Clinical trial NCT01065896: Coronary Computed Tomography (CT) to Measure Coronary Calcification in Spinal Cord Injury (SCI)
Official title: The Use of Non-invasive Multidetector Coronary Computed Tomography Imaging for the Assessment of Coronary Calcification in Persons With Spinal Cord Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Injury
Keywords: spinal cord injury
coronary artery disease
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2010-02-09
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: SCI subjects will be included in the study if they have moderate or high risk for coronary heart disease, who have participated in a previous screening study.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Quantification of coronary calcium
timeFrame: 2 years
Secondary outcomes:
measure: Determine the relationship between calcification scores and vascular reactivity
timeFrame: 2 years
Other outcomes:
Locations:
city: Bronx
country: United States
facility: VA Medical Center, Bronx
state: New York
Study officials:
affiliation: VA Medical Center, Bronx
name: William Bauman, MD
role: PRINCIPAL_INVESTIGATOR
References: