Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Minor ischemic stroke | Other | Patients registered in the Brest Stroke Registry who have been a minor stroke more than 4 years ago |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cerebral MRI without contrast agent injection | Diagnostic Test | Cerebral MRI at inclusion or after |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life score | Quality of life score is evaluated with the SF-36 questionnaire. It is a dichotomized score : good or bad recovery | At inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| EQ5D score | 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) | At inclusion |
| Stroke Impact Scale |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Serge TIMSIT, Pr | Contact | 298147349 | +33 | serge.timsit@chu-brest.fr |
| Name | Affiliation | Role |
|---|---|---|
| Serge TIMSIT, Pr | CHU de Brest | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Brest | Recruiting | Brest | 29609 | France |
All collected data that underlie results in a publication
Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.
Not provided
Not provided
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
Not provided
Not provided
Retrospective cohort data for baseline characteristics and prospective data for more than 4 years information.
Methodology that will be developed will include both classical statistical analysis and algorithm development based on AI approaches.
Not provided
Not provided
Not provided
Not provided
| saliva sample | Genetic | Saliva sample for DNA analysis at inclusion or send to their home. |
|
| Questionnaires | Other | Quality of life and cognitive questionnaires 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) |
| At inclusion |
| Mortality | Mortality is collected from the Brest Stroke Registry, and concerns patients who have been stroke 4 years ago. | At inclusion |
| Recurrence | Recurrence is collected from the Brest Stroke Registry, and concerns patients who have been stroke 4 years ago. | At inclusion |
| Rankin score | 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. | At inclusion |
| Utility-Weighted Modified Rankin Scale | 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). | At inclusion |
| WHO Disability Assessment Schedule (WHODAS) | 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) | At inclusion |
| Clinical Functioning Information Tool (ClinFIT) | It is an auto-questionnaire to evaluate patient functioning. There are 30 questions, with score ranging from 0 (no problem) to 30 (complete problem). | At inclusion |
| Montreal Cognitive Assesment (MoCA) | 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. | At inclusion |
| Mini Mental State Examination (MMSE) | 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. | At inclusion |
| Center for Epidemiologic Studies-Depression (CES-D) | 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). | At inclusion |
| Generalized Anxiety Disorder-7 (GAD-7) | 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. | At inclusion |
| Primary Care PTSD Screen for DSM-5 (PTSD-5) | It is an auto-questionnaire to evaluate stroke experience. there are 5 questions with 2 answers Yes/No | At inclusion |
| APATHY INVENTORY IA | 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). | At inclusion |
| Multidimensional Fatigue Inventory (MFI) | 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) | At inclusion |
| Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) | It is a questionnaire to evaluate cognitive declin, with 16 questions, with score ranging from 1 (much better) to 5 (much worse) | At inclusion |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |