The main aim of this implementation research is to systematically screen all RA patients of Reade rheumatology and revalidation centre in Amsterdam for their cardiovascular risk profile and if necessary to treat them for cardiovascular risk factors…
ID
Source
Brief title
Condition
- Coronary artery disorders
- Autoimmune disorders
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The percentage of RA patients at baseline, 1, 2, 3, 4 and 5 years,
participating in this implementation study and their assessed risk profile
The calulated difference between 10-years cardiovascular mortality risk at
baseline, 1, 2, 3, 4 and 5 years.
Secondary outcome
First we will assess the cardiovascular risk profile of all participating RA
patients. Then we will calculate the percentages of patients with untreated
hypertension, hypercholesterolemia and/or diabetes mellitus type 2 separately.
The incidence of cardiovascular events, like angina pectoris, myocardial
infarction, ischemic heart disease, heart failure, PCI, CABG, CVA, TIA,
carotid-endarteriectomy, signs of periferal atherosclerosis. We will compare
these incidence rates with the incidence rates of the CARRE study.
The effect of antihypertenive medication and statins in RA patients after 1,
2, 3, 4 and 5 years of CV-RM.
Compliance of lifestyle advices and prescribed medication
Patients satisfaction with offered care, assessed with a questionnaire
Background summary
The risk for fatal and non-fatal cardiovascular disease (CVD) in patients with
rheumatoid arthritis (RA) is doubled in comparison with the general population
and there is accumulating evidence (CARRÉ study) that this enhanced
cardiovascular risk is similar to that of diabetes mellitus (DM), a well known
and established cardiovascular risk factor.
Research has proven that risk factors for CVD, like high cholesterol,
hypertension, smoking, obesity and diabetes are not the only factors
responsible for the higher cardiovascular risk in RA patients. Accumulating
evidence indicates that inflammation plays an important role as atherosclerosis
is in fact an inflammatory disease. Another factor that can play a role is
under treatment of cardiovascular co morbidity in RA, for example there is
accumulating evidence that hypertension is frequently undertreated in RA.
The fact that the cardiovascular risk is higher in patients with RA makes it
necessary to investigate if risk reduction treatment, which has been effective
in other risk groups, is also effective in reducing the cardiovascular risk in
RA patients
Study objective
The main aim of this implementation research is to systematically screen all RA
patients of Reade rheumatology and revalidation centre in Amsterdam for their
cardiovascular risk profile and if necessary to treat them for cardiovascular
risk factors according to the guidelines of Amsterdam: *Cardiovascular Risk
management in Rheumatoid Arthritis (CV-RM)**. We will calculate the 10-years
cardiovascular mortality risk at baseline, 1, 2, 3, 4 and 5 years to see if
this risk reduces through CV-RM implementation.
secondary objectives are: determining undertreatment of cardiovascular risk
factors in RA patients, assessing incidence of cardiovascular disease after
CV-RM implementation and patients compliance and satisfaction with offered care.
*http://www.nvr.nl/uploads/237/144/Amsterdamse_CV-RA_richtlijn_30_mei_2007.pdf
Study design
The primary objective of this project is the implementation of cardiovascular
risk management in rheumatoid arthritis patients. First of all the
cardiovascular risk profile of all rheumatoid arthritis patients of Reade
rheumatology and revalidation centre will be assessed by a nurse practitioner.
Subsequently, we will determine the 10-years cardiovascular mortality risk in a
percentage for all patients using the Systematic Coronary Risk Evaluation
(SCORE)-risk function. Additionally, this risk percentage will be multiplied
with a factor 1.5 to adjust for the higher cardiovascular risk in RA. All
patients will receive lifestyle advice from a nurse practitioner. This means
that the nurse together with the patient will look at the possibilities for
life style changes.
When the calculated 10-years mortality risk is 10% or more treatment with lipid
lowering agents and/or antihypertensives is recommended. These patients will be
referred to the general practitioner for further follow-up and treatment via a
letter or telephone contact.
We will recommend that treatment will be implemented according to the Dutch
Guideline Cardiovascular Risk Management 2006 and this can vary from only
lifestyle recommendations to treatment with lipid lowering drugs and/or
antihypertensives. In all RA patients the cardiovascular risk profile and
10-years cardiovascular risk will again be assessed 1, 2, 3, 4 and 5 years
after the start to see if this has improved. At these moments the patients will
also receive a questionnaire to assess their lifestyle changes, incidence of
cardiovascular disease and the compliance of treatment.
Study burden and risks
The nurse will initiate the screening procedure (assessment of BMI, waist/hip
ratio, blood pressure, DAS28 score, medical history, particularly about
cardiovascular risk factors, an ECG and the necessary laboratory tests
including the lipid profile). With the results the 10-years cardiovascular risk
will be assessed. This will take time and effort of the patients, but this is
for their own health benefit.
The only extra burden is an extra bloodsample taken for research (approximately
50 cc).
Patients with a 10-years CV-risk of more than 10% will be referred to their
general practitioner with the results from the screening and a request for
further cardiovascular risk management. When medication for hypertension or
hypercholesterolemia are prescribed to a patient, this patient has the risk of
side-effects. This can also mean that the patient needs to be checked
periodically, which takes time and effort. But the idea is that this will
ultimately benefit the patients health.
After one and two years all the RA patients will again be invited for
cardiovascular screening by the nurses at Reade revalidation and rheumatology
centre. This time they will also receive a questionnaire about compliance and
quality of life. We will also assess new cardiovascular events. This will be
done to evaluate the effect of this implementation project.
Dokter Jan van Breemenstraat 2
Amsterdam 1056 AB
NL
Dokter Jan van Breemenstraat 2
Amsterdam 1056 AB
NL
Listed location countries
Age
Inclusion criteria
patients who have the diagnosis rheumatoid arthritis according to the ACR classification criteria
Exclusion criteria
no signed informed consent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL34407.048.10 |