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Markers in the Diagnosis of TIA (MIND-TIA)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2015 by F.H. Rutten, UMC Utrecht.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01954329
First Posted: October 1, 2013
Last Update Posted: June 15, 2015
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.
Collaborator:
Saltro, diagnostic center for primary care.
Information provided by (Responsible Party):
F.H. Rutten, UMC Utrecht
  Purpose

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.


Condition
Transient Ischemic Attack

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Markers in the Diagnosis of TIA

Resource links provided by NLM:


Further study details as provided by F.H. Rutten, UMC Utrecht:

Primary Outcome Measures:
  • 'Definite' Diagnosis of TIA [ Time Frame: After 6 months of follow-up ]
    Determined by expert panel consisting of 3 neurologists


Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA
Serum, RNA and DNA material.

Estimated Enrollment: 350
Study Start Date: September 2013
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients suspected of TIA by the GP

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
350 patients suspected of TIA by the GP
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01954329


Contacts
Contact: Louis Servaas Dolmans, MD +31-88-7568159 L.S.Dolmans@umcutrecht.nl

Locations
Netherlands
Julius Center UMC Utrecht Recruiting
Utrecht, Netherlands, 3508 GA
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         
Sponsors and Collaborators
UMC Utrecht
Saltro, diagnostic center for primary care.
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: F.H. Rutten, MD, PhD, UMC Utrecht
ClinicalTrials.gov Identifier: NCT01954329     History of Changes
Other Study ID Numbers: NL43627.041.13
First Submitted: September 26, 2013
First Posted: October 1, 2013
Last Update Posted: June 15, 2015
Last Verified: June 2015

Keywords provided by F.H. Rutten, UMC Utrecht:
Biomarkers
TIA
Diagnosis

Additional relevant MeSH terms:
Ischemic Attack, Transient
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases