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Rheumatoid ArthritisNCT02932644

Vitamin D and Cardiovascular Events in Rheumatoid Arthritis

An observational study of Rheumatoid Arthritis and Cardiovascular Disease, run by Odense University Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Rheumatoid Arthritis, Cardiovascular Disease
What is being tested?
Baseline serum vitamin D level below 50 nmol/l and Baseline serum vitamin D level at or above 50 nmol/l
How many people
160 participants
Where
No sites listed yet
Study dates
Oct 1999to Oct 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

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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About this study

Official title: 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.

Read the 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.

Being tested
Baseline serum vitamin D level below 50 nmol/l, Baseline serum vitamin D level at or above 50 nmol/l
Keywords
Rheumatoid Arthritis, Cardiovascular event, Cardiovascular mortality, Vitamin D
Medical subject headings
Arthritis, Rheumatoid, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Baseline serum vitamin D level below 50 nmol/lOther

    There is no medical intervention. The two groups are simple allocated depending on serum levels of D-total at the time of diagnosis

  • Baseline serum vitamin D level at or above 50 nmol/lOther

    There is no medical intervention. The two groups are simple allocated depending on serum levels of D-total at the time of diagnosis

Study groups in NCT02932644
Study groupRoleWhat they receive
Rheumatoid arthritis patientsParticipants in the original, parental trial
Receives: Other: Baseline serum vitamin D level below 50 nmol/l; Other: Baseline serum vitamin D level at or above 50 nmol/l

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cardiovascular event

    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"

    Measured: Observed in the time-period from inclusion to October the 10th 2016

Secondary outcomes (25)

  1. Acute cardiovascular hospitalisation due to Myocardial Ischamia

    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).

    Measured: Observed in the time-period from inclusion to October the 10th 2016

  2. Acute cardiovascular hospitalisation due to hearth failure

    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.

    Measured: Observed in the time-period from inclusion to October the 10th 2016

  3. Acute cardiovascular hospitalisation due to stroke

    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

    Measured: Observed in the time-period from inclusion to October the 10th 2016

  4. Acute cardiovascular hospitalisation due to arrhythmias

    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

    Measured: Observed in the time-period from inclusion to October the 10th 2016

  5. Acute cardiovascular hospitalisation due to Procedure-related cardiovascular event

    Any cardiovascular event within 24 hours after cardiovascular medical examination/procedure/surgery.

    Measured: Observed in the time-period from inclusion to October the 10th 2016

  6. Acute cardiovascular hospitalisation due to other reasons

    Hospitalisation caused by other cardiovascular events, e.g. pulmonary embolism, rupture of aortic aneurism etc.

    Measured: Observed in the time-period from inclusion to October the 10th 2016

  7. Acute cardiovascular hospitalisation due to supposed cardiovascular reason

    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

    Measured: Observed in the time-period from inclusion to October the 10th 2016

  8. Acute non-cardiovascular hospitalisation due to cancer

    Acute hospitalisation due to cancer

    Measured: Observed in the time-period from inclusion to October the 10th 2016

  9. Acute non-cardiovascular hospitalisation due to infection

    Acute hospitalisation due to infection

    Measured: Observed in the time-period from inclusion to October the 10th 2016

  10. Acute non-cardiovascular hospitalisation due to respiratory disease

    Acute hospitalisation due to respiratory disease

    Measured: Observed in the time-period from inclusion to October the 10th 2016

  11. Acute non-cardiovascular hospitalisation due to trauma

    Acute hospitalisation due to trauma

    Measured: Observed in the time-period from inclusion to October the 10th 2016

  12. Acute non-cardiovascular hospitalisation due to suicide

    Acute - hospitalisation due to suicide

    Measured: Observed in the time-period from inclusion to October the 10th 2016

  13. Acute non-cardiovascular hospitalisation due to other reasons

    Acute hospitalisation du to other non-cardiovascular reasons, than those previous mentioned

    Measured: Observed in the time-period from inclusion to October the 10th 2016

  14. Elective cardiovascular hospitalisation due to myocardial ischemia

    Measured: Observed in the time-period from inclusion to October the 10th 2016

  15. Elective cardiovascular hospitalisation due to arrhythmia

    Measured: Observed in the time-period from inclusion to October the 10th 2016

  16. Elective cardiovascular hospitalisation due to heart failure

    Measured: Observed in the time-period from inclusion to October the 10th 2016

  17. Elective cardiovascular hospitalisation due to other cardiovascular reasons

    Measured: Observed in the time-period from inclusion to October the 10th 2016

  18. Elective non-cardiovascular hospitalisation due to cancer

    Measured: Observed in the time-period from inclusion to October the 10th 2016

  19. Elective non-cardiovascular hospitalisation due to infection

    Measured: Observed in the time-period from inclusion to October the 10th 2016

  20. Elective non-cardiovascular hospitalisation due to respiratory disease

    Measured: Observed in the time-period from inclusion to October the 10th 2016

  21. Elective non-cardiovascular hospitalisation due to trauma

    Measured: Observed in the time-period from inclusion to October the 10th 2016

  22. Elective non-cardiovascular hospitalisation due to suicide

    Measured: Observed in the time-period from inclusion to October the 10th 2016

  23. Witnessed, sudden cardiovascular death

    Death is witnessed and abrupt within one hour after symptom-onset

    Measured: Observed in the time-period from inclusion to October the 10th 2016

  24. Non-witnessed, sudden cardiovascular death

    Non-witnessed death with no obvious non-cardiovascular reasons (found death)

    Measured: Observed in the time-period from inclusion to October the 10th 2016

  25. Non-sudden cardiovascular death

    Death due to any of the cardiovascular caused previously mentioned, more than one hour after symptom-onset

    Measured: Observed in the time-period from inclusion to October the 10th 2016

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2016 (estimated)
  2. Study startOct 1999
  3. Primary completionOct 2016
  4. Study completionOct 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02932644
Sponsor's protocol ID
3-3013-930/1/
Status last verified
Oct 2016
First submitted
12 Oct 2016
Last updated
13 Oct 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Rheumatoid Arthritis and Cardiovascular Disease, run by Odense University Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardiovascular event (time frame: Observed in the time-period from inclusion to October the 10th 2016). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02932644.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2016.

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