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

Study Description

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

Brief Summary:

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 or disease
Spinal Cord Injury

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Study Design

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Study Type :	Observational
Estimated Enrollment :	100 participants
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)
Study Start Date :	February 2012
Estimated Primary Completion Date :	December 2021
Estimated Study Completion Date :	December 2022

Groups and Cohorts

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Group/Cohort
Spinal Cord Injury; Chronic SCI (Duration of Injury >5 years)

Outcome Measures

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Primary Outcome Measures :

1. Coronary heart disease risk factors [ Time Frame: Testing will be performed at day 1 for all parameters ]
   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 :

1. 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. ]
   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

Eligibility Criteria

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Ages Eligible for Study:	45 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
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 45-75 years old with at least 5 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

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

Contacts

Contact: Joshua C Hobson, MS	718-584-9000 ext 3129	joshua.hobson@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	Recruiting
West Orange, New Jersey, United States, 07052
Contact: Christopher M Cirnigliaro, MS 973-243-6892 ext 2755
United States, New York
James J Peters VA Medical Center	Recruiting
The Bronx, New York, United States, 10468
Contact: Joshua C Hobson, MS 718-584-9000 ext 3129 joshua.hobson@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

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

Publications:

Emmons RR, Garber CE, Cirnigliaro CM, Moyer JM, Kirshblum SC, Galea MD, Spungen AM, Bauman WA. The influence of visceral fat on the postprandial lipemic response in men with paraplegia. J Am Coll Nutr. 2010 Oct;29(5):476-81.

Bauman WA, Spungen AM. Carbohydrate and lipid metabolism in chronic spinal cord injury. J Spinal Cord Med. 2001 Winter;24(4):266-77. Review.

Bauman WA, Spungen AM. Metabolic changes in persons after spinal cord injury. Phys Med Rehabil Clin N Am. 2000 Feb;11(1):109-40. Review.

Bauman WA, Spungen AM. Disorders of carbohydrate and lipid metabolism in veterans with paraplegia or quadriplegia: a model of premature aging. Metabolism. 1994 Jun;43(6):749-56.

Bauman WA, Spungen AM, Raza M, Rothstein J, Zhang RL, Zhong YG, Tsuruta M, Shahidi R, Pierson RN Jr, Wang J, et al. Coronary artery disease: metabolic risk factors and latent disease in individuals with paraplegia. Mt Sinai J Med. 1992 Mar;59(2):163-8.

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
First Posted:	December 10, 2013
Last Update Posted:	September 1, 2017
Last Verified:	August 2017

Keywords provided by William A. Bauman, M.D., James J. Peters Veterans Affairs Medical Center:

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

Additional relevant MeSH terms:

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