Rheumatoid Arthritis Clinical Trial
Official title:
Analysis of Endothelial Cells in Rheumatoid Arthritis
NCT number | NCT02468986 |
Other study ID # | STU 012011-034 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 2011 |
Est. completion date | December 2020 |
Verified date | March 2021 |
Source | University of Texas Southwestern Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Heart disease is the major contributor of early death in rheumatoid arthritis (RA) and is not influenced by traditional risk factors. Blood vessel dysfunction has been associated with heart disease and complications such as heart attack. The vessel dysfunction is thought to be mediated in part to inflammation. RA patients have evidence of vessel dysfunction seen on ultrasound that improves after medications are given. The purpose of this study is to evaluate patients with controlled or uncontrolled rheumatoid arthritis to determine if there is a difference in the protein expression in the cells that line the blood vessels compared to healthy people.
Status | Completed |
Enrollment | 56 |
Est. completion date | December 2020 |
Est. primary completion date | August 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: Rheumatoid arthritis: - Age 18-75 years - Rheumatoid arthritis defined by 1987 American College of Rheumatology criteria - Attending clinic at University of Texas Southwestern Aston Clinic for Rheumatology or Parkland Arthritis Clinic. Healthy controls: - Age 18-75 years. Exclusion Criteria: Rheumatoid arthritis: - Insulin dependent diabetes - Cardiovascular or Cerebrovascular disease - Tobacco use in last 24 months - Uncontrolled blood pressure - Uncontrolled cholesterol - Pregnant or nursing - Prednisone greater than 10mg per day - Stable methotrexate dose for less than 4 weeks - Undergoing Infliximab infusions Healthy controls: - Insulin dependent diabetes - Cardiovascular or Cerebrovascular disease - Tobacco use in last 24 months - Uncontrolled high blood pressure - Uncontrolled cholesterol - Pregnant or nursing |
Country | Name | City | State |
---|---|---|---|
United States | Parkland Memorial Hospital | Dallas | Texas |
United States | University of Texas Southwestern | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Texas Southwestern Medical Center | American Heart Association, Bristol-Myers Squibb |
United States,
del Rincón ID, Williams K, Stern MP, Freeman GL, Escalante A. High incidence of cardiovascular events in a rheumatoid arthritis cohort not explained by traditional cardiac risk factors. Arthritis Rheum. 2001 Dec;44(12):2737-45. — View Citation
Galarraga B, Khan F, Kumar P, Pullar T, Belch JJ. C-reactive protein: the underlying cause of microvascular dysfunction in rheumatoid arthritis. Rheumatology (Oxford). 2008 Dec;47(12):1780-4. doi: 10.1093/rheumatology/ken386. Epub 2008 Oct 14. — View Citation
Gonzalez-Juanatey C, Llorca J, Sanchez-Andrade A, Garcia-Porrua C, Martin J, Gonzalez-Gay MA. Short-term adalimumab therapy improves endo-thelial function in patients with rheumatoid arthritis refractory to infliximab. Clin Exp Rheumatol. 2006 May-Jun;24(3):309-12. — View Citation
Maradit-Kremers H, Crowson CS, Nicola PJ, Ballman KV, Roger VL, Jacobsen SJ, Gabriel SE. Increased unrecognized coronary heart disease and sudden deaths in rheumatoid arthritis: a population-based cohort study. Arthritis Rheum. 2005 Feb;52(2):402-11. Review. — View Citation
Neunteufl T, Katzenschlager R, Hassan A, Klaar U, Schwarzacher S, Glogar D, Bauer P, Weidinger F. Systemic endothelial dysfunction is related to the extent and severity of coronary artery disease. Atherosclerosis. 1997 Feb 28;129(1):111-8. — View Citation
Oemar BS, Tschudi MR, Godoy N, Brovkovich V, Malinski T, Lüscher TF. Reduced endothelial nitric oxide synthase expression and production in human atherosclerosis. Circulation. 1998 Jun 30;97(25):2494-8. — View Citation
Schwartz R, Osborne-Lawrence S, Hahner L, Gibson LL, Gormley AK, Vongpatanasin W, Zhu W, Word RA, Seetharam D, Black S, Samols D, Mineo C, Shaul PW. C-reactive protein downregulates endothelial NO synthase and attenuates reendothelialization in vivo in mice. Circ Res. 2007 May 25;100(10):1452-9. Epub 2007 Apr 19. — View Citation
Vaudo G, Marchesi S, Gerli R, Allegrucci R, Giordano A, Siepi D, Pirro M, Shoenfeld Y, Schillaci G, Mannarino E. Endothelial dysfunction in young patients with rheumatoid arthritis and low disease activity. Ann Rheum Dis. 2004 Jan;63(1):31-5. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Endothelial cell protein expression by immunofluorescence microscopy of endothelial nitric oxide synthase, nitrotyrosine, nuclear factor kappa B. | Immunofluorescence microscopy of frozen endothelial cells will be processed in batches to reduce bias. Cells are assessed for individual protein expression at study entry. Repeated collection of cells will not been done. | Cells are immediately processed following extraction and placed in -80 degree C freezer. Cells are then analyzed by immunofluorescence microscopy in batches of subjects. Patient is followed-up 24 hours after by phone. | |
Secondary | Serum cytokines analysis by cytometric bead array | Interleukin-1, Interleukin-6, Tumor Necrosis Factor -alpha | Measured once upon enrollment into study. Patient is followed-up 24 hours after by phone. | |
Secondary | Flow mediated dilation assessed in the brachial artery by ultrasound | Measured once upon enrollment into study. Patient is followed-up 24 hours after by phone. |
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