Markers in the Diagnosis of TIA (MIND-TIA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by UMC Utrecht
Sponsor:
Collaborator:
Saltro, diagnostic center for primary care.
Information provided by (Responsible Party):
F.H. Rutten, UMC Utrecht
ClinicalTrials.gov Identifier:
NCT01954329
First received: September 26, 2013
Last updated: September 30, 2013
Last verified: September 2013

September 26, 2013
September 30, 2013
September 2013
March 2016   (final data collection date for primary outcome measure)
'Definite' Diagnosis of TIA [ Time Frame: After 6 months of follow-up ] [ Designated as safety issue: No ]
Determined by expert panel consisting of 3 neurologists
Same as current
Complete list of historical versions of study NCT01954329 on ClinicalTrials.gov Archive Site
  • Ischemic stroke and other cardiovascular events [ Time Frame: During 6 months of follow-up ] [ Designated as safety issue: No ]
    Assessed in the medical records of the GPs
  • Time delay to GP consultation and start of treatment [ Time Frame: 1 day of home visit ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Markers in the Diagnosis of TIA
Not Provided

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:

Serum, RNA and DNA material.

Non-Probability Sample

350 patients suspected of TIA by the GP

Transient Ischemic Attack
Not Provided
Patients suspected of TIA by the GP
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
350
Not Provided
March 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Louis Servaas Dolmans, MD +31-88-7568159 L.S.Dolmans@umcutrecht.nl
Netherlands
 
NCT01954329
NL43627.041.13
Yes
F.H. Rutten, UMC Utrecht
UMC Utrecht
Saltro, diagnostic center for primary care.
Not Provided
UMC Utrecht
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP