Cardiometabolic Risk, Obesity and Cardiovascular Disease in People With Spinal Cord Injury

University of Miami

Status: Completed

Conditions: Spinal Cord Injury

Study type: Observational

Funder types: Other

Identifiers

NCT01204632

TMP-MN-008

Details and patient eligibility

About

The purpose of this study is to develop and field-test new tools for diagnosis and hazard assessment of cardiometabolic risk (CMR) in people with chronic spinal cord injury (SCI) and to advance the evidence base with much needed information on CMR and cardiovascular disease (CVD) burden in people with SCI. These data can be used to develop screening guidelines for early identification and prevention of CMR in SCI, as well as targeted approaches to primary disease management.

Full description

Unlike current assessments utilizing lipid scores, the new system will be anchored in more reliable measurements of cardiovascular disease (CVD) burden using contemporary surrogate end points of coronary artery calcium (CAC) score, coronary CT angiography and carotid intima media thickness (CIMT). By the end of the 5-year funding cycle we will develop an updatable web-based cardiometabolic risk assessment tool (RISK) that will allow clinicians and SCI consumers to quantify risk for a cardiovascular sentinel event (stroke, non-fatal heart attack, or death) and will also provide a body mass index (BMI) table adjusted for SCI.

Specific Aims:

1. Examine the relationships among surrogates of cardiovascular disease burden in persons with SCI and established cardiometabolic risks.
2. Identify significant predictors of cardiometabolic risk (CMR) that are unique to persons with specific levels of SCI.
3. Develop and validate SCI CMR assessment tool (RISK) based on cardiometabolic risk scores.
4. Develop and validate an adjusted BMI table for SCI.

Enrollment: 74 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• traumatic spinal cord injury between C4 and T12

• have a motor complete injury as classified as American Spinal Injury Association Impairment Scale (AIS) grade A or B

• injury for more than 1 year

• no known history of traumatic brain injury, cardiovascular disease or diabetes

• not currently taking any medications to treat cardiovascular disease or diabetes

• have multiple (i.e., 2+) of the following cardiometabolic risk factors:

  1. fasting triglyceride > 150 mg/dL
  2. HDLC < 40 mg/dL
  3. hs-CRP > 3.0
  4. body fat (by DEXA) >25% for males and 33% for females

Exclusion criteria

• history of allergy or hypersensitivity to fish and/or nuts
• undergoing anticoagulant therapies