- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02932644
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.
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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.
-
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiovascular event
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acute cardiovascular hospitalisation due to Myocardial Ischamia
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Torkell Ellingsen, MD, Phd, Odense University Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Autoimmune Diseases
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Cardiovascular Diseases
- Arthritis
- Arthritis, Rheumatoid
- Physiological Effects of Drugs
- Micronutrients
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Vitamin D
- Cholecalciferol
- Vitamins
- Ergocalciferols
Other Study ID Numbers
- 3-3013-930/1/
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cardiovascular Disease
-
University of FloridaUniversity of Alabama at Birmingham; Brown UniversityCompletedCardiovascular Disease | Psychosocial Influence on Cardiovascular DiseaseUnited States
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedCardiovascular Disease | Inflammatory DiseaseUnited States
-
Morehouse School of MedicineNot yet recruiting
-
Yonsei UniversityRecruitingCardiovascular DiseaseKorea, Republic of
-
Nanjing Medical UniversityNot yet recruitingCardiovascular Disease
-
National Human Genome Research Institute (NHGRI)Active, not recruiting
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruiting
-
AmgenCompletedCardiovascular DiseaseUnited States, Australia
-
VA Office of Research and DevelopmentEnrolling by invitationCardiovascular DiseaseUnited States
Clinical Trials on Baseline serum vitamin D level below 50 nmol/l
-
Jordan University of Science and TechnologyCompletedVitamin D DeficiencyJordan
-
Assiut UniversityActive, not recruitingVitamin D DeficiencyEgypt
-
Assiut UniversityUnknownInflammatory Bowel Diseases | Vitamin D DeficiencyEgypt
-
Assiut UniversityUnknown
-
Assiut UniversityUnknownLiver Cirrhosis | Vitamin D Deficiency | InfectionEgypt
-
Mansoura UniversityCompleted
-
Ministry of Health, Saudi ArabiaCompletedEarly Childhood Caries, Vitamin D DeficiencySaudi Arabia
-
Hospital Clinic of BarcelonaUnknownObesity | Gastrectomy | Gastric BypassSpain
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedHematopoietic and Lymphoid Cell Neoplasm | Lymphoma | CD20 Positive | Lymphocytic NeoplasmUnited States