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临床试验/NCT06995040
NCT06995040招募中不适用

Initial Predictors of Long-term Brain Resilience After Minor Ischemic Stroke: a Study Nested in the Brest Stroke Population-based Registry

University Hospital, Brest1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2025年6月18日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
1,000
试验地点
1
主要终点
Quality of life score

研究概览

简要总结

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)

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Cases of stroke in the Brest Stroke Registry (BSR)
  • Ability to sign informed consent
  • Patients followed-up > 4 years during the study period
  • NIHSS score ≤ 5 on admission
  • First stroke above 18 and before 75-year old
  • Rankin before stroke < 1
  • Possibility to draw saliva samples for genomic study
  • Possibility to perform Cerebral MRI

排除标准

  • Patients with transient neurological deficits resolving within one hour and normal brain imaging will be excluded.
  • Not affiliated to social security
  • Patient under legal protection or deprived of liberty by a judicial or administrative decision
  • Patient unable to sign informed consent
  • Patient whose follow-up will be impossible

研究组 & 干预措施

Minor ischemic stroke

Other

Patients registered in the Brest Stroke Registry who have been a minor stroke more than 4 years ago

干预措施: Cerebral MRI without contrast agent injection (Diagnostic Test)

Minor ischemic stroke

Other

Patients registered in the Brest Stroke Registry who have been a minor stroke more than 4 years ago

干预措施: saliva sample (Genetic)

Minor ischemic stroke

Other

Patients registered in the Brest Stroke Registry who have been a minor stroke more than 4 years ago

干预措施: Questionnaires (Other)

结局指标

主要结局

Quality of life score

时间窗: At inclusion

Quality of life score is evaluated with the SF-36 questionnaire. It is a dichotomized score : good or bad recovery

次要结局

  • EQ5D score(At inclusion)
  • Stroke Impact Scale(At inclusion)
  • Mortality(At inclusion)
  • Recurrence(At inclusion)
  • Rankin score(At inclusion)
  • Utility-Weighted Modified Rankin Scale(At inclusion)
  • WHO Disability Assessment Schedule (WHODAS)(At inclusion)
  • Clinical Functioning Information Tool (ClinFIT)(At inclusion)
  • Montreal Cognitive Assesment (MoCA)(At inclusion)
  • Mini Mental State Examination (MMSE)(At inclusion)
  • Center for Epidemiologic Studies-Depression (CES-D)(At inclusion)
  • Generalized Anxiety Disorder-7 (GAD-7)(At inclusion)
  • Primary Care PTSD Screen for DSM-5 (PTSD-5)(At inclusion)
  • APATHY INVENTORY IA(At inclusion)
  • Multidimensional Fatigue Inventory (MFI)(At inclusion)
  • Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)(At inclusion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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