CHU de Brest
Brest, 29609, France
Location status: Recruiting
NCT Number: NCT06995040
The objective of this clinical trial is to develop, based on patients' initial characteristics (in the first few weeks following the stroke), a predictive model of quality of life more than 4 years after the stroke in patients who have suffered a minor ischemic stroke.
The main question it aims to answer is:
- Is it possible to predict the quality of life of patients who have suffered a minor ischemic stroke based on their initial characteristics?
To do this, retrospective and prospective data collected as part of the study will be analyzed using a conventional statistical approach and algorithms based on AI approaches in order to create a predictive model.
Participants will be asked to:
* Complete questionnaires * Provide a saliva sample (optional) * Undergo an MRI scan (optional)
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Brest, 29609, France
Location status: Recruiting
Brain resilience: The human brain shows remarkable inter-individual differences in coping with pathological insults. This is observed in particular after ischemic stroke with patients with similar types of stroke showing very different functional outcomes ranging from complete recovery to severe disability.
Minor stroke: In population-based studies, approximately two-thirds of ischemic stroke patients have mild deficits. Minor stroke is generally defined as a National Institute of Health Stroke Scale (NIHSS) of 5 or less. The term minor stroke takes into account certain deficits but not the fact that some can have a more profound impact on quality of life than others. Minor strokes have a 30-day fatality rate very low but approximately 30% of patients with minor strokes have poor functional outcomes at 90-days. In patients with minor stroke impairment of health-related quality of life is however present in 35.8% of case at 3-months.Long term outcome (> 90-days) is less well known. An analysis of the population-based Oxford Vascular Study showed that, in minor stroke with an NIHSS < 3, the incidence of post-event dementia at 1 year was 8.2% (6.2-10.2). The 5-year risk of dementia was found associated with age, event severity, previous stroke, dysphasia, baseline cognition, low education, pre-morbid dependency, leucoaraiosis, and diabetes. Cognitive sequelae of minor strokes are frequent involving overall executive functions, attention, working memory, processing speed, visual & verbal memory, verbal fluency and other. There is a need for big data, big imaging: many studies have less than 100 patients, none had 1000 patients
The principal objective is to develop, from initial (first weeks after stroke onset) patients' characteristics, a predictive model of quality of life more than 4 years after stroke onset in patients with minor ischemic stroke.
Patients included in the Brest Stroke Registry (all cases of stroke in patients aged above 15 years occurring in a defined area known as the "Pays de Brest", in Brittany, western France) who meet the inclusion and non-inclusion criteria will be proposed to participate to the study to have either a telephone interview or a face-to-face interview with a neurologist and a clinical research technician more than 4 years from stroke hospitalization.
In the case of telephone interview they will be proposed to have a saliva sample for DNA analysis send to their home that will need to be send back to the hospital.
In the case of face-to-face interview, patient will be proposed to have on the spot a saliva sample for DNA and a cerebral MRI.
Chaining patients from the BRE and hospital medical record: Pairing between databases-i.e BRE and hospital medical electronic record will be established.
Retrospective cohort data for baseline characteristics and prospective data for more than 4 years information.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Cerebral MRI at inclusion or after
Saliva sample for DNA analysis at inclusion or send to their home.
Quality of life and cognitive questionnaires at inclusion
Time frame: At inclusion
Quality of life score is evaluated with the SF-36 questionnaire. It is a dichotomized score : good or bad recovery
Time frame: At inclusion
It is a questionnaire to describe patient's health with 5 items (Mobility; Autonomy; Activity; Pain/Discomfort; Anxiety/Depression) with 5 anwers each (No problem/light problems/moderate problem/serious problems/incapable)
Time frame: At inclusion
Stroke Impact Scale includes 59 items and assesses 8 domains: Strength (4 items), Hand function (5 items), ADL/IADL (10 items), Mobility (9 items), Communication (7 items), Emotion (9 items), Memory and thinking (7 items), Participation/Role function (8 items)
Time frame: At inclusion
Mortality is collected from the Brest Stroke Registry, and concerns patients who have been stroke 4 years ago.
Time frame: At inclusion
Recurrence is collected from the Brest Stroke Registry, and concerns patients who have been stroke 4 years ago.
Time frame: At inclusion
It is a scale about disability after stroke. The score is between 0 (no symptom) to 5 (serious disability). The study uses Rankin score dichotomized in good [0-1] and bad [2-5] prognosis.
Time frame: At inclusion
The Modified Rankin Scale is a measure of functional outcome after stroke, evaluating the degree of disability or dependence in daily life. There is 7 grades ranging from 0 (no symptoms) to 6 (death).
Time frame: At inclusion
It is an auto-questionnaire of disability in daily life. There are 15 questions with 5 anwers ranging from 0 (No disability) to 5 (extreme disability/incapability)
Time frame: At inclusion
It is an auto-questionnaire to evaluate patient functioning. There are 30 questions, with score ranging from 0 (no problem) to 30 (complete problem).
Time frame: At inclusion
It is a cognition test with 7 items (visuospatial; designation; memory; attention; langage; abstraction; orientation). The total score is ranging from 0 to 30 points.
Time frame: At inclusion
It is a cognition test with 6 items (orientation ; learning ; attention/calculation ; reminder; langage ; visuospatial constructive). The total score is ranging from 0 to 30 points.
Time frame: At inclusion
It is an auto-questionnaire to evaluate depression with 20 questions. There are 6 answers with score ranging from 0 to 6 (0 : Never/very rarely ; 1: rarely; 2 :quite often; 3: frequently/always).
Time frame: At inclusion
It is an auto-questionnaire for screening of generalized anxiety disorder with 7 questions. There are 4 answers : Never / Several days / More than half the days / Almost every day.
Time frame: At inclusion
It is an auto-questionnaire to evaluate stroke experience. there are 5 questions with 2 answers Yes/No
Time frame: At inclusion
It is an auto-questionnaire to obtain information on the presence of apathy in patients with brain disorders. There are 3 items : emotional blunting; loss of initiative; loss of interest, with score ranging from 0 (mild) to 12 (severe).
Time frame: At inclusion
It is an auto-questionnaire to evaluate fatigue. There are 10 items with score ranging from 1 (not agree at all) to 5 (completely agree)
Time frame: At inclusion
It is a questionnaire to evaluate cognitive declin, with 16 questions, with score ranging from 1 (much better) to 5 (much worse)
Contact information is provided by the study sponsor or research team.
University Hospital, Brest
Other
Initial Predictors of Long-term Brain Resilience After Minor Ischemic Stroke: a Study Nested in the Brest Stroke Population-based Registry
Acronym: BREMISS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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