To investigate if the detection of B-FABP is possible in the blood of TIA patients (between 6 and 72 hours after the onset of symptoms) and referred by their general practitioner to the outpatient TIA-clinic of the UMC Utrecht or Diakonessenhuis…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Level of B-FABP in the blood of the patiënts
Final diagnosis stated by the neurologist
Secondary outcome
n.v.t.
Background summary
It is difficult to diagnose a patient with a history (and only sometimes signs
and symptoms) suggestive of a minor stroke or transient ischaemic attack (TIA).
No simple diagnostic test with acceptable positive or negative value is
available There is no diagnostic test available. Recent studies underline the
fact that TIA is a medical emergency and adequate targeted treatment of these
patients reduces disability and costs.(1) Urgent treatment of patients
suspected of TIA with existing preventive treatment could reduce the risk of
recurrent stroke by 80-90%.(2) However, many patients are not correctly
diagnosed in primary care.
B-FABP is a relatively new biomarker which could be used in the rapid detection
of brain injury. B-FABP is specific for brain damage and detectable within a
few hours after the event.(4 ) Pelsers et al. showed that B-FABP is detectable
in patients with ischaemic stroke and proved to be useful also for the
detection of minor damage.(4,5)
We are planning a large trial to evaluate the value of a B-FABP blood test in
patients suspected with TIA in addition to clinical findings. In this pilot
study we want to test feasibility of the procedures and to investigate if
B-FABP is detectable in the blood of TIA patients more often than in patients
without TIA.
Study objective
To investigate if the detection of B-FABP is possible in the blood of TIA
patients (between 6 and 72 hours after the onset of symptoms) and referred by
their general practitioner to the outpatient TIA-clinic of the UMC Utrecht or
Diakonessenhuis Utrecht.
Study design
This is a cross sectional pilot study, designed to evaluate B-FABP-values in
the blood of TIA patients. During 3 months we include 50 patients suspected of
a TIA and visiting the outpatient TIA clinic of the UMC Utrecht or
Diakonessenhuis Utrecht. between 6 and 72 hours after onset of symptoms.
Flowchart of the investigation and the TIA clinic diagnostic workup see the
protocol on page 7
With the help of the results, the investigating neurologists will state the
final diagnosis, TIA or no TIA, being the reference test.
For our research, one extra 20 ml tube of blood will be collected and the
patient fills out a questionnaire with some questions about awareness, signs,
symptoms and delay before referral.
Study burden and risks
We will take one extra sample of 20 ml blood from the patients. It might be
necessary to perform an extra venapuncture because of logistic reasons. There
will be no risk for the patient, nor is any physical or psychological
discomfort by participating in this investigation suspected.
Postbus 85 500
3508 GA Utrecht
Nederland
Postbus 85 500
3508 GA Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
Patients with symptoms suspected of TIA lasting less than 24 hours, who arrive at the out-patiënt TIA clinic between 3 and 72 hours from symptom onset.
Exclusion criteria
TIA symptom onset >72 hours.
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 | NL27090.041.09 |