Vitamin D and Cardiovascular Events in Rheumatoid Arthritis
Association Between Baseline Vitamin D Metabolite Levels and Risk of Cardiovascular Events in Rheumatoid Arthritis Patients. A Cohort Study With Patient-record Evaluated Outcomes.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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 di studio
Iscrizione (Effettivo)
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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.
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Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
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Rheumatoid arthritis patients
Participants in the original, parental trial
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There is no medical intervention.
The two groups are simple allocated depending on serum levels of D-total at the time of diagnosis
There is no medical intervention.
The two groups are simple allocated depending on serum levels of D-total at the time of diagnosis
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Cardiovascular event
Lasso di tempo: Observed in the time-period from inclusion to October the 10th 2016
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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"
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Observed in the time-period from inclusion to October the 10th 2016
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Acute cardiovascular hospitalisation due to Myocardial Ischamia
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Cattedra di studio: Torkell Ellingsen, MD, Phd, Odense University Hospital
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie del sistema immunitario
- Malattie autoimmuni
- Malattie articolari
- Malattie muscoloscheletriche
- Malattie reumatiche
- Malattie del tessuto connettivo
- Malattia cardiovascolare
- Artrite
- Artrite, reumatoide
- Effetti fisiologici delle droghe
- Micronutrienti
- Agenti di conservazione della densità ossea
- Ormoni e agenti regolatori del calcio
- Vitamina D
- Colecalciferolo
- Vitamine
- Ergocalciferoli
Altri numeri di identificazione dello studio
- 3-3013-930/1/
Piano per i dati dei singoli partecipanti (IPD)
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