The main objective of this study is to determine if the SPC has added benefits in optimising risk factors to prevent recurrent stroke, as compared with secondary prevention performed by the GP.
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is a composite score on a newly proposed
stroke-prevention-scale. This composite score will be calculated based on the
presence or absence of the risk factors and the established relative risk (RR)
as published in the literature.
Secondary outcome
1. Stroke caused by subarachnoidal haemorrhage or cerebral venous sinus
thrombosis
2. Dissection of the carotid artery (these patients have no cardiovascular risk
factors for stroke recurrence)
3. No informed consent obtained
Background summary
Stroke is the main cause of disability in high-income countries and ranks
second as cause of death worldwide. Recurrent stroke occurs in about 26% of the
patients within 5 years. It is therefore crucial to pay attention to minimizing
the risk of recurrence. Several risk factors for recurrent stroke can be
directly influenced: smoking, hypertension, hypercholesterolemia and diabetes.
Treatment of these modifiable risk factors has been shown to reduce the risk of
stroke and is known as *secondary prevention*.
To date, in routine clinical practice, the general practitioner (GP) takes care
of secondary prevention. However, the degree to which secondary prevention is
practiced depends on the dedication of the GP and the compliance of patients,
is not standardised and might have considerable variability between different
GP*s. In order to standardise the secondary prevention and possibly improve
treatment of previous mentioned risk factors, the Department of Neurology at
the Academic Medical Center (AMC) has recently started a specific outpatient
clinic, known as the *secondary prevention clinic* (SPC), as a clinical
routine. The present study will investigate if the initiation of this SPC has
larger effects on reducing the risk factors of stroke, as compared with
secondary prevention performed by the GP. When results of the present study
(phase I) show in superior treatment of risk factors, a randomised trial to
investigate the effect of SPC on clinical outcomes (recurrent stroke) will be
planned in the near future (phase II).
Study objective
The main objective of this study is to determine if the SPC has added benefits
in optimising risk factors to prevent recurrent stroke, as compared with
secondary prevention performed by the GP.
Study design
We will conduct a prospective sequential comparison study. Consecutive patients
treated with the SPC protocol will be compared with historical controls:
patients treated with *standard care* by the GP, as was considered *usual care*
before initiation of the SPC.
Intervention
Standardized, regular check ups during one year after the initial event,
performed at the SPC in our outpatient neurology department.
Study burden and risks
Main goal of the SPC is to reduce the number of stroke recurrences through
regular monitoring of the lifestyle of a patient who has suffered a stroke, in
an active and standardized way. Since February 2011, all consecutive stroke
patients in our department are referred to the SPC when *regular follow-up* in
the acute phase of a stroke has been completed. For patients *regular
follow-up* comprises of a possible hospital admission, initiation of treatment
for stroke, and a single follow-up visit to a neurologist at the outpatient
clinic two weeks after the initial event.
At the SPC, a blood sample will be taken to (re)evaluate fasting glucose and
cholesterol. In addition, patients will be asked to fill in a questionnaire to
gain insight in a patient*s lifestyle, and the blood pressure will be measured
during 30 minutes (Dynamap). After the intake and assessment of the personal
risk profile of a patient, a *risk reduction plan* will be made in consultation
with the patient. Patients will be followed for one year to actively encourage
them to work on their risk plan and to set up new goals.
The *personal risk profile* will also be made for the patients from the control
group. In the single visit to the SPC, one year after the stroke, the same
procedures will take place to assess the personal cardiovascular risk profile,
as will be performed in stroke patients nowadays.
Meibergdreef 9
1100 DD Amsterdam
NL
Meibergdreef 9
1100 DD Amsterdam
NL
Listed location countries
Age
Inclusion criteria
1. Age at least 18 years
2. Stroke (ischemic or haemorrhagic)
3. Visitor of the AMC outpatient clinic
Exclusion criteria
1. Stroke caused by subarachnoidal haemorrhage or cerebral venous sinus thrombosis
2. Dissection of the carotid artery (these patients have no cardiovascular risk factors for stroke recurrence)
3. No informed consent obtained
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 | NL38035.018.11 |