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Vitamin D and Cardiovascular Events in Rheumatoid Arthritis

12 de octubre de 2016 actualizado por: Mette Herly, Odense University Hospital

Association Between Baseline Vitamin D Metabolite Levels and Risk of Cardiovascular Events in Rheumatoid Arthritis Patients. A Cohort Study With Patient-record Evaluated Outcomes.

The aim of the study is to evaluate cardiovascular events during long-term follow-up in Rheumatoid Arthritis. The primary outcome "any cardiovascular event" will be evaluated using systematic audits of patient records, and will be associated to low levels of vitamin D at baseline, to investigate the hypothesis that low levels of vitamin D can be part of a prediction model for cardiovascular disease in Rheumatoid Arthritis.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Cardiovascular morbidity and mortality is increased in patients with rheumatoid arthritis (RA), and among these patients, the prevalence of hypo-vitaminosis D is high. Low levels of vitamin D have been associated with elevated cardiovascular risk in healthy subjects. The objective of this study is to evaluate the risk of cardiovascular events in patients having low 25OHD-total levels at baseline compared to patients with sufficient levels, in an aggressively treated closed cohort of early-diagnosed RA patients.

The primary outcome will be the proportion of patients with any cardiovascular event, evaluated using systematic journal audits. Logistic regression models will be applied to test the hypothesis that there are more cardiovascular events in patients enrolled with a low level of vitamin D (< 50 nmol/l). Secondarily, Cox regression models, based on survival analysis, will be applied, to determine the extent to which independent variables (including different levels of vitamin D at baseline) predict not only whether a cardiovascular event occur, but also when it will occur.

Tipo de estudio

De observación

Inscripción (Actual)

160

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 75 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra de probabilidad

Población de estudio

Hundred-and-sixty early diagnosed and treatment-naive RA patients, recruited from five Danish University Clinics (Trial Centres) from October 1999 to October 2002

Descripción

Inclusion Criteria: Fulfilling ACR1987 (American College of Rheumatology 1987 classification criteria for Rheumatoid Arthritis) criteria for RA, disease duration < 6 months, 2 or more swollen joints and age between 18 and 75 years -

Exclusion Criteria: Glucocorticoid treatment 4 weeks prior to inclusion, previous use of DMARDs, malignancy, diastolic blood pressure > 90 mm Hg, elevated serum creatinine, infections with parvovirus B19, Hepatitis B, C and HIV, and any condition contraindicating the study medication.

-

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Rheumatoid arthritis patients
Participants in the original, parental trial
Otro: Baseline serum vitamin D level below 50 nmol/l
There is no medical intervention. The two groups are simple allocated depending on serum levels of D-total at the time of diagnosis
Otro: Baseline serum vitamin D level at or above 50 nmol/l
There is no medical intervention. The two groups are simple allocated depending on serum levels of D-total at the time of diagnosis

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Cardiovascular event
Periodo de tiempo: Observed in the time-period from inclusion to October the 10th 2016
Events will be recorded using systematic journal audits. A cardiovascular event will be further subclassified as shown in the secondary outcome measures, but for primary outcome measures; any cardiovascular event, including death, will serve as "an event"
Observed in the time-period from inclusion to October the 10th 2016

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Acute cardiovascular hospitalisation due to Myocardial Ischamia
Periodo de tiempo: Observed in the time-period from inclusion to October the 10th 2016

Non-fatal or fatal myocardial infarction, defined by National and International Guidelines (Thygesen et al. 1581-98).

Fatal myocardial infarction is defined as primary fatal event within 7 days, documented post mortem by autopsy, or by the definition of myocardial infarction according to European Guidelines (Thygesen et al. 1581-98) Death of myocardial infarction as a consequence of medical examination/procedure/surgery will be classified as procedure related death.

Acute Coronary Syndrome (ACS) includes acute ischaemic symptoms with eventual elevation in biomarkers or electrocardiographic changes which does not fulfil the criteria of acute myocardial infarction.

Angina Pectoris. Revascularisation procedures (Percutaneous Coronary Intervention (PCI) or Coronary bypass Graft (CABG).
Observed in the time-period from inclusion to October the 10th 2016
Acute cardiovascular hospitalisation due to hearth failure
Periodo de tiempo: Observed in the time-period from inclusion to October the 10th 2016

Patients with non-elective hospitalisation or death, minimum one overnight stay, with symptoms or findings of heart failure.

Death due to heart failure is defined as escalating heart failure symptoms prior to death.
Observed in the time-period from inclusion to October the 10th 2016
Acute cardiovascular hospitalisation due to stroke
Periodo de tiempo: Observed in the time-period from inclusion to October the 10th 2016
Cerebral haemorrhage, cerebral thromboembolism, Transitory Cerebral Ischemia (TCI) and others Stroke is defined as abrupt severe neurologic deficits, eventually with computer tomographic (CT) documentation. Death within 14 days after symptom-onset of stroke, and without other obviously reasons, is classified as caused by stroke
Observed in the time-period from inclusion to October the 10th 2016
Acute cardiovascular hospitalisation due to arrhythmias
Periodo de tiempo: Observed in the time-period from inclusion to October the 10th 2016
Atrial fibrillation or flutter, supraventricular tachycardia and others. Ventricular tachycardia, ventricular fibrillation and others. Death due to arrhythmia requires documentation, e.g. telemetric transcript, pacemaker or electrocardiogram
Observed in the time-period from inclusion to October the 10th 2016
Acute cardiovascular hospitalisation due to Procedure-related cardiovascular event
Periodo de tiempo: Observed in the time-period from inclusion to October the 10th 2016
Any cardiovascular event within 24 hours after cardiovascular medical examination/procedure/surgery.
Observed in the time-period from inclusion to October the 10th 2016
Acute cardiovascular hospitalisation due to other reasons
Periodo de tiempo: Observed in the time-period from inclusion to October the 10th 2016
Hospitalisation caused by other cardiovascular events, e.g. pulmonary embolism, rupture of aortic aneurism etc.
Observed in the time-period from inclusion to October the 10th 2016
Acute cardiovascular hospitalisation due to supposed cardiovascular reason
Periodo de tiempo: Observed in the time-period from inclusion to October the 10th 2016

Hospitalisation without any documented non-cardiovascular cause. All deaths which are not defined by the cardiovascular reasons mentioned above, and who are not caused by well-documented non-cardiovascular death.

