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Completed

NCT Number: NCT02038725

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kristiansund Sykehus, Kristiansund, Norway

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Treatment and study plan

Primary outcomes

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

    Time frame: 1 week

    Measured by using data from the Norwegian Stroke Registry

Secondary outcomes

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

    Time frame: 3 months

    Measured by using data from the Norwegian Stroke Registry

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

    Time frame: 1 week

    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

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

    Time frame: 3 months

    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

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

    Time frame: 1 week

    Measured by using data from national health registries

  5. Cost-benefit analysis

    Time frame: 1 year

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

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

    Time frame: 1 year

    Measured by using data from the Norwegian Stroke Registry

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

    Time frame: 1 year

    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

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

    Time frame: 3 months

    Measured by using data from national health registries

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

    Time frame: 1 year

    Measured by using data from national health registries

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • Helse Midt-Norge
  • St. Olavs Hospital

Registry information

Official study title

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

Acronym: MIDNOR-TIA

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Jan 16, 2014
Registry last updated
Dec 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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