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

This study has been completed.
Sponsor:
Collaborator:
MedStar National Rehabilitation Network
Information provided by (Responsible Party):
Mark S. Nash, Ph.D., FACSM, University of Miami
ClinicalTrials.gov Identifier:
NCT01204632
First received: September 16, 2010
Last updated: February 17, 2016
Last verified: February 2016
  Purpose
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.

Condition
Spinal Cord Injury

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cardiometabolic Risk, Obesity and Cardiovascular Disease in People With Spinal Cord Injury

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • Body composition [ Time Frame: 1 visit ] [ Designated as safety issue: No ]
    The percent of muscle and fat in each participants' body will be measured by dual x-ray absorptiometry (DEXA) scan.


Secondary Outcome Measures:
  • Carotid Intima-Media Thickness [ Time Frame: 1 visit ] [ Designated as safety issue: No ]
    Carotid intima-media thickness (IMT) measurements will be generated using B-mode external vascular ultrasound.

  • Coronary Artery Calcium [ Time Frame: 1 visit ] [ Designated as safety issue: No ]
    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.

  • Atherosclerotic plaques [ Time Frame: 1 visit ] [ Designated as safety issue: No ]
    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.

  • Area Under the Curve (AUC)for lipemia [ Time Frame: 1 visit ] [ Designated as safety issue: No ]
    Lipemia is assessed by the AUC for triglycerides during an oral glucose tolerance test.

  • Area Under the Curve (AUC) for glycemia [ Time Frame: 1 visit ] [ Designated as safety issue: No ]
    Glycemia is assessed by the AUC for glucose and insulin during an oral glucose tolerance test.

  • Area Under the Curve (AUC)for vascular inflammation [ Time Frame: 1 visit ] [ Designated as safety issue: No ]
    The pro-atherogenic inflammatory mediators are AUCs for C-reactive protein and Interleukin-6 during an oral glucose tolerance test.


Enrollment: 74
Study Start Date: March 2010
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Community sample of healthy persons with spinal cord injury
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01204632

Locations
United States, Florida
The Miami Project to Cure Paralysis
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
MedStar National Rehabilitation Network
Investigators
Principal Investigator: Mark S Nash, PhD University of Miami Miller School of Medicine, The Miami Project to Cure Paralysis
  More Information

Additional Information:
Responsible Party: Mark S. Nash, Ph.D., FACSM, Professor, University of Miami
ClinicalTrials.gov Identifier: NCT01204632     History of Changes
Other Study ID Numbers: TMP-MN-008 
Study First Received: September 16, 2010
Last Updated: February 17, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Wounds and Injuries
Cardiovascular Diseases
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System

ClinicalTrials.gov processed this record on August 30, 2016