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Markers in the Diagnosis of TIA (MIND-TIA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01954329
Recruitment Status : Unknown
Verified June 2015 by F.H. Rutten, UMC Utrecht.
Recruitment status was:  Recruiting
First Posted : October 1, 2013
Last Update Posted : June 15, 2015
Sponsor:
Collaborator:
Saltro, diagnostic center for primary care.
Information provided by (Responsible Party):
F.H. Rutten, UMC Utrecht

Tracking Information
First Submitted Date September 26, 2013
First Posted Date October 1, 2013
Last Update Posted Date June 15, 2015
Study Start Date September 2013
Estimated Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 30, 2013)
'Definite' Diagnosis of TIA [ Time Frame: After 6 months of follow-up ]
Determined by expert panel consisting of 3 neurologists
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 30, 2013)
  • Ischemic stroke and other cardiovascular events [ Time Frame: During 6 months of follow-up ]
    Assessed in the medical records of the GPs
  • Time delay to GP consultation and start of treatment [ Time Frame: 1 day of home visit ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Markers in the Diagnosis of TIA
Official Title Markers in the Diagnosis of TIA
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Serum, RNA and DNA material.
Sampling Method Non-Probability Sample
Study Population 350 patients suspected of TIA by the GP
Condition Transient Ischemic Attack
Intervention Not Provided
Study Groups/Cohorts Patients suspected of TIA by the GP
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: September 30, 2013)
350
Original Estimated Enrollment Same as current
Study Completion Date Not Provided
Estimated Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT01954329
Other Study ID Numbers NL43627.041.13
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party F.H. Rutten, UMC Utrecht
Study Sponsor UMC Utrecht
Collaborators Saltro, diagnostic center for primary care.
Investigators Not Provided
PRS Account UMC Utrecht
Verification Date June 2015