Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2025-12-25 @ 7:09 PM
Study NCT ID:
NCT01204632
Status:
COMPLETED
Last Update Posted:
2016-02-18
First Post:
2010-09-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cardiometabolic Risk, Obesity and Cardiovascular Disease in People With Spinal Cord Injury
Sponsor:
University of Miami
Organization:
Study Overview
Official Title:
Cardiometabolic Risk, Obesity and Cardiovascular Disease in People With Spinal Cord Injury
Status:
COMPLETED
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: