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
  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

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • '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


Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: F.H. Rutten, MD, PhD, UMC Utrecht
ClinicalTrials.gov Identifier: NCT01954329     History of Changes
Other Study ID Numbers: NL43627.041.13
Study First Received: September 26, 2013
Last Updated: September 30, 2013
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by 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

ClinicalTrials.gov processed this record on July 28, 2014