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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

Brief 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. 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 Age, Blood pressure, Clinical features, Duration of TIA, Diabetes (ABCD2) score is a sufficient 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.

Detailed Summary:
Sponsor: Norwegian University of Science and Technology

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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
  • 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
  • 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
  • Incidence of other vascular events within 1 week after transient ischemic attack [ Time Frame: 1 week ]
    Measured by using data from national health registries
  • 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
  • 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
  • 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
  • Incidence of other vascular events within 3 months after transient ischemic attack [ Time Frame: 3 months ]
    Measured by using data from national health registries
  • Incidence of other vascular events within 1 year after transient ischemic attack [ Time Frame: 1 year ]
    Measured by using data from national health registries


Original Secondary Outcome: Same as current

Information By: Norwegian University of Science and Technology

Dates:
Date Received: December 28, 2013
Date Started: October 2012
Date Completion:
Last Updated: October 26, 2015
Last Verified: October 2015