- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00431405
Cardiovascular Outcomes in the VA's Rheumatoid Arthritis(VARA) Population
Assessing Risk of Cardiovascular Events in RA Patients Using a Retrospective Cohort From the VARA Registry
Rheumatoid arthritis (RA) is a symmetric, peripheral polyarthritis of uncertain etiology that can lead to joint deformity and destruction. However, the effects of RA are not confined simply to joint involvement. Virtually every organ system can be affected by RA if left untreated. Of particular note is RA's affect on the cardiovascular system. RA patients have a reduced lifespan compared to the general population primarily due to an increased cardiovascular disease burden (1). Recently, RA has been linked to the development of preclinical atherosclerosis in the carotid arteries as measured by ultrasonography (2). Women with RA have also been shown to have an increased incidence of nonfatal myocardial infarctions (3). Despite these studies showing the effects of RA on the cardiovascular disease burden of those who are afflicted, no study to date has compared the number of cardiovascular events in a large RA patient population to a risk factor and age matched control group. Consequently it is the goal of this study to determine whether the cardiovascular event ratio in an RA patient cohort exceeds an age and risk factor matched cohort of non-RA patients. This study will also attempt to ascertain whether specific cardiovascular risk factors contribute to the cardiovascular morbidity and mortality associated with RA and if any standard cardiovascular medicines disproportionately contribute to patient outcome.
Hypothesis: Given the increased cardiovascular disease burden associated with RA patients they are likely to suffer from a statistically significant increased risk of cardiovascular events when compared to an age and risk factor matched cohort.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding
Kontakter og lokationer
Studiesteder
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Texas
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Dallas, Texas, Forenede Stater, 75216
- Dallas VA Medical Center-Rheumatology
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Patient included in the VA Rheumatoid Arthritis database previously, who by definition will meet criteria for RA.
- Control subjects will not carry the diagnosis of RA.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Defineret befolkning
- Tidsperspektiver: Tilbagevirkende kraft
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Salahuddin Kazi, MBBS, Dallas VA Medical Center
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- COVARA
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Kliniske forsøg med Koronar sygdom
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IRCCS Policlinico S. DonatoRekrutteringAnomalous aorta origin of the coronary artery (AAOCA)Italien