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

NCT01065896 | Completed

• 1 other identifier: B4162C-12
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury

Keywords

spinal cord injury; coronary artery disease

Outcome Measures

Primary Outcomes (1)

• Quantification of coronary calcium

  2 years

Secondary Outcomes (1)

• Determine the relationship between calcification scores and vascular reactivity

  2 years

Study Arms (1)

Group 1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Male or female, 18 to 70 years of age;
• Chronic (e.g., duration of injury at least 6 months), stable SCI (regardless of level of lesion or completeness of injury);
• Concurrently participating in or previously completed protocol # 0454-06-073, "Risk Factors for Coronary Heart Disease in Spinal Cord Injury: conventional and emerging".

You may not qualify if:

• Acute medical illness;
• Pregnancy (as determined by a pregnancy test \< 1 week of the study); and
• The presence of a chronic disease (i.e., heart disease, pulmonary disease, etc.);
• Inability to comply with breathing instructions.

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

VA Medical Center, Bronx

The Bronx, New York, 10468, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• William Bauman, MD

  VA Medical Center, Bronx

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2010
• First Posted: February 9, 2010
• Study Start: February 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: February 1, 2012
• Last Updated: October 3, 2012

Record last verified: 2012-10

Locations

US (1)