NCT02038725

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
584

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2012

Typical duration for all trials

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 28, 2013

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 16, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

December 17, 2021

Status Verified

May 1, 2019

Enrollment Period

1.7 years

First QC Date

December 28, 2013

Last Update Submit

December 2, 2021

Conditions

Ischemic Attack, TransientStroke

Keywords

RisksRisk FactorsABCD2 scorePredictive Value of TestsRisk AssessmentSeverity of Illness IndexDecision Support Techniques

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Number of patients presenting with stroke within 3 months after transient ischemic attack

    3 months

  • Correlation between the ABCD2 score and the incidence of stroke within 1 week after transient ischemic attack

    1 week

  • Correlation between the ABCD2 score and the incidence of stroke within 3 months after transient ischemic attack

    3 months

  • Incidence of other vascular events within 1 week after transient ischemic attack

    1 week

  • Cost-benefit analysis

    1 year

  • +4 more secondary outcomes

Study Arms (1)

TIA in last 2 weeks

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Ålesund Sykehus

Ålesund, Norway

Location

Kristiansund Sykehus

Kristiansund, Norway

Location

Levanger Sykehus

Levanger, Norway

Location

Molde Sykehus

Molde, Norway

Location

Namsos Sykehus

Namsos, Norway

Location

Orkdal Sykehus

Orkanger, Norway

Location

St Olavs Hospital

Trondheim, Norway

Location

Volda Sykehus

Volda, Norway

Location

Related 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 (Meeting Abstract ESOC-1527)

    RESULT

  • 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.

    PMID: 30606138RESULT

  • 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.

    PMID: 33708373RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Ischemic Attack, TransientStroke

Condition Hierarchy (Ancestors)

Brain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Bent Indredavik, PhD, Prof

    Norwegian University of Science and Technology

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 28, 2013

First Posted

January 16, 2014

Study Start

October 1, 2012

Primary Completion

July 1, 2014

Study Completion

July 1, 2015

Last Updated

December 17, 2021

Record last verified: 2019-05

Locations

NO(8)