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

NCT02007226 | Completed

• 1 other identifier: BAU-11-075
• Study Type: observational
• Target: 83
• Locations: 1 country
• Sites: 2

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.

Conditions

Spinal Cord Injury

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Coronary heart disease risk factors

  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.

  Testing will be performed at day 1 for all parameters

Secondary Outcomes (1)

• Postprandial lipemic response to a high fat meal(1.3 gm/kg body weight)

  Single fat meal challenge test will be performed at day 1.

Study Arms (1)

Spinal Cord Injury

Chronic SCI (Duration of Injury \>5 years)

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• James J. Peters Veterans Affairs Medical Center: lead

Study Sites (2)

Kessler Institute for Rehabilitation

West Orange, New Jersey, 07052, United States

Location

James J Peters VA Medical Center

The Bronx, New York, 10468, United States

Location

Related Publications (6)

• 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. doi: 10.1080/07315724.2010.10719884.

  PMID: 21504974 BACKGROUND

• Bauman WA, Spungen AM. Carbohydrate and lipid metabolism in chronic spinal cord injury. J Spinal Cord Med. 2001 Winter;24(4):266-77. doi: 10.1080/10790268.2001.11753584.

  PMID: 11944785 BACKGROUND

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

  PMID: 10680161 BACKGROUND

• 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. doi: 10.1016/0026-0495(94)90126-0.

  PMID: 8201966 BACKGROUND

• 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.

  PMID: 1574072 BACKGROUND

• McCauley LS, Ghatas MP, Sumrell RM, Cirnigliaro CM, Kirshblum SC, Bauman WA, Gorgey AS. Measurement of Visceral Adipose Tissue in Persons With Spinal Cord Injury by Magnetic Resonance Imaging and Dual X-Ray Absorptiometry: Generation and Application of a Predictive Equation. J Clin Densitom. 2020 Jan-Mar;23(1):63-72. doi: 10.1016/j.jocd.2018.12.003. Epub 2018 Dec 15.

  PMID: 30638769 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Serum and Plasma

MeSH Terms

Conditions

Spinal Cord Injuries; Coronary Disease

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• William A Bauman, MD

  James J. Peters Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director: SCI Research Center

Study Record Dates

• First Submitted: December 14, 2012
• First Posted: December 10, 2013
• Study Start: October 1, 2013
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: April 20, 2022

Record last verified: 2022-04

Locations

US (2)