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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01065896
First received: February 8, 2010
Last updated: October 2, 2012
Last verified: October 2012

February 8, 2010
October 2, 2012
February 2010
October 2011   (final data collection date for primary outcome measure)
Quantification of coronary calcium [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01065896 on ClinicalTrials.gov Archive Site
Determine the relationship between calcification scores and vascular reactivity [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

Spinal Cord Injury
Not Provided
Group 1
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
February 2012
October 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01065896
B4162C-12
No
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: William Bauman, MD VA Medical Center, Bronx
Department of Veterans Affairs
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP