Stroke Clinical Trial
— MIDNOR-TIAOfficial title:
MIDNOR-TIA - a Prospective Cohort Study of 600 TIA Patients in Central Norway
NCT number | NCT02038725 |
Other study ID # | 2012/1224 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 2012 |
Est. completion date | July 2015 |
Verified date | May 2019 |
Source | Norwegian University of Science and Technology |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Norwegian University of Science and Technology | Helse Midt-Norge, St. Olavs Hospital |
Norway,
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
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 |
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