Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT05234528 |
Other study ID # |
F2022-019 |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
February 1, 2022 |
Est. completion date |
March 1, 2025 |
Study information
Verified date |
May 2024 |
Source |
Aalborg University Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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.
Description:
Background:
In Denmark approximately 4.000 patients every year are diagnosed with Transient Ischemic
Attack (TIA). In Denmark the time-based definition of TIA is used and based on a clinical
assessment with acute, often focal neurological symptoms of vascular origin resolving
completely within 24 hours. Emerging evidence suggests however, that 1/3 of patients
experience lasting symptoms as cognitive impairments, depression, anxiety and/or fatigue,
which may impact their ability to return to their normal everyday life. Patients' own
perception of a complex and life-altering experience has been identified in the qualitative
literature. Some patients experiencing lasting symptoms and alterations in multiple life
domains like a feeling of uncertainty, vulnerability, instability and change. According to
this review, some patients reported that physical and psychosocial symptoms were not
recognized, nor acknowledged by their healthcare professionals. Education for clinicians was
recommend to enable them to understand these difficulties, improve interaction and meet the
patients' needs.
It is unknown which patients are at increased risk of experiencing the described lasting
symptoms when these symptoms arise and how it affects quality of life and return to everyday
life. Answers to these questions will allow the design and test of an evidence-based and
patient-centered intervention. The ultimate goal will be the creation of an evidence-based
guide on how to follow-up and intervene in patients with TIA to ensure the return to their
everyday life.
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.
Furthermore, the socio-economic consequences of TIA will be investigated.
Methods:
The study is designed as a prospective cohort study using mixed methods. As used in the
clinical settings in Denmark the time-based definition of TIA will be applied in this study.
The diagnosis is defined by acute focal neurological symptoms of vascular origin resolving
completely within 24 hours, thereby allowing acute ischemia on imaging.
Recruitment:
All patients diagnosed with TIA from the Stroke Unit, Aalborg University Hospital will be
screened for eligibility. Inclusion will follow a twostep approach; 1) using clinical and
demographic information from medical records, 2) receiving questionnaires at baseline, 3, 6
and 12 months follow-up.
Baseline characteristics and potential prognostic factors:
A pre-TIA modified Rankin Score (mRS) will be collected to describe the pre-TIA level of
function for the included patients.
To investigate which patients are at increased risk of experiencing the lasting symptoms
multiple potential prognostic factors will be registered at inclusion. In addition to age and
gender these include the following
- Alcohol consumption (<7, 7-14 or >14 units/week) and/or use of narcotics on a weekly
basis
- Smoking
- Housing (living in own home, nursing home or other)
- Civil status (living alone, cohabitant (with partner, children, other))
- Cardiovascular risk factors as registered in the Danish Stroke Registry
- Comorbidities in form of other chronic diseases (these will be categorized in
neurodegenerative, psychiatric, other)
- Previous stroke
- Previous TIA
- Previous diagnosis or use of medication for depression and/or anxiety
- Previous use of antihypertensive, antiplatelet, oral anticoagulation, statins,
antidiabetics
- Acute infarction on imaging
- Highest finished education and corresponding ISCED level.
- Employment status (employed >30 hours/week, employed <30 hours/week, unemployed,
retired, other)
- ABCD2 stroke risk stratification.
All interventions initiated after discharge based on the TIA will also be registered.
The diagnosis of TIA in clinical settings is challenging. Therefore, after inclusion of
patients the diagnosis of TIA will be verified independently by two stroke neurologists.
Disagreement will be resolved by a third senior stroke neurologist. This verification will
categorize patients in per protocol confirmed TIA versus non-confirmed TIA allowing for a
subgroup analysis of outcome according to this categorization. The verification will be
guided by the calculation of The Recognition of Stroke in the Emergency Room (ROSIER) score.
Considerations on sample size:
In the last 5 years, the incidence of TIA registered at the Stroke Unit, Aalborg University
Hospital ranged from 369 to 463 patients per year. The content of the project is both to
explore non-focal lasting symptoms in patients with TIA as well as prognostic factors, which
has not been done previously to this extend. Thus, a specific sample size calculation is
therefore not feasible as to many factors are unclear. Based on the average annual admission
rate the goal is to include 350-400 patients. There is a time constraint of inclusion for a
total of 12 months. This sample-size is deemed sufficient to be able to describe the
self-report outcomes across 12 months and provide preliminary data on the proportion of
patients in high risk of a poor prognosis.
Data management and statistical analysis:
Data will be handled in REDCap and analyzed in STATA. Baseline descriptive data will be
presented as medians and interquartile ranges or frequencies and percentages where
appropriate. Missing data will be handled with multiple imputation with chained equations to
impute the missing data.
To investigate the development of the included outcomes over time (baseline, 3 months, 6
months and 12 months) a longitudinal regression model will be used. For the primary effect
measure, we will implement linear regression, while for supplementary effect measures we will
use ordered logistic regression. Because of the repeated measures design the model will be a
mixed effects model with a random intercept and fixed treatment variables. After discharge
each patient can receive different follow-up and treatment interventions and the
implementation of these varies over time. For the primary analysis patients will be assigned
to each of the two main treatment tracks at baseline. An additional time-varying variable
which indicates the progress of the two treatment tracks categorized as "no further
treatment" or "further treatment" will be included in the model. For the subsequent treatment
categories, we will conduct similar secondary analyses, but stratified by main treatment arm.
For all analyses, the model will include time dependent covariates, thus, potential
prognostic factor and baseline characteristic adjustment will be conducted using Marginal
Structure models. Study results will be presented with 95% confidence intervals (CI).
To compare results with the existing literature, we will estimate mean and median outcomes
with 95% CI for each of the follow-up timepoints
The qualitative semi-structured interviews will be handled in NVivo. An explorative and
inductive thematic analysis will be performed by two researchers.