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This study includes male subjects age 45 to 70, who have sustained a traumatic Spinal Cord Injury (SCI) at least 10 years prior. Subjects will be interviewed for demographic data, including heart disease risk factors. A blood test for cholesterol levels will be drawn. A CT scan of arteries of the heart will be performed to determine the presence of coronary calcium, a marker of subclinical Coronary Heart Disease. Scoring of Coronary Calcium or Coronary Calcium Score (CCS) is automated by the CT scanner. Each subject's Framingham Risk Score will be calculated; This is an individuals 10 year risk of having a Coronary Heart Disease event (significant symptoms). In addition, it will be determined if subjects are being treated for diagnosed dyslipidemia (high cholesterol) according to the National Cholesterol Educational Program (NCEP) guidelines.
The proposed pilot study aims to better understand the problem of Coronary Heart Disease in individuals with Spinal Cord Injury, specifically CCS in SCI, when compared to the general population.
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| Measure | Description | Time Frame |
|---|---|---|
| Percent Agreement Between Coronary Calcium Score (CCS) and National Cholesterol Education Program (NCEP) Guidelines | Participants were classified as high risk, intermediate high risk, intermediate low risk, and low risk based upon both their CCS and their LDL using NCEP Adult Treatment Panel III Guidelines. Those with CCS >/-400 were considered high risk, CCS=100-399 were intermediate high risk, CCS=1-99 intermediate low risk, and CCS=0 were low risk. The percent agreement between CCS and NCEP Guidelines was calculated by totaling the number of subjects who were classified in the same risk category and dividing by the total number of subjects | During single data collection. Average duration of injury was 24.4 years +/-9.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to NCEP Criteria | Determine the total percentage of subjects who should be on drug therapy by NCEP criteria and who are on drug therapy who have achieved their treatment goal as defined by NCEP criteria | During single data collection |
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Inclusion Criteria:
Exclusion Criteria:
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Male,Spinal Cord Injuries
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| Name | Affiliation | Role |
|---|---|---|
| Jesse Lieberman, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carolinas Rehabilitation | Charlotte | North Carolina | 28203 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21675362 | Result | Lieberman JA, Hammond FM, Barringer TA, Norton HJ, Goff DC Jr, Bockenek WL, Scelza WM. Comparison of coronary artery calcification scores and National Cholesterol Education program guidelines for coronary heart disease risk assessment and treatment paradigms in individuals with chronic traumatic spinal cord injury. J Spinal Cord Med. 2011;34(2):233-40. doi: 10.1179/107902610X12923394765733. | |
| 21528624 |
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Recruitment began in 2007 and was completed in 2008. All recruitment was done at the Carolinas Rehabilitation Outpatient SCI clinic
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Group |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Agreement Between Coronary Calcium Score (CCS) and National Cholesterol Education Program (NCEP) Guidelines | Participants were classified as high risk, intermediate high risk, intermediate low risk, and low risk based upon both their CCS and their LDL using NCEP Adult Treatment Panel III Guidelines. Those with CCS >/-400 were considered high risk, CCS=100-399 were intermediate high risk, CCS=1-99 intermediate low risk, and CCS=0 were low risk. The percent agreement between CCS and NCEP Guidelines was calculated by totaling the number of subjects who were classified in the same risk category and dividing by the total number of subjects | Posted | Number | percent agreement | During single data collection. Average duration of injury was 24.4 years +/-9.5 years |
|
September 2007-November 2008
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Study Group |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jesse Lieberman | Carolinas Healthcare System | 704-355-0649 | Jesse.Lieberman@Carolinashealthcare.org |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D006331 | Heart Diseases |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| Result |
| Lieberman JA, Hammond FM, Barringer TA, Goff DC Jr, Norton HJ, Bockenek WL, Scelza WM. Adherence with the National Cholesterol Education Program guidelines in men with chronic spinal cord injury. J Spinal Cord Med. 2011;34(1):28-34. doi: 10.1179/107902610x12883422813589. |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
|
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| Secondary | Adherence to NCEP Criteria | Determine the total percentage of subjects who should be on drug therapy by NCEP criteria and who are on drug therapy who have achieved their treatment goal as defined by NCEP criteria | 38 subjects completed the data collection | Posted | Number | percentage of participants | During single data collection |
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| 0 |
| 45 |
| 0 |
| 45 |
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| D014947 | Wounds and Injuries |
| D002318 | Cardiovascular Diseases |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |