Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00037336
Status:
COMPLETED
Last Update Posted:
2014-03-17
First Post:
2002-05-16
Brief Title:
Atherosclerosis in Rheumatoid Arthritis
Sponsor:
Vanderbilt University
Organization:
Vanderbilt University
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2014-03
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:
To test the theory that accelerated inflammation-promoted atherosclerosis occurs in patients with rheumatoid arthritis RA
Detailed Description:
BACKGROUND
Premature cardiovascular disease is a major cause of mortality in rheumatoid arthritis RA The mechanisms underlying accelerated atherosclerosis and its relationship to inflammation in RA are poorly understood Recent studies indicate that inflammation through the effects of inflammatory cytokines and oxidative stress through lipid peroxidation are important in the pathogenesis of atherosclerosis The studys hypothesis is that accelerated inflammation-promoted atherosclerosis occurs in RA
DESIGN NARRATIVE
The study tests the hypotheses 1 that structural and functional vascular damage is more frequent and more severe in patients with established RA than matched controls and is related to cumulative disease severity 2 that this impairment of vascular integrity is associated with clinical and laboratory markers of inflammation plasma homocysteine concentrations and oxidative stress To address these two hypotheses the relationship between longstanding inflammation and vascular integrity will be determined in a cross-sectional study of 75 patients with established RA in whom prospectively obtained clinical data are available for 15 years and 75 matched non-RA controls Endothelium-dependent flow-mediated dilation of the brachial artery measured by ultrasound and coronary calcium volume measured by electron beam computed tomography EBCT will provide functional and structural measures of vascular integrity respectively F2-isoprostane excretion a reliable index of lipid peroxidation in vivo homocysteine and lipid concentrations will be measured Vascular integrity oxidative stress lipids and homocysteine will be compared in controls and RA patients In the RA patients the relationship between RA activity and damage indices obtained over 15 years and vascular function and damage measures will be determined Using the same techniques we will address hypothesis 3 that the rate of progression of vascular disease in patients with early RA can be altered by control of inflammation In a prospective cohort of 100 patients with early RA receiving usual clinical care and 100 matched non-RA controls followed over 24 months the relationship between clinical and biochemical measures of inflammation and vascular integrity will be determined by comparing responders and non-responders These studies will provide a basic understanding of the interrelationship between inflammation lipids oxidative stress and vascular damage and will suggest strategies for reversing or preventing such damage in RA and potentially other diseases
Premature cardiovascular disease is a major cause of mortality in rheumatoid arthritis RA The mechanisms underlying accelerated atherosclerosis and its relationship to inflammation in RA are poorly understood Recent studies indicate that inflammation through the effects of inflammatory cytokines and oxidative stress through lipid peroxidation are important in the pathogenesis of atherosclerosis The studys hypothesis is that accelerated inflammation-promoted atherosclerosis occurs in RA
DESIGN NARRATIVE
The study tests the hypotheses 1 that structural and functional vascular damage is more frequent and more severe in patients with established RA than matched controls and is related to cumulative disease severity 2 that this impairment of vascular integrity is associated with clinical and laboratory markers of inflammation plasma homocysteine concentrations and oxidative stress To address these two hypotheses the relationship between longstanding inflammation and vascular integrity will be determined in a cross-sectional study of 75 patients with established RA in whom prospectively obtained clinical data are available for 15 years and 75 matched non-RA controls Endothelium-dependent flow-mediated dilation of the brachial artery measured by ultrasound and coronary calcium volume measured by electron beam computed tomography EBCT will provide functional and structural measures of vascular integrity respectively F2-isoprostane excretion a reliable index of lipid peroxidation in vivo homocysteine and lipid concentrations will be measured Vascular integrity oxidative stress lipids and homocysteine will be compared in controls and RA patients In the RA patients the relationship between RA activity and damage indices obtained over 15 years and vascular function and damage measures will be determined Using the same techniques we will address hypothesis 3 that the rate of progression of vascular disease in patients with early RA can be altered by control of inflammation In a prospective cohort of 100 patients with early RA receiving usual clinical care and 100 matched non-RA controls followed over 24 months the relationship between clinical and biochemical measures of inflammation and vascular integrity will be determined by comparing responders and non-responders These studies will provide a basic understanding of the interrelationship between inflammation lipids oxidative stress and vascular damage and will suggest strategies for reversing or preventing such damage in RA and potentially other diseases
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL067964 | NIH | None | httpsreporternihgovquickSearchR01HL067964 |