Markers in the Diagnosis of TIA

Transient Ischemic Attack Clinical Trial

— MIND-TIA  

Official title:

Markers in the Diagnosis of TIA

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01954329
• Other study ID #: NL43627.041.13
• Status: Recruiting
• Phase: N/A
• First received: September 26, 2013
• Last updated: June 12, 2015
• Start date: September 2013

Study information

• Verified date: June 2015
• Source: UMC Utrecht
• Contact: Louis Servaas Dolmans, MD
• Phone: +31-88-7568159
• Email: L.S.Dolmans[@]umcutrecht.nl
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Ischemic Attack, Transient
• Transient Ischemic Attack

Locations

Country	Name	City	State
Netherlands	Julius Center UMC Utrecht	Utrecht

Sponsors (2)

Lead Sponsor	Collaborator
UMC Utrecht	Saltro, diagnostic center for primary care.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	'Definite' Diagnosis of TIA	Determined by expert panel consisting of 3 neurologists	After 6 months of follow-up	No
Secondary	Ischemic stroke and other cardiovascular events	Assessed in the medical records of the GPs	During 6 months of follow-up	No
Secondary	Time delay to GP consultation and start of treatment		1 day of home visit	No

External Links

•   Dutch study website