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

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Ischemic Attack, Transient

• Study Type: Observational
• Enrollment (Actual): 584

Contacts and Locations

Study Locations

• Norway
  • Kristiansund, Norway
    • Kristiansund Sykehus
  • Levanger, Norway
    • Levanger sykehus
  • Molde, Norway
    • Molde Sykehus
  • Namsos, Norway
    • Namsos Sykehus
  • Orkanger, Norway
    • Orkdal Sykehus
  • Trondheim, Norway
    • St Olavs Hospital
  • Volda, Norway
    • Volda Sykehus
  • Ålesund, Norway
    • Ålesund sykehus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
TIA in last 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients presenting with stroke within 1 week after transient ischemic attack	Measured by using data from the Norwegian Stroke Registry	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients presenting with stroke within 3 months after transient ischemic attack	Measured by using data from the Norwegian Stroke Registry	3 months
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	1 week
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	3 months
Incidence of other vascular events within 1 week after transient ischemic attack	Measured by using data from national health registries	1 week
Cost-benefit analysis	Economic analysis that compares the costs of admission to hospital versus outpatient assessment of patients who have had transient ischemic attacks	1 year
Number of patients presenting with stroke within 1 year after transient ischemic attack	Measured by using data from the Norwegian Stroke Registry	1 year
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	1 year
Incidence of other vascular events within 3 months after transient ischemic attack	Measured by using data from national health registries	3 months
Incidence of other vascular events within 1 year after transient ischemic attack	Measured by using data from national health registries	1 year

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Collaborators: St. Olavs Hospital; Helse Midt-Norge

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2012
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: December 28, 2013
• First Submitted That Met QC Criteria: January 14, 2014
• First Posted (Estimate): January 16, 2014

Study Record Updates

• Last Update Posted (Actual): December 17, 2021
• Last Update Submitted That Met QC Criteria: December 2, 2021
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Risk Factors; Risk Assessment; Decision Support Techniques; Severity of Illness Index; Predictive Value of Tests; Risks; ABCD2 score
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Ischemia; Ischemic Attack, Transient
• Other Study ID Numbers: 2012/1224

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No