The main objective is to assess the added diagnostic value of biomarker assessment beyond the clinical assessment in patients suspected of TIA in primary care. Secondary objectives are i) to assess the prognostic value of biomarker assessment in…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the level of a set of biomarkers in a venous blood
sample taken within 72 hours after onset of symptoms. Main study endpoint is
the definite diagnosis of TIA (reference standard), which will be established
by an expert panel consisting of three neurologists using all available
diagnostic information including imaging of the brain and 6 months of
follow-up.
Secondary outcome
Secondary parameters:
Possible factors influencing doctor*s and patient*s delay
Secondary endpoints:
- Endpoints during 6months of follow-up: (ischemic) cerebrovascular events,
(ischemic) cardiovascular events, and mortality.
- Time delay (f.e. time to first of action of the patient, time to GP
consultation)
Background summary
With Transient Ischaemic Attack (TIA) there is no permanent damage of brain
tissue by definition, but the risk of a subsequent ischemic stroke is
significant, especially within the first 2 weeks. In addition, the risk of
other cardiovascular events is increased in these patients. Timely recognition
of TIA to enable urgent treatment to prevent subsequent events is of imminent
importance. However, establishing or excluding the diagnosis can be notoriously
difficult for several reasons, especially in the primary care setting. A
possible solution to the diagnostic difficulties in TIA could be a serum
biomarker for brain ischemia. A more rapid and more accurate diagnosis would
enable more appropriate treatment and thereby result in a better prognosis.
Study objective
The main objective is to assess the added diagnostic value of biomarker
assessment beyond the clinical assessment in patients suspected of TIA in
primary care.
Secondary objectives are i) to assess the prognostic value of biomarker
assessment in patients with TIA, and ii) to assess the time delay from symptoms
to treatment, and iii) evaluate patient characteristics and other factors that
are related to delay in patients suspected of TIA.
Study design
Diagnostic accuracy study with 6 months of follow-up.
Study burden and risks
The study protocol follows the routine care for TIA patients and does not
interfere with common diagnostic or therapeutic decisions. The main extra
burden for participants is a venepuncture for drawing a small extra sample of
blood (20 ml) for biomarker assessment. This will be performed by a research
nurse during a home visit as soon as possible after the GP consultation.
Participants also have to fill out two health-related questionnaires.
Except for the minor complications of a venepuncture there are no extra risks
for the participants in this study. The potential benefits of our study for
future patients suspected of TIA and related medical care can be substantial.
Primarily and ideally we hope to find biomarkers that will enable a more rapid
and accurate diagnosis of TIA and thus will result in a more appropriate and
timely treatment and an improved prognosis in these patients.
Universiteitsweg 100
Utrecht 3584 CG
NL
Universiteitsweg 100
Utrecht 3584 CG
NL
Listed location countries
Age
Inclusion criteria
* Being adult (18 years and older)
* Presenting to the GP with a new episode of symptoms suspected of TIA and the GP considering further investigations to confirm or exclude TIA at the TIA outpatient clinic.
* A blood sample can be collected within 72 hours after onset of symptoms.
Exclusion criteria
* The patient still has active symptoms or signs suspected of an ongoing ischemic stroke and immediate referral to the neurologist seems indicated.
* Valid history taking is impossible because of severe cognitive impairment or insufficient knowledge of the Dutch language.
* Patient with a life expectancy of < 6 months.
* Patient is not willing or able to give written 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 | NL43627.041.13 |