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Study of Venous Endothelial Cells in Rheumatoid Arthritis

30. mars 2021 oppdatert av: Elizabeth Blair Solow, University of Texas Southwestern Medical Center

Analysis of Endothelial Cells in Rheumatoid Arthritis

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.

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

The study will consist of a cross sectional analysis of venous endothelial cells in rheumatoid arthritis patients who have controlled or uncontrolled disease and healthy controls. We will collect venous endothelial cells by placing an IV in antegrade position in the forearm and a thin wire will be inserted to collect the cells from the inner lining of the vein. The cells will processed and stained for markers of endothelial function and oxidative stress including endothelial nitric oxide synthase (eNOS), phospho-eNOS, nuclear factor kappa B (NFκB), and nitrotyrosine using immunofluorescence technique. Flow mediated dilation (FMD) by ultrasound of the brachial artery on the contralateral arm will be used as an additional marker of endothelial function. A blood sample will be taken for analysis of inflammatory markers (sedimentation rate, C-reactive protein) and cytokine analysis (IL-1, IL-6, TNFa) by cytokine bead array and flow cytometry.

Studietype

Observasjonsmessig

Registrering (Faktiske)

56

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Texas
      • Dallas, Texas, Forente stater, 75390
        • University of Texas Southwestern
      • Dallas, Texas, Forente stater, 75235
        • Parkland Memorial Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Rheumatoid arthritis patients will be selected from arthritis clinics associated with UT Southwestern Medical Center and Parkland Memorial Hospital. Healthy controls will be collected from primary care clinics who refer to these specialty clinics.

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Uncontrolled Rheumatoid Arthritis

18-75 years old; Rheumatoid arthritis, defined by 1987 American College Rheumatology criteria; Attending clinic at Aston Center for Rheumatology or Parkland Rheumatology Clinic; Uncontrolled: Patients will be labeled as uncontrolled RA if Disease Activity Score (DAS) score is >3.2 and C-reactive protein (mg/dL) elevated above normal range.

Excluding: Insulin dependent diabetes; Cardiovascular or Cerebrovascular disease (history of myocardial infarction, stroke, peripheral vascular disease); Tobacco use in the past 24 months; Uncontrolled hypertension (BP > 150/90) in the past 3 months; Uncontrolled hyperlipidemia (LDL>160) in the past 6 months; Pregnant or nursing.
Controlled Rheumatoid Arthritis
18-75 years old; Rheumatoid arthritis, defined by 1987 American College Rheumatology criteria; Attending clinic at Aston Center for Rheumatology or Parkland Rheumatology Clinic; Controlled: Disease activity score (DAS) <3.2, normal C-reactive protein. Excluding: Insulin dependent diabetes; Cardiovascular or Cerebrovascular disease (history of myocardial infarction, stroke, peripheral vascular disease); Tobacco use in the past 24 months; Uncontrolled hypertension (BP > 150/90) in the past 3 months; Uncontrolled hyperlipidemia (LDL>160) in the past 6 months; Pregnant or nursing.
Healthy Controls
18-75 years old. Excluding: Insulin dependent diabetes; Cardiovascular or Cerebrovascular disease (history of myocardial infarction, stroke, peripheral vascular disease); Tobacco use in the past 24 months; Uncontrolled hypertension (BP > 150/90) in the past 3 months; Uncontrolled hyperlipidemia (LDL>160) in the past 6 months; Pregnant or nursing.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Endothelial cell protein expression by immunofluorescence microscopy of endothelial nitric oxide synthase, nitrotyrosine, nuclear factor kappa B.
Tidsramme: 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.
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.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Serum cytokines analysis by cytometric bead array
Tidsramme: Measured once upon enrollment into study. Patient is followed-up 24 hours after by phone.
Interleukin-1, Interleukin-6, Tumor Necrosis Factor -alpha
Measured once upon enrollment into study. Patient is followed-up 24 hours after by phone.
Flow mediated dilation assessed in the brachial artery by ultrasound
Tidsramme: Measured once upon enrollment into study. Patient is followed-up 24 hours after by phone.
Measured once upon enrollment into study. Patient is followed-up 24 hours after by phone.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Texas Southwestern Medical Center

Samarbeidspartnere

Bristol-Myers Squibb
American Heart Association

Etterforskere

  • Hovedetterforsker: Elizabeth B Solow, MD, University of Texas
  • Hovedetterforsker: David Karp, MD, PhD, University of Texas

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. august 2011

Primær fullføring (Faktiske)

1. august 2019

Studiet fullført (Faktiske)

1. desember 2020

Datoer for studieregistrering

Først innsendt

6. mars 2014

Først innsendt som oppfylte QC-kriteriene

8. juni 2015

Først lagt ut (Anslag)

11. juni 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. april 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. mars 2021

Sist bekreftet

1. mars 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • STU 012011-034

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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