Life After Transient Ischemic Attack

NCT05234528 | Active Not Recruiting

• 1 other identifier: F2022-019
• Study Type: observational
• Target: 355
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Transient ischemic attack (TIA) is defined as acute neurological symptoms of vascular origin, which resolves completely within 24 hours. However, emerging evidence indicates that up to 1/3 of patients is experiencing (non-focal) lasting symptoms, such as fatigue, depression, and anxiety. Aim: The aim of this study is to investigate self-reported lasting symptoms after TIA, timing of these symptoms as well as their potential resolution and characterize patients who have high risk for developing these symptoms. Method: This is a prospective cohort study which will include 350-400 patients with TIA from a single comprehensive stroke care center which serves the population in North Denmark Region, one of five administrative regions in Denmark (Stroke Unit, Aalborg University Hospital). Outcome measures include patient-reported outcomes collected at discharge, 3, 6 and 12 months and semi-structured interviews with a selected sample of patients. Perspective: This study will provide much needed insights into the development of lasting symptoms in patients with TIA in a cohort with presumed high external validity. Based on these results, a person-centered intervention will be designed to support the return to everyday life for patients with TIA.

Conditions

Transient Ischemic Attack; Quality of Life

Keywords

Transient Ischemic Attack; TIA; Quality of life

Outcome Measures

Primary Outcomes (1)

• Presence of fatigue at 3 months

  Fatigue using the Multidimensional Fatigue Inventory

  3 months after event

Secondary Outcomes (10)

• Presence of fatigue immediately and 3-, 6- and 12-months after discharge

  1-2 weeks, 3-, 6- and 12-months after discharge

• Presence of fatigue immediately and 3-, 6- and 12-months after discharge

  1-2 weeks, 6- and 12-months after discharge

• Presence of depression and anxiety immediately and 3-, 6- and 12-months after discharge

  1-2 weeks, 3-, 6- and 12-months after discharge

• Patients experience of their quality of life immediately and 3-, 6- and 12-months after discharge

  1-2 weeks, 3-, 6- and 12-months after discharge

• Patients experience of well-being immediately and 3-, 6- and 12-months after discharge

  1-2 weeks, 3-, 6- and 12-months after discharge

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients discharged with TIA during the study inclusion period (February 2022 to February 2023) will be registered in a screening log. Inclusion will use a twostep approach: 1. Patients are asked if clinical and demographic characteristics from their admission to the Stroke Unit can be included in the project 2. Patients are asked if they would like to participate in the 3-, 6-, and 12-months follow-up receiving questionnaires.

You may qualify if:

• Diagnosis of TIA (ICD-10 code DG45, except DG45.3 Amaurosis fugax and DG45.4 Global Transient Amnesia) and for a) accumulated TIA (\>1 event within the last 30 days): contact to the healthcare system within 30 days from symptom onset, b) not-accumulated TIA: contact to the healthcare system within 7 days from symptom onset. (as defined in the Danish Stroke Registry)
• Minimum 18 years of age
• Availability for follow-up during the study period
• Able to read and understand Danish
• Able to fill out questionnaires (assessed by the associated healthcare professional)
• Not included in any other research projects

Sponsors & Collaborators

• Aalborg University Hospital: lead
• Aalborg University: collaborator

Study Sites (1)

Aalborg University Hospital

Aalborg, 9000, Denmark

Location

Related Publications (1)

• Ebbesen BH, Grontved S, Hedegaard JN, Johnsen SP, Andreasen J, Figlewski K, Porobic M, Rathleff MS, Modrau B. Long-Term Fatigue Following Transient Ischemic Attack: A Prospective Cohort Study. Neurology. 2025 Jun 10;104(11):e213605. doi: 10.1212/WNL.0000000000213605. Epub 2025 May 14.

  PMID: 40367404 DERIVED

MeSH Terms

Conditions

Ischemic Attack, Transient

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Birgitte H Ebbesen, PT, MSc

  Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 1, 2022
• First Posted: February 10, 2022
• Study Start: February 1, 2022
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2025
• Last Updated: May 2, 2024

Record last verified: 2024-05

Locations

DK (1)