Markers in the Diagnosis of TIA (MIND-TIA)

June 12, 2015 updated by: F.H. Rutten, UMC Utrecht

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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Utrecht, Netherlands, 3508 GA
        • Recruiting
        • Julius Center UMC Utrecht
        • Sub-Investigator:
          • Faas LS Dolmans, MD
        • Principal Investigator:
          • Frans H Rutten, MD, PhD
        • Sub-Investigator:
          • Marie-Louise EL Bartelink, MD, PhD
        • Sub-Investigator:
          • Jaap LJ Kappelle, MD, PhD
        • Sub-Investigator:
          • Arno W Hoes, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

350 patients suspected of TIA by the GP

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients suspected of TIA by the GP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
'Definite' Diagnosis of TIA
Time Frame: After 6 months of follow-up
Determined by expert panel consisting of 3 neurologists
After 6 months of follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ischemic stroke and other cardiovascular events
Time Frame: During 6 months of follow-up
Assessed in the medical records of the GPs
During 6 months of follow-up
Time delay to GP consultation and start of treatment
Time Frame: 1 day of home visit
1 day of home visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UMC Utrecht

Collaborators

Saltro, diagnostic center for primary care.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Anticipated)

March 1, 2016

Study Registration Dates

First Submitted

September 26, 2013

First Submitted That Met QC Criteria

September 30, 2013

First Posted (Estimate)

October 1, 2013

Study Record Updates

Last Update Posted (Estimate)

June 15, 2015

Last Update Submitted That Met QC Criteria

June 12, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL43627.041.13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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