@neurIST : Informatique biomédicale intégrée Pour la Gestion Des anévrismes cérébraux
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20,000
- 试验地点
- 22
- 主要终点
- Disease model validation
研究概览
简要总结
The primary aim of the SwissNeuroFoundation AneurysmDataBase Project is to implement information technology based tools to create and use a holistic reference database specific to intracranial aneurysms (IA).
The SwissNeuroFoundation AneurysmDataBase are concerned with generating the data with which to populate this database.
The purpose for populating the database are to:
- Screen for and evaluate markers of risk for intracranial aneurysm formation and aneurysm rupture. Are considered as markers the following: genetics factors, microbiota, environmental factors, congenital factors (ie: cerebrovascular anatomical variants), transcriptomics signature, proteomics signature,shape characteristics, haemodynamics characteristics.
- Screen for and evaluate prognostic factors of outcome regarding different management strategies including watchful observation, microsurgical treatment, endovascular treatment or any combination thereof.
- Implement and evaluate patient-specific management protocols integrating all available information.
- Evaluate the impact of the database and use of tools to improve care, reduce costs, support knowledge discovery and promote new industrial developments.
详细描述
Clinical history, imaging data, biological samples and information derived from are the main items to be captured to the SwissNeuroFoundation AneurysmDataBase. No limits are set on the number of healthy volunteers and patient cases for whom data can be entered to the SwissNeuroFoundation AneurysmDataBase.
Participants will be recruited from the following sources:
- Patients arriving at partner clinical centers either as newly diagnosed (incidental cases) or already known for the disease (prevalent cases)
- Healthy volunteers answering a call, randomly selected subjects from a known population that consent to participate or non genetically linked family members of patients that consent to participate
- Family members of patients identified as having a familial history of intracranial aneurysm (IA).
Points of consent:
The specific items on which participants are asked to consent:
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
- 是
入选标准
- •able to provide consent or, in the event that a patient is incapable of providing consent, that a person is legally authorized to do so on behalf of the patient according to legal and ethical requirements of the country where the clinical centre is located.
- •must have an angiographically proven intracranial aneurysm (MRA< CTA< DSA accepted).The determination of SAH requires the presence of a subarachnoid haemorrhage be verified on CT or by lumbar puncture.
- •MRA: Magnetic Resonance Angiography CTA: Computed Tomography Angiography DSA: Digital Subtracted Angiography
排除标准
- •failure of a candidate to contribute clinical data,
- •refusal to provide informed consent.
研究组 & 干预措施
IA Patients
Patients with one or more identified intracranial aneurysm, none of which are believed to have ruptured.
IA + SAH Patients
Patients with one or more identified intracranial aneurysm, at least one of which has been radiologically or surgically determined to have ruptured.
Familiy members
Individuals selected on review of a patient's family tree and contacted by said patient, who agree to be approached for recruitment. In affected families each member will be identified as: proband, affected, unaffected, unknown, or not genetically linked.
Healthy Volunteers
Individuals, accompanying or contacted by a patient, or responding to open advertisement, or randomly selected in a defined population who agree to be approached for recruitment.
结局指标
主要结局
Disease model validation
时间窗: 5 years
Validation and improvement of the holistic disease model
次要结局
- Disability(20 years)
- Aneurysm growth(20 years)
- Cranial nerves status(20 years)
- Occurence of vasospasm(20 years)
- Radiological aneurysm exclusion(20 years)
- Adverse events(20 years)
- Occurence of hydrocephalus(20 years)
- Delayed Cerebral Injury (DCI)(20 years)
- Cure(20 years)
- Life expectancy(20 years)
- Recurrence(20 years)
- Neo-aneurysm formation(20 years)
- Neurological status(20 years)
- Quality of life(20 years)
- Neuropsychological performance(20 years)
研究者
Philippe Bijlenga
Associate Professor
University Hospital, Geneva