NCT02932644

Brief 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 low levels of vitamin D can be part of a prediction model for cardiovascular disease in Rheumatoid Arthritis.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 1999

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1999

Completed
17 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

October 12, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 13, 2016

Completed
Last Updated

October 13, 2016

Status Verified

October 1, 2016

Enrollment Period

17 years

First QC Date

October 12, 2016

Last Update Submit

October 12, 2016

Conditions

Rheumatoid ArthritisCardiovascular Disease

Keywords

Rheumatoid ArthritisCardiovascular eventCardiovascular mortalityVitamin D

Outcome Measures

Primary Outcomes (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"

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

Secondary Outcomes (25)

  • Acute cardiovascular hospitalisation due to Myocardial Ischamia

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

  • Acute cardiovascular hospitalisation due to hearth failure

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

  • Acute cardiovascular hospitalisation due to stroke

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

  • Acute cardiovascular hospitalisation due to arrhythmias

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

  • Acute cardiovascular hospitalisation due to Procedure-related cardiovascular event

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

  • +20 more secondary outcomes

Study Arms (1)

Rheumatoid arthritis patients

Participants in the original, parental trial

Other: Baseline serum vitamin D level below 50 nmol/lOther: Baseline serum vitamin D level at or above 50 nmol/l

Interventions

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

Rheumatoid arthritis patients
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

Rheumatoid arthritis patients

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Arthritis, RheumatoidCardiovascular Diseases

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Torkell Ellingsen, MD, Phd

    Odense University Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 12, 2016

First Posted

October 13, 2016

Study Start

October 1, 1999

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

October 13, 2016

Record last verified: 2016-10