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Vitamin D and Cardiovascular Events in Rheumatoid Arthritis

12 października 2016 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Obserwacyjny

Zapisy (Rzeczywisty)

160

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 75 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Metoda próbkowania

Próbka prawdopodobieństwa

Badana populacja

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

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
Rheumatoid arthritis patients
Participants in the original, parental trial
Inny: 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
Inny: 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

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Cardiovascular event
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Acute cardiovascular hospitalisation due to Myocardial Ischamia
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Odense University Hospital

Współpracownicy

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

Śledczy

  • Krzesło do nauki: Torkell Ellingsen, MD, Phd, Odense University Hospital

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 października 1999

Zakończenie podstawowe (Rzeczywisty)

1 października 2016

Ukończenie studiów (Rzeczywisty)

1 października 2016

Daty rejestracji na studia

Pierwszy przesłany

12 października 2016

Pierwszy przesłany, który spełnia kryteria kontroli jakości

12 października 2016

Pierwszy wysłany (Oszacować)

13 października 2016

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

13 października 2016

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

12 października 2016

Ostatnia weryfikacja

1 października 2016

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 3-3013-930/1/

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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