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Ischemic Attack, TransientMIDNOR-TIANCT02038725

MIDNOR-TIA - a Study of 600 Patients With Transient Ischemic Attack

An observational study of Ischemic Attack, Transient and Stroke, run by Norwegian University of Science and Technology at 8 sites in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Patients with a transient ischemic attack (TIA) are at high risk of stroke. Rapid assessment and treatment can reduce the risk. Several international guidelines recommend a test, the ABCD2 score, to identify TIA patients with low and high risk for stroke. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Ischemic Attack, Transient, Stroke
How many people
584 participants
Where
8 sitesNorway
Study dates
Oct 2012to Jul 2015
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 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients referred to a hospital in Central Norway with a recent probable or possible transient ischemic attack

Who may be able to join

  • Probable or possible transient ischemic attack
  • Residing in Central Norway
  • Examined within 2 weeks after the onset of symptoms
  • Modified Rankin Scale 3 or less and living at home
  • Informed consent

Who cannot join

None listed.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Norway8 sites

  • Ålesund Sykehus

    Ålesund

  • Kristiansund Sykehus

    Kristiansund

  • Levanger Sykehus

    Levanger

  • Molde Sykehus

    Molde

  • Namsos Sykehus

    Namsos

  • Orkdal Sykehus

    Orkanger

  • St Olavs Hospital

    Trondheim

  • Volda Sykehus

    Volda

Other trials in Norway

About this study

Official title: MIDNOR-TIA - a Prospective Cohort Study of 600 TIA Patients in Central Norway

Patients with a transient ischemic attack (TIA) are at high risk of stroke. Rapid assessment and treatment can reduce the risk. Several international guidelines recommend a test, the ABCD2 score, to identify TIA patients with low and high risk for stroke. The main purpose of this study is to investigate stroke risk after TIA in both short (1 week) and long term (3 months/1 year), and to assess whether the ABCD2 score ('Age, blood pressure, clinical features, duration of TIA, diabetes score) is an adequate tool for predicting stroke risk. Secondary aims are to explore whether adopting imaging modalities (ultrasound, MRI) and biological markers of blood into a risk score could improve the predictive value of the ABCD2 score and still be feasible in a daily clinical practice. Further on overall risk factors in TIA patients, and the incidence of other vascular events will be studied. A substudy designed as a randomised controlled trial evaluates pharmaceutical counseling in a subset of participants. Cost-benefit analysis, and a long-term follow-up (5 years) is planned.

Keywords
Risks, Risk Factors, ABCD2 score, Predictive Value of Tests, Risk Assessment, Severity of Illness Index, Decision Support Techniques
Medical subject headings
Ischemic Attack, Transient, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02038725
Study groupRoleWhat they receive
TIA in last 2 weeksNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients presenting with stroke within 1 week after transient ischemic attack

    Measured by using data from the Norwegian Stroke Registry

    Measured: 1 week

Secondary outcomes (9)

  1. Number of patients presenting with stroke within 3 months after transient ischemic attack

    Measured by using data from the Norwegian Stroke Registry

    Measured: 3 months

  2. Correlation between the ABCD2 score and the incidence of stroke within 1 week after transient ischemic attack

    Measured by comparing the ABCD2 score and the incidence of stroke within 1 week after transient ischemic attack based on data from the Norwegian Stroke Registry

    Measured: 1 week

  3. Correlation between the ABCD2 score and the incidence of stroke within 3 months after transient ischemic attack

    Measured by comparing the ABCD2 score and the incidence of stroke within 3 months after transient ischemic attack based on data from the Norwegian Stroke Registry

    Measured: 3 months

  4. Incidence of other vascular events within 1 week after transient ischemic attack

    Measured by using data from national health registries

    Measured: 1 week

  5. Cost-benefit analysis

    Economic analysis that compares the costs of admission to hospital versus outpatient assessment of patients who have had transient ischemic attacks

    Measured: 1 year

  6. Number of patients presenting with stroke within 1 year after transient ischemic attack

    Measured by using data from the Norwegian Stroke Registry

    Measured: 1 year

  7. Correlation between the ABCD2 score and the incidence of stroke within 1 year after transient ischemic attack

    Measured by comparing the ABCD2 score and the incidence of stroke within 1 year after transient ischemic attack based on data from the Norwegian Stroke Registry

    Measured: 1 year

  8. Incidence of other vascular events within 3 months after transient ischemic attack

    Measured by using data from national health registries

    Measured: 3 months

  9. Incidence of other vascular events within 1 year after transient ischemic attack

    Measured by using data from national health registries

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2014 (estimated)
  2. Study startOct 2012
  3. Primary completionJul 2014
  4. Study completionJul 2015

Resources

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
Prospective
Enrolment
584 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02038725
Sponsor's protocol ID
2012/1224
Acronym
MIDNOR-TIA
Status last verified
May 2019
First submitted
28 Dec 2013
Last updated
17 Dec 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ildstad F, Ellekjaer H, Fjaertoft H, Indredavik B. MIDNOR TIA - a prospective cohort study of 586 patients, baseline data from a subgroup of 363 patients examined with diffusion-weighted imaging. International Journal of Stroke 10(suppl 2):242, 2015 (Meeting Abstract ESOC-1527)

  • Ildstad F, Ellekjaer H, Wethal T, Lydersen S, Sund JK, Fjaertoft H, Schuler S, Horn JW, Brathen G, Midtsaether AG, Morsund AH, Lillebo ML, Seljeseth YM, Indredavik B. Stroke risk after transient ischemic attack in a Norwegian prospective cohort. BMC Neurol. 2019 Jan 3;19(1):2. doi: 10.1186/s12883-018-1225-y.

    PubMed 30606138

  • Ildstad F, Ellekjaer H, Wethal T, Lydersen S, Fjaertoft H, Indredavik B. ABCD3-I and ABCD2 Scores in a TIA Population with Low Stroke Risk. Stroke Res Treat. 2021 Feb 25;2021:8845898. doi: 10.1155/2021/8845898. eCollection 2021.

    PubMed 33708373

Questions about this trial

What is this clinical trial studying?

An observational study of Ischemic Attack, Transient and Stroke, run by Norwegian University of Science and Technology at 8 sites in Norway.

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 5 inclusion and 0 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: finished, as of the sponsor's last update on 17 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Norway. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients presenting with stroke within 1 week after transient ischemic attack (time frame: 1 week). 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 NCT02038725, which also lists 3 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 17 Dec 2021.

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