Clinical trial NCT01954329: Markers in the Diagnosis of TIA
Official title: Markers in the Diagnosis of TIA
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Transient Ischemic Attack
Keywords: Biomarkers
TIA
Diagnosis
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: Saltro, diagnostic center for primary care.
First posted: 2013-10-01
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 350 patients suspected of TIA by the GP

Brief summary: MIND-TIA is primarily an observational diagnostic study that aims to evaluate the role of novel biomarkers in the diagnosis of Transient Ischemic Attack (TIA)in primary care.

Rapid and adequate diagnosis of TIA is of great importance to enable a rapid start of treatment, and thereby decrease the risk of subsequent ischemic stroke.

Detailed description: Rationale:

A Transient Ischaemic Attack (TIA) does not cause permanent damage of brain tissue, but the risk of a subsequent ischemic stroke in the short term is high. Timely recognition of TIA would result in early treatment and reduce the risk of ischaemic stroke, and other adverse cardiovascular events.

To improve the management of TIA adequate diagnosis is of imminent importance. However the diagnosis is notoriously difficult, for both GP and neurologist.

Adequate biomarkers for brain ischaemia could improve the early diagnosis and thus the subsequent management of TIA.

Objectives:

1. To assess the added diagnostic value of biomarkers beyond the clinical assessment (medical history, signs and symptoms) in patients suspected of TIA.

   Secondary objectives
2. To assess the prognostic value of biomarkers in patients with an established diagnosis of TIA.
3. To assess the time delay and factors related to delay in patients suspected of TIA.

Study population:

350 adult persons suspected of TIA from primary care.

Methods:

Recruitment of patients will be performed at the general practices of 200 GPs in the vicinity of 4 to 5 participating hospitals. During a home visit a research nurse collects a blood sample, and takes two health-related questionnaires. Participants will be referred by their GP to the regional TIA outpatient clinic for additional investigations, including brain imaging. The diagnostic accuracy of a set of biomarkers will be assessed with the 'definite' diagnosis of TIA by a panel of neurologists as the reference standard.

Eligibility criteria: 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

Primary outcomes:
measure: 'Definite' Diagnosis of TIA
timeFrame: After 6 months of follow-up
Secondary outcomes:
measure: Ischemic stroke and other cardiovascular events
timeFrame: During 6 months of follow-up
measure: Time delay to GP consultation and start of treatment
timeFrame: 1 day of home visit
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: Julius Center UMC Utrecht
Study officials:
References:
citation: Dolmans LS, Rutten F, Bartelink MEL, van Dijk EJ, Nederkoorn PJ, Kappelle J, Hoes AW; MIND-TIA study group. Serum biomarkers in patients suspected of transient ischaemic attack in primary care: a diagnostic accuracy study. BMJ Open. 2019 Oct 17;9(10):e031774. doi: 10.1136/bmjopen-2019-031774.
citation: Dolmans LS, Rutten FH, El Bartelink ML, Seppenwoolde G, van Delft S, Kappelle LJ, Hoes AW. Serum biomarkers for the early diagnosis of TIA: The MIND-TIA study protocol. BMC Neurol. 2015 Jul 28;15:119. doi: 10.1186/s12883-015-0388-z.