Cardiometabolic Risk, Obesity and Cardiovascular Disease... | NCT01204632

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

NCT01204632

Sponsor

University of Miami

Status

Completed

Last Update Posted

Feb 18, 2016Estimated

Enrollment

74Actual

Phase

Not provided

Conditions

Spinal Cord Injury

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2010

Primary Completion Date

Dec 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Sep 16, 2010

First Submission Date that Met QC Criteria

Sep 16, 2010

First Posted Date

Sep 17, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 17, 2016

Last Update Posted Date

Feb 18, 2016Estimated

Name	Class
MedStar National Rehabilitation Network	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

74Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Body composition	The percent of muscle and fat in each participants' body will be measured by dual x-ray absorptiometry (DEXA) scan.	1 visit

Secondary Outcomes

Measure	Description	Time Frame
Carotid Intima-Media Thickness	Carotid intima-media thickness (IMT) measurements will be generated using B-mode external vascular ultrasound.	1 visit
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.

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Community sample of healthy persons with spinal cord injury

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mark S Nash, PhD	University of Miami Miller School of Medicine, The Miami Project to Cure Paralysis	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Miami Project to Cure Paralysis		Miami	Florida	33136	United States

Condition Browse Module

MeSH Terms

ID	Term
D013119	Spinal Cord Injuries

Ancestor Terms

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D020196	Trauma, Nervous System

Browse Leaves

Not provided

Browse Branches

Not provided