Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05132465 |
| Other study ID # |
UoL001512 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 12, 2021 |
| Est. completion date |
September 2024 |
Study information
| Verified date |
March 2024 |
| Source |
University of Liverpool |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
What research question is being addressed?
Can improve the prediction of adverse outcomes be improved for people following a stroke to
optimise their treatment and care?
How is it of relevance and importance to patients and public?
Following a stroke, people are at a higher risk of developing certain conditions including
heart failure, another stroke and atrial fibrillation, a type of irregular heart rhythm. In
the proposed study, the investigators will look at factors which may increase a person's risk
of such conditions following stroke. From this, the investigators will determine if risk
scores for these conditions can be improved for people post-stroke. This could help doctors
decide what treatments are best.
Who would be eligible?
All adults at participating hospitals who have had an ischaemic stroke (where the stroke is
caused by loss of blood flow to the brain) or a transient ischaemic attack ('mini-stroke')
confirmed by a stroke doctor. All patients will be asked to take part in the study, or their
family members may be asked to provide advice on their behalf if the patient is unable to.
Where is the study being conducted?
At participating hospitals in England and Wales.
What will the participants undergo?
At the time of stroke, patients have a lot of information collected about their health, the
investigators will copy information from patient's medical records about their health after
they agree to take part in the study. Patients or their family members will also be asked to
complete some additional brief questionnaires about their quality of life, wellbeing and
fatigue. Some questionnaires such as for cognitive function are already collected for
patients following a stroke, but where this information has not been collected, it will be
collected for the study. The investigators will ask the patients if they can be contacted in
12-months to repeat the questionnaires and information collected about their health.
Description:
Study purpose and design.
People with prior stroke are at a high-risk of incident adverse cardiovascular outcomes
including heart failure, atrial fibrillation (AF), recurrent stroke and vascular cognitive
impairment and dementia. However, there is a need to clarify the underlying risk factors for
these outcomes specific to post-stroke populations. Extensive research has been conducted to
identify individuals at high-risk of cardiovascular disease through the development of risk
prediction models. This has led to the incorporation of risk models for cardiovascular
disease into guidelines for clinical practice with an aim to improve patient-centred care and
decision-making. Risk factors frequently incorporated in such models include age, male sex,
hypertension, cholesterol, smoking, and diabetes mellitus. Although some risk prediction
models have examined cardiovascular outcomes such as AF in people post-stroke, further
research is needed to refine these models and make recommendations for implementation to
clinical practice. Identifying precise risk prediction models for cardiovascular disease and
cardiovascular-related complications in people post-stroke is needed to target screening for
conditions (such as AF) and develop targeted intervention strategies specific to this
population.
Quality assurance plan
Pseudo-anonymised data using the unique, non-identifiable participant ID will be collected in
an electronic case report form using Research Electronic Data Capture (REDCapÍž
https://www.project-redcap.org). The data entered in to REDCap for the first 20 patients
recruited at each site will be remotely checked for completeness. The data entered onto
REDCap will be checked against electronic medical records and paper questionnaires at
selected sites.
Data checks
The data fields in REDCap have been set with predefined rules for range or consistency and
error messages will display when these rules are violated.
Sample size assessment
As one of the main aims of the study is to examine post-stroke risk prediction models for AF,
this will be used to determine the sample size. Post-stroke prevalence of AF has been
estimated at approximately 24%. Based on the 24% and with a conservative estimate of 15 cases
required per variable in the model, 195 cases would be appropriate for a 13-variable model,
which is the maximum number of variables included in previous AF prediction models.
Therefore, 815 participants would give approximately 195 patients who develop AF required for
the model. The study aims to recruit these participants and 20% extra to account for
potential loss to follow-up, resulting in a minimum of 978 participants.
Statistical analysis plan
All data collected will be quantitative. Data will be analysed by members of the research
team at the Liverpool Centre for Cardiovascular Science. Cox proportional hazard models
adjusted for potential confounding factors will be used to examine associations between risk
factors and cardiovascular outcomes and mortality. Risk models identified in previous studies
for AF and cardiovascular-related outcomes including cardiovascular disease, physical
function, cognitive impairment and dementia, quality-of-life, and all-cause and
cardiovascular mortality will be examined in the L-HARP stroke cohort. Receiver operating
characteristic curves will be constructed, and Harrell C indexes (i.e. area under the curve)
will be estimated as a measure of model performance and compared using the DeLong test.
In addition to traditional epidemiological approaches to risk prediction modelling, machine
learning methodologies will also be examined. Machine learning has been shown to produce
comparable results to traditional cardiovascular disease risk prediction scores, but with
advantages such as examining all available data in an unbiased approach which could lead to
the discovery of new relationships among data. As the sample is not very large, traditional
machine learning techniques including k-Nearest Neighbours, random forest, and decision tree
will be utilised rather than deep learning techniques which are usually applied to very large
datasets. A subset of the data will be used for the training of the model and the rest of the
data will be used for the evaluation of the model. The model derived from machine learning
will be compared to risk prediction models described in previous studies. The accuracy,
specificity, sensitivity, positive predictive value and negative predictive value of the
models will be compared.