All deaths without known reason
Observed in the time-period from inclusion to October the 10th 2016
Acute non-cardiovascular hospitalisation due to cancer
Periodo de tiempo: Observed in the time-period from inclusion to October the 10th 2016
Acute hospitalisation due to cancer
Observed in the time-period from inclusion to October the 10th 2016
Acute non-cardiovascular hospitalisation due to infection
Periodo de tiempo: Observed in the time-period from inclusion to October the 10th 2016
Acute hospitalisation due to infection
Observed in the time-period from inclusion to October the 10th 2016
Acute non-cardiovascular hospitalisation due to respiratory disease
Periodo de tiempo: Observed in the time-period from inclusion to October the 10th 2016
Acute hospitalisation due to respiratory disease
Observed in the time-period from inclusion to October the 10th 2016
Acute non-cardiovascular hospitalisation due to trauma
Periodo de tiempo: Observed in the time-period from inclusion to October the 10th 2016
Acute hospitalisation due to trauma
Observed in the time-period from inclusion to October the 10th 2016
Acute non-cardiovascular hospitalisation due to suicide
Periodo de tiempo: Observed in the time-period from inclusion to October the 10th 2016
Acute - hospitalisation due to suicide
Observed in the time-period from inclusion to October the 10th 2016
Acute non-cardiovascular hospitalisation due to other reasons
Periodo de tiempo: Observed in the time-period from inclusion to October the 10th 2016
Acute hospitalisation du to other non-cardiovascular reasons, than those previous mentioned
Observed in the time-period from inclusion to October the 10th 2016
Elective cardiovascular hospitalisation due to myocardial ischemia
Periodo de tiempo: Observed in the time-period from inclusion to October the 10th 2016
Observed in the time-period from inclusion to October the 10th 2016
Elective cardiovascular hospitalisation due to arrhythmia
Periodo de tiempo: Observed in the time-period from inclusion to October the 10th 2016
Observed in the time-period from inclusion to October the 10th 2016
Elective cardiovascular hospitalisation due to heart failure
Periodo de tiempo: Observed in the time-period from inclusion to October the 10th 2016
Observed in the time-period from inclusion to October the 10th 2016
Elective cardiovascular hospitalisation due to other cardiovascular reasons
Periodo de tiempo: Observed in the time-period from inclusion to October the 10th 2016
Observed in the time-period from inclusion to October the 10th 2016
Elective non-cardiovascular hospitalisation due to cancer
Periodo de tiempo: Observed in the time-period from inclusion to October the 10th 2016
Observed in the time-period from inclusion to October the 10th 2016
Elective non-cardiovascular hospitalisation due to infection
Periodo de tiempo: Observed in the time-period from inclusion to October the 10th 2016
Observed in the time-period from inclusion to October the 10th 2016
Elective non-cardiovascular hospitalisation due to respiratory disease
Periodo de tiempo: Observed in the time-period from inclusion to October the 10th 2016
Observed in the time-period from inclusion to October the 10th 2016
Elective non-cardiovascular hospitalisation due to trauma
Periodo de tiempo: Observed in the time-period from inclusion to October the 10th 2016
Observed in the time-period from inclusion to October the 10th 2016
Elective non-cardiovascular hospitalisation due to suicide
Periodo de tiempo: Observed in the time-period from inclusion to October the 10th 2016
Observed in the time-period from inclusion to October the 10th 2016
Witnessed, sudden cardiovascular death
Periodo de tiempo: Observed in the time-period from inclusion to October the 10th 2016
Death is witnessed and abrupt within one hour after symptom-onset
Observed in the time-period from inclusion to October the 10th 2016
Non-witnessed, sudden cardiovascular death
Periodo de tiempo: Observed in the time-period from inclusion to October the 10th 2016
Non-witnessed death with no obvious non-cardiovascular reasons (found death)
Observed in the time-period from inclusion to October the 10th 2016
Non-sudden cardiovascular death
Periodo de tiempo: Observed in the time-period from inclusion to October the 10th 2016
Death due to any of the cardiovascular caused previously mentioned, more than one hour after symptom-onset
Observed in the time-period from inclusion to October the 10th 2016

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Odense University Hospital

Colaboradores

Pfizer
University of Southern Denmark
Region of Southern Denmark
Odense Patient Data Explorative Network
The Danish Rheumatism Association

Investigadores

  • Silla de estudio: Torkell Ellingsen, MD, Phd, Odense University Hospital

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de octubre de 1999

Finalización primaria (Actual)

1 de octubre de 2016

Finalización del estudio (Actual)

1 de octubre de 2016

Fechas de registro del estudio

Enviado por primera vez

12 de octubre de 2016

Primero enviado que cumplió con los criterios de control de calidad

12 de octubre de 2016

Publicado por primera vez (Estimar)

13 de octubre de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

13 de octubre de 2016

Última actualización enviada que cumplió con los criterios de control de calidad

12 de octubre de 2016

Última verificación

1 de octubre de 2016

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 3-3013-930/1/

Plan de datos de participantes individuales (IPD)

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INDECISO

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