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

NCT ID: NCT01204632

Last Updated: 2016-02-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 74 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2015-12-31

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.

Conditions

Spinal Cord Injury

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MedStar National Rehabilitation Network

OTHER

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Mark S. Nash, Ph.D., FACSM

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mark S Nash, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami Miller School of Medicine, The Miami Project to Cure Paralysis

Locations

The Miami Project to Cure Paralysis

Miami, Florida, United States

Countries

United States

Other Identifiers

TMP-MN-008

Identifier Type: -

Identifier Source: org_study_id