Heart Diseases, Spinal Cord Injuries
Conditions
Keywords
spinal cord injury, Coronary artery calcium, Dyslipidemia
Brief summary
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.
Interventions
None listed
Sponsors
Wake Forest University Health Sciences
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
MALE
Age
45 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Male * Spinal Cord Injury due to externally inflicted trauma * \> or = 10 years post injury * American Spinal Injury Association (ASIA) Scale A,B, or C * 45 to 70 years of age * Communication and comprehension sufficient for compliance with all testing procedures * Voluntary informed consent
Exclusion criteria
* Spinal Cord Injury of non-traumatic etiology * Injury \< 10 years prior to enrollment * Known Coronary Heart Disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Agreement Between Coronary Calcium Score (CCS) and National Cholesterol Education Program (NCEP) Guidelines | During single data collection. Average duration of injury was 24.4 years +/-9.5 years | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to NCEP Criteria | During single data collection | 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 |
Countries
United States
Participant flow
Recruitment details
Recruitment began in 2007 and was completed in 2008. All recruitment was done at the Carolinas Rehabilitation Outpatient SCI clinic
Participants by arm
| Arm | Count |
|---|---|
| Study Group | 45 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Protocol Violation | 3 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Study Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 42 Participants |
| Age, Continuous | 55 years STANDARD_DEVIATION 7.2 |
| Region of Enrollment United States | 45 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 45 |
| serious Total, serious adverse events | 0 / 45 |
Outcome results
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
Time frame: During single data collection. Average duration of injury was 24.4 years +/-9.5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Study Group | Percent Agreement Between Coronary Calcium Score (CCS) and National Cholesterol Education Program (NCEP) Guidelines | 18 percent agreement |
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
Time frame: During single data collection
Population: 38 subjects completed the data collection
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Study Group | Adherence to NCEP Criteria | 39.5 percentage of participants |