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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Réel)
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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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Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Rheumatoid arthritis patients
Participants in the original, parental trial
|
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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Cardiovascular event
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Acute cardiovascular hospitalisation due to Myocardial Ischamia
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chaise d'étude: Torkell Ellingsen, MD, Phd, Odense University Hospital
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies du système immunitaire
- Maladies auto-immunes
- Maladies articulaires
- Maladies musculo-squelettiques
- Maladies rhumatismales
- Maladies du tissu conjonctif
- Maladies cardiovasculaires
- Arthrite
- Arthrite, rhumatoïde
- Effets physiologiques des médicaments
- Micronutriments
- Agents de conservation de la densité osseuse
- Hormones et agents régulateurs du calcium
- Vitamine D
- Cholécalciférol
- Vitamines
- Ergocalciférols
Autres numéros d'identification d'étude
- 3-3013-930/1/
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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