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

The Use of Non-invasive Multidetector Coronary Computed Tomography Imaging for the Assessment of Coronary Calcification in Persons With Spinal Cord Injury

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01065896

Enrollment

150

Registered

2010-02-09

Start date

2010-02-28

Completion date

2012-02-29

Last updated

2012-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injury

Keywords

spinal cord injury, coronary artery disease

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Quantification of coronary calcium	2 years

Secondary

Measure	Time frame
Determine the relationship between calcification scores and vascular reactivity	2 years

Countries

United States

Outcome results