Trial Outcomes & Findings for Coronary Heart Disease as Measured by Coronary Calcium Score Among Individuals With Chronic Traumatic Spinal Cord Injury (NCT NCT00628446)

Results Overview

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

Recruitment status

COMPLETED

Target enrollment

45 participants

Primary outcome timeframe

During single data collection. Average duration of injury was 24.4 years +/-9.5 years

Results posted on

2022-04-21

Participant Flow

Recruitment began in 2007 and was completed in 2008. All recruitment was done at the Carolinas Rehabilitation Outpatient SCI clinic

Participant milestones

Participant milestones
Measure	Study Group
Overall Study STARTED	45
Overall Study COMPLETED	38
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Study Group
Overall Study Lost to Follow-up	3
Overall Study Withdrawal by Subject	1
Overall Study Protocol Violation	3

Baseline Characteristics

Coronary Heart Disease as Measured by Coronary Calcium Score Among Individuals With Chronic Traumatic Spinal Cord Injury

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study Group n=45 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	42 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Age, Continuous	55 years STANDARD_DEVIATION 7.2 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	45 Participants n=5 Participants
Region of Enrollment United States	45 participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Study Group n=38 Participants Cross-sectional study group
Percent Agreement Between Coronary Calcium Score (CCS) and National Cholesterol Education Program (NCEP) Guidelines	18 percent agreement

SECONDARY outcome

Timeframe: During single data collection

Population: 38 subjects completed the 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

Outcome measures

Outcome measures
Measure	Study Group n=38 Participants Cross-sectional study group
Adherence to NCEP Criteria	39.5 percentage of participants

Adverse Events

Study Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jesse Lieberman

Carolinas Healthcare System

Phone: 704-355-0649

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place