AzTrials
AzTrials

Spinal Cord InjuryNCT01204632

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

An observational study of Spinal Cord Injury, run by University of Miami at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Spinal Cord Injury
How many people
74 participants
Where
1 siteUnited States
Study dates
Mar 2010to Dec 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Community sample of healthy persons with spinal cord injury

Who may be able to join

  • 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:
Show all 10Show fewer
  • fasting triglyceride > 150 mg/dL
  • HDLC < 40 mg/dL
  • hs-CRP > 3.0
  • body fat (by DEXA) >25% for males and 33% for females

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The Miami Project to Cure Paralysis

    Miami, Florida, 33136

Other trials in United States

About this study

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.

Read the 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.
Medical subject headings
Spinal Cord Injuries

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body composition

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

    Measured: 1 visit

Secondary outcomes (6)

  1. Carotid Intima-Media Thickness

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

    Measured: 1 visit

  2. Coronary Artery Calcium

    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.

    Measured: 1 visit

  3. Atherosclerotic plaques

    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.

    Measured: 1 visit

  4. Area Under the Curve (AUC)for lipemia

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

    Measured: 1 visit

  5. Area Under the Curve (AUC) for glycemia

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

    Measured: 1 visit

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

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

    Measured: 1 visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2010 (estimated)
  2. Study startMar 2010
  3. Primary completionDec 2015
  4. Study completionDec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01204632
Sponsor's protocol ID
TMP-MN-008
Status last verified
Feb 2016
First submitted
16 Sep 2010
Last updated
18 Feb 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Spinal Cord Injury, run by University of Miami at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body composition (time frame: 1 visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01204632.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in