Assessment of One-shot Cardiac-cervical-intracranial MRI in the Etiological Work up of Ischemic Stroke and Transient Ischemic Attacks
试验速览
- 阶段
- 不适用
- 入组人数
- 244
- 试验地点
- 2
- 主要终点
- To evaluate the consistency between the reference strategy and the cci-MR strategy for etiological work up according to the ASCOD classification, in ischemic stroke and TIA patients
研究概览
简要总结
Stroke is a major public health issue in developed countries. A full etiological work up within a short time is critical to implement the appropriate preventive treatment. The etiological work up is actually based on a clinical examination and on a group of paraclinical examinations. The realization of the standard strategy is time consuming, and increase the cost of the medical care. A non-invasive one-shot examination of the heart, the aorta and the cervical and intracranial arteries (cci-MRI) could overcome these disadvantages.The investigator therefore propose to carry out an overall assessment of the performance of the cci-MR in the etiological work up of ischemic strokes and TIAs compared to the reference strategy
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Man or woman aged from 18 to 85 years old,
- •Patients victims of an ischemic stroke or a TIA in the 2 days before inclusion, Symptoms thought to be consistent with TIA were those defined by the ad hoc Committee established by the Advisory Council for the National Institute of Neurological and Communicative Disorders and Stroke65
- •Rankin score: mRS ≤3
- •Patient having given their free written and informed consent, or preliminary oral informed consent attested by a third party followed by signed informed consent as soon as possible,
- •Affiliated to a social security scheme or equivalent,
- •That are not the subject of any legal protection measures
排除标准
- ••TIA symptoms limited to isolated numbness,
- •changes, or isolated dizziness/vertigo
- •Agitation, severe swallowing
- •Contraindication to an MRI and the injection of gadolinium,
- •Known history of hypersensitivity to the MRI contrast product,
- •Risk of pregnancy or known pregnancy revealed when questioned, Breastfeeding,
- •Patient unable to understand or poorly understanding French.
结局指标
主要结局
To evaluate the consistency between the reference strategy and the cci-MR strategy for etiological work up according to the ASCOD classification, in ischemic stroke and TIA patients
时间窗: Within 8 days after hospitalization
The primary endpoint will be based on the consistency for each patient of the etiological work up according to the ASCOD classification evaluated with cci-MR in comparison of the reference strategy
次要结局
- To assess the improvement of the detection of myocardial scar with cci-MR compared to reference strategy(Within 8 days after hospitalization)
- To evaluate the agreement between cci-MR and the reference method for each etiological subgroup: in the context of ischemic stroke or TIA.(Within 8 days after hospitalization)
- To assess the atherosclerotic burden (coronary, intracranial, cervical, aortic) assessed with cci-MR compared to the reference strategy,(Within 8 days after hospitalization)
- To assess the rate of additional cardiologic advice recommended according to the opinion of the expert committee from data obtained with cci-MR and with the reference strategy(Within 8 days after hospitalization)
- To assess the feasibility of the examinations (rate of completed examinations, deadline to obtain each examination, deadline to obtain all examinations including in each strategy)(Within 8 days after hospitalization)
- To assess the additional yield of cci-MR in cryptogenic patients and in those with embolic stroke of undetermined source (ESUS) with the reference strategy (ref Hart et al., Lancet Neurol. 2014:13:429-438.)(Within 8 days after hospitalization)
- To assess the rate of TEE recommended according to the opinion of the expert committee from data obtained with cci-MR and the reference strategy(Within 8 days after hospitalization)
- To assess the feeling of the patient about cci-MR and the reference strategy(Within 8 days after hospitalization)
- To assess the reproducibility of the assessment of the cci-MR results(Within 8 days after hospitalization)
- To assess the preventive treatment recommended (antithrombotic drugs and specific treatments) according to the opinion of the expert committee from data obtained with cci-MR and with the reference strategy(Within 8 days after hospitalization)