NCT03552926招募中不适用
Constitution of a Clinico-radiological Database and a Biobank for Patients With Lacunar Infarcts at Lariboisière Fernand-Widal and Sainte Anne Hospitals
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Time to the occurrence of cognitive decline
研究概览
简要总结
The aim of this study is to determine in patients with a recent lacunar strokes (<15 days), the natural history of cognitive disturbances and disability.
详细描述
This bi-centric cohort study aims at determining in patients with recent lacunar strokes (<15 days), the main clinical, radiological, or genetic predictive markers of recurrent stroke, cognitive impairment, dementia, depression gait disturbances and disability.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years and above
- •History of recent (less than 15 days) neurological deficit related to a small subcortical infarct (evidenced by medical history or physical examination)
- •Diagnosis of recent small subcortical infarct on MRI (hyperintensity on diffusion-weighted imaging showing an infarction in the territory of one perforating artery) presumably responsible for the corresponding neurological deficit
- •Lesion diameter mess than 20 mm
- •Ability to comply with scheduled follow-up and annual neurological evaluation
- •Affiliation to the national French health insurance (sécurité sociale)
- •Signature of informed consent
排除标准
- •Prior diagnosis of dementia according to DSM IV criteria
- •Prior severe disability with Rankin scale ≥ 4
- •Serious concomitant systemic disorder that can compromise the follow-up study;
- •Leukoencephalopathy of non-vascular origin;
- •Severe psychiatric disorder;
- •Inability to obtain an informed signed consent from the patient or his/her family;
- •Medical contraindication or refusal to undergo cerebral magnetic resonance scanning (MRI).
结局指标
主要结局
Time to the occurrence of cognitive decline
时间窗: 5 years
diagnosis of mild or major neurocognitive disorder according to DSM5
次要结局
- Recurrent stroke(5 years)
- Transient ischaemic attacks(5 years)
- Cardiovascular events(5 years)
- Attacks of migraine with aura(5 years)
- Urinary complaints(5 years)
- Dementia(5 years)
- Memory complaints(5 years)
- Depression or other mood alterations(5 years)
- Behavioural disorders(5 years)
- Balance disturbances(5 years)
- Falls(5 years)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
不适用
Endovascular Treatment in Ischemic Stroke Follow-up EvaluationStroke, AcuteNCT03776877Hopital Foch4,000
招募中
不适用
A Study for the Collection of Clinical Data for Stroke Patients and Healthy SubjectsHealth BehaviorStrokeNCT05908994Bundang CHA Hospital100
招募中
不适用
Database for Interstitial Lung DiseaseLung Diseases, InterstitialNCT04707781Medical University of Graz412
Unknown
不适用
Non-contact Sleep Apnea Identification in Neurological RehabilitationSleep ApneaStrokeNCT04803552Sleepiz AG67
Unknown
不适用
Paramedic - Norwegian Acute Stroke Prehospital ProjectTriageParamedicMobile ApplicationStrokeNCT04137874Oslo University Hospital1,300