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

Stroke Clinical Trial

— MIDNOR-TIA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02038725
• Other study ID #: 2012/1224
• Status: Completed
• Start date: October 2012
• Est. completion date: July 2015

Study information

• Verified date: May 2019
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 584
• Est. completion date: July 2015
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Ischemia
• Ischemic Attack, Transient
• Stroke

Locations

Country	Name	City	State
Norway	Ålesund Sykehus	Ålesund
Norway	Kristiansund Sykehus	Kristiansund
Norway	Levanger Sykehus	Levanger
Norway	Molde Sykehus	Molde
Norway	Namsos Sykehus	Namsos
Norway	Orkdal Sykehus	Orkanger
Norway	St Olavs Hospital	Trondheim
Norway	Volda Sykehus	Volda

Sponsors (3)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Helse Midt-Norge, St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (3)

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 (Meet

Ildstad F, Ellekjær H, Wethal T, Lydersen S, Fjærtoft 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. — View Citation

Ildstad F, Ellekjær H, Wethal T, Lydersen S, Sund JK, Fjærtoft H, Schüler S, Horn JW, Bråthen G, Midtsæther AG, Morsund ÅH, Lillebø ML, Seljeseth YM, Indredavik B. Stroke risk after transient ischemic attack in a Norwegian prospective cohort. BMC Neurol. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of patients presenting with stroke within 3 months after transient ischemic attack	Measured by using data from the Norwegian Stroke Registry	3 months
Secondary	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
Secondary	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
Secondary	Incidence of other vascular events within 1 week after transient ischemic attack	Measured by using data from national health registries	1 week
Secondary	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
Secondary	Number of patients presenting with stroke within 1 year after transient ischemic attack	Measured by using data from the Norwegian Stroke Registry	1 year
Secondary	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
Secondary	Incidence of other vascular events within 3 months after transient ischemic attack	Measured by using data from national health registries	3 months
Secondary	Incidence of other vascular events within 1 year after transient ischemic attack	Measured by using data from national health registries	1 year