: 1 time, at time of testing ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples Without DNA

serum and plasma


Estimated Enrollment: 200
Study Start Date: March 2007
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (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

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00857194

Contacts
Contact: Joshua C Hobson, MS (718) 584-9000 ext 3129 joshua.hobson@va.gov
Contact: Stephanie A Pena, BS (718) 584-9000 ext 3123 stephanie.pena@va.gov

Locations
United States, New Jersey
Kessler Institute for Rehabilitation Recruiting
West Orange, New Jersey, United States, 07052
Contact: Christopher M Cirnigliaro, MS    973-243-6892 ext 2755      
United States, New York
VA Medical Center, Bronx Recruiting
Bronx, New York, United States, 10468
Contact: Joshua C Hobson, MS    718-584-9000 ext 3129    joshua.hobson@va.gov   
Contact: Stephanie A Pena, BS    (718) 584-9000 ext 3123    stephanie.pena@va.gov   
Principal Investigator: William Bauman, MD         
Sponsors and Collaborators
Kessler Foundation
Investigators
Principal Investigator: William Bauman, MD VA Medical Center, Bronx
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00857194     History of Changes
Other Study ID Numbers: B4162C-5
Study First Received: March 5, 2009
Last Updated: August 27, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Coronary Heart Disease
spinal cord injury
risk factor
postprandial lipemia
Healthy Able-bodied Controls

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Artery Disease
Coronary Disease
Arterial Occlusive Diseases
Central Nervous System Diseases
Heart Diseases
Nervous System Diseases
Spinal Cord Diseases
Vascular Diseases
Myocardial Ischemia
Spinal Cord Injuries
Arteriosclerosis
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on October 20, 2014