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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (실제)
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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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공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Cardiovascular event
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Acute cardiovascular hospitalisation due to Myocardial Ischamia
기간: 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
|
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Acute cardiovascular hospitalisation due to hearth failure
기간: Observed in the time-period from inclusion to October the 10th 2016
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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
|
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Acute cardiovascular hospitalisation due to stroke
기간: Observed in the time-period from inclusion to October the 10th 2016
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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
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Observed in the time-period from inclusion to October the 10th 2016
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Acute cardiovascular hospitalisation due to arrhythmias
기간: 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
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Observed in the time-period from inclusion to October the 10th 2016
|
|
Acute cardiovascular hospitalisation due to Procedure-related cardiovascular event
기간: Observed in the time-period from inclusion to October the 10th 2016
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Any cardiovascular event within 24 hours after cardiovascular medical examination/procedure/surgery.
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Observed in the time-period from inclusion to October the 10th 2016
|
|
Acute cardiovascular hospitalisation due to other reasons
기간: 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.
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Observed in the time-period from inclusion to October the 10th 2016
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Acute cardiovascular hospitalisation due to supposed cardiovascular reason
기간: 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
기간: Observed in the time-period from inclusion to October the 10th 2016
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Acute hospitalisation due to cancer
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Observed in the time-period from inclusion to October the 10th 2016
|
|
Acute non-cardiovascular hospitalisation due to infection
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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 other cardiovascular reasons
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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Witnessed, sudden cardiovascular death
기간: Observed in the time-period from inclusion to October the 10th 2016
|
Death is witnessed and abrupt within one hour after symptom-onset
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Observed in the time-period from inclusion to October the 10th 2016
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Non-witnessed, sudden cardiovascular death
기간: Observed in the time-period from inclusion to October the 10th 2016
|
Non-witnessed death with no obvious non-cardiovascular reasons (found death)
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Observed in the time-period from inclusion to October the 10th 2016
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Non-sudden cardiovascular death
기간: Observed in the time-period from inclusion to October the 10th 2016
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Death due to any of the cardiovascular caused previously mentioned, more than one hour after symptom-onset
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Observed in the time-period from inclusion to October the 10th 2016
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공동 작업자 및 조사자
협력자
수사관
- 연구 의자: Torkell Ellingsen, MD, Phd, Odense University Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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