Clinical trial NCT02038725: MIDNOR-TIA - a Study of 600 Patients With Transient Ischemic Attack
Official title: MIDNOR-TIA - a Prospective Cohort Study of 600 TIA Patients in Central Norway
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Attack, Transient
Stroke
Keywords: Risks
Risk Factors
ABCD2 score
Predictive Value of Tests
Risk Assessment
Severity of Illness Index
Decision Support Techniques
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Helse Midt-Norge
First posted: 2014-01-16
Enrollment: 584
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred to a hospital in Central Norway with a recent probable or possible transient ischemic attack

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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of patients presenting with stroke within 1 week after transient ischemic attack
timeFrame: 1 week
Secondary outcomes:
measure: Number of patients presenting with stroke within 3 months after transient ischemic attack
timeFrame: 3 months
measure: Correlation between the ABCD2 score and the incidence of stroke within 1 week after transient ischemic attack
timeFrame: 1 week
measure: Correlation between the ABCD2 score and the incidence of stroke within 3 months after transient ischemic attack
timeFrame: 3 months
measure: Incidence of other vascular events within 1 week after transient ischemic attack
timeFrame: 1 week
measure: Cost-benefit analysis
timeFrame: 1 year
measure: Number of patients presenting with stroke within 1 year after transient ischemic attack
timeFrame: 1 year
measure: Correlation between the ABCD2 score and the incidence of stroke within 1 year after transient ischemic attack
timeFrame: 1 year
measure: Incidence of other vascular events within 3 months after transient ischemic attack
timeFrame: 3 months
measure: Incidence of other vascular events within 1 year after transient ischemic attack
timeFrame: 1 year
Other outcomes:
Locations:
city: Kristiansund
country: Norway
facility: Kristiansund Sykehus
city: Levanger
country: Norway
facility: Levanger Sykehus
city: Molde
country: Norway
facility: Molde Sykehus
city: Namsos
country: Norway
facility: Namsos Sykehus
city: Orkanger
country: Norway
facility: Orkdal Sykehus
city: Trondheim
country: Norway
facility: St Olavs Hospital
city: Volda
country: Norway
facility: Volda Sykehus
city: Ålesund
country: Norway
facility: Ålesund Sykehus
Study officials:
affiliation: Norwegian University of Science and Technology
name: Bent Indredavik, PhD, Prof
role: STUDY_DIRECTOR
References:
citation: 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)
citation: 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.
citation: 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.