跳至主要内容
临床试验/NCT04504695
NCT04504695招募中不适用

Prediction of Patient-specific Outcomes After Interventional Neuroradiology Procedures

University Hospital, Brest1 个研究点 分布在 1 个国家目标入组 1,600 人开始时间: 2021年1月4日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,600
试验地点
1
主要终点
Identification of predictive factors

研究概览

简要总结

Stroke is either an obstruction (ischemic stroke) or the rupture of a blood vessel in the brain (ruptured aneurysm). It can happen at any age in adults. Because of the risk of irreversible brain damage, it is an absolute medical emergency.

An ischemic stroke (stroke) is the result of a lack of oxygen supply to a part of the brain. It can be one of many causes of stroke as a result of a thrombosis (occlusion) of the internal carotid artery or a cerebral embolism (migration of a clot or debris of fatty deposits) from a carotid stenosis. In both cases part of the brain is less irrigated. There will then be a neurological deficit (paralysis) more or less important corresponding to the affected cerebral territory. The deficit may concern the whole hemicorps (hemiplegia) or a part of the body (upper or lower limb) and sometimes is associated with facial paralysis and/or language disorders.

A brain aneurysm occurs when the wall of an intracranial artery expands abnormally, creating a pocket of blood. It is often caused by weakness in the vascular tissue, but it can also occur later in life due to illness, head injury, oral contraceptives or certain lifestyle habits (smoking, excessive alcohol consumption). Sudden increases in pressure due to stress or strenuous exercise can serve as a trigger.

Interventional Neuroradiology (INR) is a medical specialty that manages stroke patients using imaging to perform the medical procedure and thereby limit openings and their associated risks. This specialty has a growing place in modern medicine.

In order to improve the quality of care, patient safety and functional outcomes, it is necessary to keep patient information. A database storing patient data from the NRI department will make it possible to track patients since their arrival at the Brest University Hospital. Thanks to this structured database, clinical studies will be facilitated, making it possible to advance knowledge of the pathology and its treatments.

From the bibliographical research, we can conclude as to the current state of the facts: there is currently no method for predicting the functional results of the interventional neuroradiologist's patient based on automated learning.

A strategy based on an innovation programme is therefore being implemented over several years, the first stage of which is the retrospective data study which was approved by the ethics committee on 12/09/2019 and the second stage is the prospective data study.

This innovation program requires the most complete and homogeneous data possible.

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

入选标准

  • Major patient carrying either a small or large, ruptured or unruptured aneurysm or a thrombectomy, with in both cases, a treatment procedure carried out in the interventional neuroradiology department of the Brest CHRU.

排除标准

  • Age < 18 years old
  • Incapacitated patients of full age (under guardianship or curatorship)
  • Refusal to participate
  • Follow-up impossible

结局指标

主要结局

Identification of predictive factors

时间窗: 24 months

Number of predictive factors (pre- and intra-operative data) for the angiographic success of the procedure (intracranial aneurysm or thrombectomy).

次要结局

  • Neurological evolution(24 months)
  • Clinical evolution(24 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Prediction of Patient-specific Outcomes After... | 临床试验