Transient Ischemic AttackMIND-TIANCT01954329
Markers in the Diagnosis of TIA
An observational study of Transient Ischemic Attack, run by UMC Utrecht at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transient Ischemic Attack
- How many people
- 350 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2013to Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 350 patients suspected of TIA by the GP
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Julius Center UMC Utrecht
Utrecht, Utrecht, 3508 GA
Faas LS Dolmans, MD
Frans H Rutten, MD, PhD
About this study
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.
Read the 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:
- To assess the added diagnostic value of biomarkers beyond the clinical assessment (medical history, signs and symptoms) in patients suspected of TIA. Secondary objectives
- To assess the prognostic value of biomarkers in patients with an established diagnosis of TIA.
- 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.
- Conditions
- Transient Ischemic Attack
- Keywords
- Biomarkers, TIA, Diagnosis
- Medical subject headings
- Ischemic Attack, Transient, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients suspected of TIA by the GP | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
'Definite' Diagnosis of TIA
Determined by expert panel consisting of 3 neurologists
Measured: After 6 months of follow-up
Secondary outcomes (2)
Ischemic stroke and other cardiovascular events
Assessed in the medical records of the GPs
Measured: During 6 months of follow-up
Time delay to GP consultation and start of treatment
Measured: 1 day of home visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2013 (estimated)
- Study startSep 2013
- Primary completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Transient Ischemic AttackStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Saltro, diagnostic center for primary care.
- Responsible party
- Principal investigator, F.H. Rutten, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01954329
- Sponsor's protocol ID
- NL43627.041.13
- Acronym
- MIND-TIA
- Status last verified
- Jun 2015
- First submitted
- 26 Sep 2013
- Last updated
- 15 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 31628130Dolmans 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.
PubMed 26215720
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Markers in the Diagnosis of TIA
- ClinicalTrials.gov ID
- NCT01954329
- Acronym / sponsor ID
- MIND-TIA / NL43627.041.13
- Conditions
- Transient Ischemic Attack
- Keywords
- Biomarkers, TIA, Diagnosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Saltro, diagnostic center for primary care.
- Study start
- Sep 2013
- Primary completion
- Mar 2016 (estimated)
- First posted
- 1 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To assess the added diagnostic value of biomarkers beyond the clinical assessment (medical history, signs and symptoms) in patients suspected of TIA. Secondary objectives
- To assess the prognostic value of biomarkers in patients with an established diagnosis of TIA.
- 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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients suspected of TIA by the GP | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 350 patients suspected of TIA by the GP
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
'Definite' Diagnosis of TIA
Time frame: After 6 months of follow-up
Determined by expert panel consisting of 3 neurologists
2 secondary outcomes
Ischemic stroke and other cardiovascular events
Time frame: During 6 months of follow-up
Time delay to GP consultation and start of treatment
Time frame: 1 day of home visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2015.
- Derived from this study: PubMed 31628130Dolmans 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.
- Derived from this study: PubMed 26215720Dolmans 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.
- Dutch study websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transient Ischemic Attack, run by UMC Utrecht at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Louis Servaas Dolmans, MD (+31-88-7568159, L.S.Dolmans@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
'Definite' Diagnosis of TIA (time frame: After 6 months of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01954329, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2015.