Clinical trial NCT01204632: Cardiometabolic Risk, Obesity and Cardiovascular Disease in People With Spinal Cord Injury
Official title: Cardiometabolic Risk, Obesity and Cardiovascular Disease in People With Spinal Cord Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Injury
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: MedStar National Rehabilitation Network
First posted: 2010-09-17
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample of healthy persons with spinal cord injury

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Body composition
timeFrame: 1 visit
Secondary outcomes:
measure: Carotid Intima-Media Thickness
timeFrame: 1 visit
measure: Coronary Artery Calcium
timeFrame: 1 visit
measure: Atherosclerotic plaques
timeFrame: 1 visit
measure: Area Under the Curve (AUC)for lipemia
timeFrame: 1 visit
measure: Area Under the Curve (AUC) for glycemia
timeFrame: 1 visit
measure: Area Under the Curve (AUC)for vascular inflammation
timeFrame: 1 visit
Other outcomes:
Locations:
city: Miami
country: United States
facility: The Miami Project to Cure Paralysis
state: Florida
Study officials:
affiliation: University of Miami Miller School of Medicine, The Miami Project to Cure Paralysis
name: Mark S Nash, PhD
role: PRINCIPAL_INVESTIGATOR
References: