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

Spinal Cord Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01204632
• Other study ID #: TMP-MN-008
• Status: Completed
• Phase: N/A
• First received: September 16, 2010
• Last updated: February 17, 2016
• Start date: March 2010
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Spinal Cord Injuries
• Spinal Cord Injury

Locations

Country	Name	City	State
United States	The Miami Project to Cure Paralysis	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	MedStar National Rehabilitation Network

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body composition	The percent of muscle and fat in each participants' body will be measured by dual x-ray absorptiometry (DEXA) scan.	1 visit	No
Secondary	Carotid Intima-Media Thickness	Carotid intima-media thickness (IMT) measurements will be generated using B-mode external vascular ultrasound.	1 visit	No
Secondary	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.	1 visit	No
Secondary	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.	1 visit	No
Secondary	Area Under the Curve (AUC)for lipemia	Lipemia is assessed by the AUC for triglycerides during an oral glucose tolerance test.	1 visit	No
Secondary	Area Under the Curve (AUC) for glycemia	Glycemia is assessed by the AUC for glucose and insulin during an oral glucose tolerance test.	1 visit	No
Secondary	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.	1 visit	No

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