NCT01954329

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

September 26, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 1, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Last Updated

June 15, 2015

Status Verified

June 1, 2015

Enrollment Period

2.5 years

First QC Date

September 26, 2013

Last Update Submit

June 12, 2015

Conditions

Keywords

BiomarkersTIADiagnosis

Outcome Measures

Primary Outcomes (1)

  • 'Definite' Diagnosis of TIA

    Determined by expert panel consisting of 3 neurologists

    After 6 months of follow-up

Secondary Outcomes (2)

  • Ischemic stroke and other cardiovascular events

    During 6 months of follow-up

  • Time delay to GP consultation and start of treatment

    1 day of home visit

Study Arms (1)

Patients suspected of TIA by the GP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

350 patients suspected of TIA by the GP

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Julius Center UMC Utrecht

Utrecht, Utrecht, 3508 GA, Netherlands

RECRUITING

Related Publications (2)

  • 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.

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Serum, RNA and DNA material.

MeSH Terms

Conditions

Ischemic Attack, TransientDisease

Condition Hierarchy (Ancestors)

Brain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Louis Servaas Dolmans, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

September 26, 2013

First Posted

October 1, 2013

Study Start

September 1, 2013

Primary Completion

March 1, 2016

Last Updated

June 15, 2015

Record last verified: 2015-06

Locations