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

NCT ID: NCT01065896

Last Updated: 2012-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-02-28

Study Completion Date

2012-02-29

Brief Summary

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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

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Conditions

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Spinal Cord Injury

Keywords

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spinal cord injury coronary artery disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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US Department of Veterans Affairs

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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William Bauman, MD

Role: PRINCIPAL_INVESTIGATOR

VA Medical Center, Bronx

Locations

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VA Medical Center, Bronx

The Bronx, New York, United States

Site Status

Countries

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United States

Other Identifiers

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B4162C-12

Identifier Type: -

Identifier Source: org_study_id