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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01065896
First Posted: February 9, 2010
Last Update Posted: October 3, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
  Purpose

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.


Condition
Spinal Cord Injury

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Use of Non-invasive Multidetector Coronary Computed Tomography Imaging for the Assessment of Coronary Calcification in Persons With Spinal Cord Injury

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Quantification of coronary calcium [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • Determine the relationship between calcification scores and vascular reactivity [ Time Frame: 2 years ]

Estimated Enrollment: 150
Study Start Date: February 2010
Study Completion Date: February 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01065896


Locations
United States, New York
VA Medical Center, Bronx
Bronx, New York, United States, 10468
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: William Bauman, MD VA Medical Center, Bronx
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01065896     History of Changes
Other Study ID Numbers: B4162C-12
First Submitted: February 8, 2010
First Posted: February 9, 2010
Last Update Posted: October 3, 2012
Last Verified: October 2012

Keywords provided by VA Office of Research and Development:
spinal cord injury
coronary artery disease

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Calcinosis
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Calcium Metabolism Disorders
Metabolic Diseases