Coronary Artery Calcification Score and Risk Factors for Coronary Artery Disease in Persons With Spinal Cord Injury (CAC)
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02007226|
Recruitment Status : Recruiting
First Posted : December 10, 2013
Last Update Posted : September 1, 2017
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|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|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|
Spinal Cord Injury
Chronic SCI (Duration of Injury >5 years)
- 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.
- 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
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): NCT02007226
|Contact: Joshua C Hobson, MS||718-584-9000 ext email@example.com|
|Contact: Pierre K Asselin, MS||718-584-9000 ext firstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator: William A Bauman, MD|
|Principal Investigator:||William A Bauman, MD||James J. Peters Veterans Affairs Medical Center|