NCT06718075

Brief Summary

This study aims to evaluate the superiority of a clinical score (Canadian TIA score) compared to the currently more widely used score in clinical practice (ABCD2 score) in stratifying the risk of stroke or carotid revascularization following a transient ischemic attack at 7 days, and to assess its superiority at 90 days in a European population. Patients with transient ischemic attack are at high risk of developing a subsequent stroke, especially in the short term. Identifying patients at greater risk would allow for optimized management to provide aggressive treatment within the first days following the event. All patients attending the Emergency Medicine department of this hospital will be enrolled over a consecutive 24-month period. Approximately 800 participants are expected to take part in this study. At the time of admission to the Emergency Medicine department, the various prognostic scores relevant to the study will be completed, taking about one minute. At 7 and 90 days from the date of admission, the patient will be contacted by phone and will be administered a validated questionnaire (Questionnaire for Verifying Stroke-Free Status), which will take approximately one minute.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

December 1, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 5, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

December 5, 2024

Status Verified

December 1, 2024

Enrollment Period

3 years

First QC Date

December 1, 2024

Last Update Submit

December 1, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Occurrence of stroke or carotid revascularization

    Occurrence of stroke or carotid revascularization (endarterectomy or stenting) within 7 days of emergency department admission. Stroke will be defined as the sudden onset of neurological symptoms that persist for more than 24 hours or until death, in the absence of apparent non-vascular causes."

    From the start of recruitment to the following 7 days

Secondary Outcomes (1)

  • Occurrence of a stroke of emergency department admission, regardless of carotid revascularization

    From the start of recruitment to the following 90 days

Eligibility Criteria

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

All patients presenting to the emergency department with a diagnosis of TIA who are adults and have signed the informed consent.

You may qualify if:

  • all patients presenting to the emergency department with a diagnosis of TIA
  • all adult patients
  • all patients who have signed the informed consent

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Ischemic Attack, Transient

Condition Hierarchy (Ancestors)

Brain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Veronica Salvatore, MD

    IRCCS Azienda Ospedaliero-Universitaria di Bologna

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Veronica Salvatore, MD

CONTACT

Study Design

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

Study Record Dates

First Submitted

December 1, 2024

First Posted

December 5, 2024

Study Start

September 1, 2022

Primary Completion

August 31, 2025

Study Completion

August 31, 2025

Last Updated

December 5, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations