Markers in the Diagnosis of TIA (MIND-TIA)

• ClinicalTrials.gov Identifier: NCT01954329
• Recruitment Status: Unknown
• First Posted: October 1, 2013
• Last Update Posted: June 15, 2015
• Sponsor: UMC Utrecht
• 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

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 *

• Dolmans LS, Rutten F, Bartelink MEL, van Dijk EJ, Nederkoorn PJ, Kappelle J, Hoes AW; MIND-TIA study group. Serum biomarkers in patients suspected of transient ischaemic attack in primary care: a diagnostic accuracy study. BMJ Open. 2019 Oct 17;9(10):e031774. doi: 10.1136/bmjopen-2019-031774.
• Dolmans LS, Rutten FH, El Bartelink ML, Seppenwoolde G, van Delft S, Kappelle LJ, Hoes AW. Serum biomarkers for the early diagnosis of TIA: The MIND-TIA study protocol. BMC Neurol. 2015 Jul 28;15:119. doi: 10.1186/s12883-015-0388-z.

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

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