Coronary Artery Calcification Score and Risk Factors for Coronary Artery Disease in Persons With Spinal Cord Injury (CAC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by James J. Peters Veterans Affairs Medical Center
Sponsor:
Information provided by (Responsible Party):
William A. Bauman, M.D., James J. Peters Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT02007226
First received: December 14, 2012
Last updated: December 5, 2013
Last verified: December 2013
  Purpose

Although conventional risk factors for coronary heart disease (CHD) have been identified and routinely used to determine risk for CHD in the general population, a systematic approach to determine population-specific risk for CHD has not been performed prospectively in those with SCI. CHD is a leading cause of death in spinal cord injury, occurring at younger ages than in the able-bodied population. Conventional risk factors for CHD are high serum concentrations of low-density lipoprotein (LDL), low serum concentrations of high-density lipoprotein (HDL), diabetes mellitus (DM), positive smoking history, and positive family history of premature CHD.

Coronary Artery calcification (CAC) is a commonly occurring phenomenon that does not necessarily indicate significant obstructive disease. Studies have shown that a strong association exists between coronary calcification and coronary heart disease. The purpose of this study is to compare the CAC scores in persons with SCI with a historical control group of able-bodied persons from a national data base who will be matched for conventional risk factors for coronary artery disease (CAD) and to determine the relationship between CAC scores and conventional and emerging risk factors for CAD. Additionally, postprandial lipemic (elevated levels of lipids following ingestion of food) responses among individuals with SCI and control subjects will be compared, as well as the response of inflammatory markers following a high fat meal. Participants will only be tested once for these parameters.


Condition
Spinal Cord Injury

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Coronary Artery Calcification (CAC) Score and Risk Factors for Coronary Artery Disease in Persons With Spinal Cord Injury(SCI)

Resource links provided by NLM:


Further study details as provided by James J. Peters Veterans Affairs Medical Center:

Primary Outcome Measures:
  • Coronary heart disease risk factors [ Time Frame: Testing will be performed at day 1 for all parameters ] [ Designated as safety issue: No ]
    The relationship of coronary artery calcification (CAC) with conventional risk factors (cigarette smoking, hypertension, low high density lipoprotein(HDL) cholesterol, diabetes) and nonconventional risk factors (abdominal fat, inflammatory biomarkers, arterial stiffness, intima media thickness of carotid artery) is being tested to determine the prevalence and severity of coronary artery calcification (CAC) score of SCI individuals with age, gender and ethnically matched controls.


Secondary Outcome Measures:
  • Postprandial lipemic response to a high fat meal(1.3 gm/kg body weight) [ Time Frame: Single fat meal challenge test will be performed at day 1. ] [ Designated as safety issue: No ]
    To determine the postprandial lipemic response to fat load in persons with SCI and to correlate these parameters to other risk factors for CAD and CAC score.


Biospecimen Retention:   Samples With DNA

Serum and Plasma


Estimated Enrollment: 100
Study Start Date: February 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Spinal Cord Injury
Chronic SCI (Duration of Injury >5 years)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • Males 40-75 years old with at least 5 yrs of SCI; males 35-40 years old with at least 10 yrs of SCI;
  • Females 50-75 years old with at least 5 yrs of SCI; females 40-50 years old with at least 10 yrs of SCI;
  • Stable SCI (regardless of level of lesion or completeness of injury).
  • Ability to sign consent form.

For Optional Fat Meal Test Only

  • Must have completed initial risk factor assessment as previously described.

Exclusion Criteria:

  • Acute medical illness;
  • Pregnancy;
  • Chronic debilitating disease (i.e., severe pulmonary disease, stage IV pressure ulcers, etc.);
  • Atrial fibrillation;
  • History of percutaneous coronary angiography with stent placement.

For Optional Fat Meal Test Only:

  • Known diabetes;
  • Lactose-intolerance or dairy allergy;
  • Allergy to chocolate.
  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: NCT02007226

Contacts
Contact: Kirsten N Swonger, BS 718-584-9000 ext 5426 kirsten.swonger@va.gov
Contact: Pierre K Asselin, MS 718-584-9000 ext 3124 pierre.asselin@va.gov

Locations
United States, New Jersey
Kessler Institute for Rehabilitation Active, not recruiting
West Orange, New Jersey, United States, 07052
United States, New York
James J Peters VA Medical Center Recruiting
Bronx, New York, United States, 10468
Contact: Md. Samiul J Sarker, MD    718-584-9000 ext 3126    md.sarker@va.gov   
Principal Investigator: William A Bauman, MD         
Sponsors and Collaborators
James J. Peters Veterans Affairs Medical Center
Investigators
Principal Investigator: William A Bauman, MD James J. Peters Veterans Affairs Medical Center
  More Information

Publications:
Responsible Party: William A. Bauman, M.D., Director: SCI Research Center, James J. Peters Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT02007226     History of Changes
Other Study ID Numbers: BAU-11-075
Study First Received: December 14, 2012
Last Updated: December 5, 2013
Health Authority: United States: Federal Government

Keywords provided by James J. Peters Veterans Affairs Medical Center:
Coronary Heart Disease
spinal cord injury
risk factor
postprandial lipemia

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

ClinicalTrials.gov processed this record on September 18, 2014