Skip to main content
OpenTrials
Completed

NCT Number: NCT01204632

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Spinal Cord Injury Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Miami Project to Cure Paralysis

Miami, Florida, 33136, United States

About this study

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:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • fasting triglyceride > 150 mg/dL
  • HDLC < 40 mg/dL
  • hs-CRP > 3.0
  • 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

Treatment and study plan

Primary outcomes

  1. Body composition

    Time frame: 1 visit

    The percent of muscle and fat in each participants' body will be measured by dual x-ray absorptiometry (DEXA) scan.

Secondary outcomes

  1. Carotid Intima-Media Thickness

    Time frame: 1 visit

    Carotid intima-media thickness (IMT) measurements will be generated using B-mode external vascular ultrasound.

  2. Coronary Artery Calcium

    Time frame: 1 visit

    Non-contrast cardiac CT will be used to measure coronary artery calcium, as the presence of any calcium detected in the coronary tree is diagnostic of atherosclerosis. The volume of calcium is quantified, providing a score of plaque burden analogous to a physiologic stress test. Coronary calcium scores directly correlate with risk of cardiac events, with higher scores indicating greater plaque burden and greater risk of cardiac events.

  3. Atherosclerotic plaques

    Time frame: 1 visit

    Noninvasive CT angiography will be used in visualizing both calcified and non-calcified atherosclerotic plaques. This technique provides much finer anatomic detail and provides an opportunity to further identify latent atherosclerosis risk through the detection of both calcified and noncalcified atherosclerosis.

  4. Area Under the Curve (AUC)for lipemia

    Time frame: 1 visit

    Lipemia is assessed by the AUC for triglycerides during an oral glucose tolerance test.

  5. Area Under the Curve (AUC) for glycemia

    Time frame: 1 visit

    Glycemia is assessed by the AUC for glucose and insulin during an oral glucose tolerance test.

  6. Area Under the Curve (AUC)for vascular inflammation

    Time frame: 1 visit

    The pro-atherogenic inflammatory mediators are AUCs for C-reactive protein and Interleukin-6 during an oral glucose tolerance test.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • MedStar National Rehabilitation Network

Registry information

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Sep 17, 2010
Registry last updated
Feb 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.