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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (実際)
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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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研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Cardiovascular event
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Acute cardiovascular hospitalisation due to Myocardial Ischamia
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Observed in the time-period from inclusion to October the 10th 2016
|
Observed in the time-period from inclusion to October the 10th 2016
|
|
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Elective cardiovascular hospitalisation due to arrhythmia
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
協力者
捜査官
- スタディチェア：Torkell Ellingsen, MD, Phd、Odense University Hospital
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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