Coronary Computed Tomography (CT) to Measure Coronary Calcification in Spinal Cord Injury (SCI)

Completed

• Conditions: Spinal Cord Injury

• Registration Number: NCT01065896
• Lead Sponsor: US Department of Veterans Affairs

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-08
• Study First Submitted QC: 2010-02-08
• Study First Posted: 2010-02-09
• Primary Completion: 2011-10
• Study Completion: 2012-02
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-02
• Last Update Posted: 2012-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Male or female, 18 to 70 years of age;
2. Chronic (e.g., duration of injury at least 6 months), stable SCI (regardless of level of lesion or completeness of injury);
3. Concurrently participating in or previously completed protocol # 0454-06-073, "Risk Factors for Coronary Heart Disease in Spinal Cord Injury: conventional and emerging".

Exclusion Criteria

1. Acute medical illness;
2. Pregnancy (as determined by a pregnancy test < 1 week of the study); and
3. The presence of a chronic disease (i.e., heart disease, pulmonary disease, etc.);
4. Inability to comply with breathing instructions.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quantification of coronary calcium	2 years

Secondary Outcome Measures

Name	Time	Method
Determine the relationship between calcification scores and vascular reactivity	2 years

Trial Locations

Locations (1)

VA Medical Center, Bronx; 🇺🇸 Bronx, New York, United States