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Vitamin D and Cardiovascular Events in Rheumatoid Arthritis

12 октября 2016 г. обновлено: 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.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Подробное описание

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.

Тип исследования

Наблюдательный

Регистрация (Действительный)

160

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 18 лет до 75 лет (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Метод выборки

Вероятностная выборка

Исследуемая популяция

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

Описание

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.

-

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

Когорты и вмешательства

Группа / когорта
Вмешательство/лечение
Rheumatoid arthritis patients
Participants in the original, parental trial
Другой: 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
Другой: 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

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Cardiovascular event
Временное ограничение: 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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Acute cardiovascular hospitalisation due to Myocardial Ischamia
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Odense University Hospital

Соавторы

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

Следователи

  • Учебный стул: Torkell Ellingsen, MD, Phd, Odense University Hospital

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования

1 октября 1999 г.

Первичное завершение (Действительный)

1 октября 2016 г.

Завершение исследования (Действительный)

1 октября 2016 г.

Даты регистрации исследования

Первый отправленный

12 октября 2016 г.

Впервые представлено, что соответствует критериям контроля качества

12 октября 2016 г.

Первый опубликованный (Оценивать)

13 октября 2016 г.

Обновления учебных записей

Последнее опубликованное обновление (Оценивать)

13 октября 2016 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

12 октября 2016 г.

Последняя проверка

1 октября 2016 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • 3-3013-930/1/

Планирование данных отдельных участников (IPD)

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НЕ РЕШЕНО

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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