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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Norwegian University of Science and Technology
Sponsor:
Collaborators:
St. Olavs Hospital
Helse Midt-Norge
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT02038725
First received: December 28, 2013
Last updated: July 21, 2014
Last verified: July 2014

December 28, 2013
July 21, 2014
October 2012
September 2014   (final data collection date for primary outcome measure)
Number of patients presenting with stroke within 1 week after transient ischemic attack [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Measured by using data from the Norwegian Stroke Registry
Same as current
Complete list of historical versions of study NCT02038725 on ClinicalTrials.gov Archive Site
  • Number of patients presenting with stroke within 3 months after transient ischemic attack [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Measured by using data from national health registries
  • Cost-benefit analysis [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Measured by using data from national health registries
  • Incidence of other vascular events within 1 year after transient ischemic attack [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Measured by using data from national health registries
Same as current
Not Provided
Not Provided
 
MIDNOR-TIA - a Study of 600 Patients With Transient Ischemic Attack
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 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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Blood samples

Non-Probability Sample

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

  • Ischemic Attack, Transient
  • Stroke
Not Provided
TIA in last 2 weeks
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
April 2015
September 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
No
Contact: Fredrik Ildstad, PhD student fredrik.ildstad@ntnu.no
Contact: Bent Indredavik, PhD, Prof bent.indredavik@ntnu.no
Norway
 
NCT02038725
2012/1224
No
Norwegian University of Science and Technology
Norwegian University of Science and Technology
  • St. Olavs Hospital
  • Helse Midt-Norge
Study Director: Bent Indredavik, PhD, Prof Norwegian University of Science and Technology
Norwegian University of Science and Technology
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP