Vertebrobasilar Flow Evaluation and Risk of Transient Ischemic Attack and Stroke

椎基底动脉血流评估以及短暂性脑缺血发作和中风的风险

• 批准号: 7622079
• 负责人: Sepideh Amin-Hanjani
• 金额: $ 38.37万
• 依托单位: UNIVERSITY OF ILLINOIS AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-07-01 至 2013-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7622079
• 关键词: Adult; Algorithms; Angioplasty; Blinded; Blood Circulation; Blood flow; Cause of Death; Cerebrum; Clinical; Clinical Trials; Cohort Studies; Data; Disease; Disease Management; Distal; Enrollment; Epidemiology; Etiology; Evaluation; Event; Functional disorder; Future; Goals; Health Care Costs; Image; Individual; Intervention; Laboratories; Logistics; Longitudinal Studies; Magnetic Resonance Angiography; Measurement; Measures; Medical; Methods; Modeling; Monitor; Observational Study; Operative Surgical Procedures; Patients; Perfusion; Physicians; Population; Predictive Factor; Public Health; Randomized Controlled Clinical Trials; Recruitment Activity; Recurrence; Risk; Screening procedure; Selection Criteria; Site; Stenosis; Stroke; Survival Analysis; Testing; Time; Tissues; Transient Ischemic Attack; base; cost; disability; follow-up; hazard; hemodynamics; high risk; patient population; prospective; public health relevance; risk selection; success; tool

DESCRIPTION (provided by applicant): Over one third of the 700,000 strokes suffered annually occur in the posterior circulation, a major cause of which is atherosclerotic vertebrobasilar occlusive disease. Symptomatic vertebrobasilar disease carries a high annual stroke risk, averaging 10-15% per year. Advances in endovascular angioplasty and stenting have created new treatment options, but these interventions carry significant risks, and selection criteria for determining appropriate candidates remain uncertain. Prior to embarking on expensive large-scale randomized trials of intervention, it is necessary to define the appropriate high risk population most likely to benefit from treatment. The overall goal of this study is to define the population of patients with vertebrobasilar disease at highest risk of recurrent stroke. The results will be well poised to form the basis for future clinical trials of endovascular or surgical interventions. Preliminary retrospective data indicates that stroke risk in vertebrobasilar disease is strongly related to compromised intracranial blood flow, the extent of which can be measured noninvasively using quantitative magnetic resonance angiography (QMRA). The objective is to conduct a prospective multi-center observational study of patients with symptomatic angiographically confirmed vertebrobasilar stenosis (e 50%) or occlusion to test the hypothesis that those who demonstrate compromised blood flow are at higher stroke risk. Upon enrollment, subjects will undergo hemodynamic assessment with QMRA to assess large vessel flow, and MR perfusion to assess tissue level perfusion, in the vertebrobasilar territory. Subjects will be prospectively designated as demonstrating compromised or normal cerebral flow, based upon existing preliminary data; the results will be kept blinded from treating physicians and patients. Baseline clinical, laboratory, and epidemiological data will be systematically collected. Patients will be followed at monthly intervals for a minimum of 12 months for the primary endpoint of stroke in the vertebrobasilar territory. PUBLIC HEALTH RELEVANCE: By defining the population of patients at highest risk of recurrent stroke, this study will significantly impact the selection criteria and likelihood for success of future clinical trials aimed at assessing interventions for the treatment of vertebrobasilar disease. Additionally, the ability to define a low risk population in whom the risks of expensive invasive interventions would be unnecessary will have an equally important impact from a public health, and health care cost, perspective.

描述（由申请人提供）：每年遭受的700,000杆中的三分之一超过三分之一发生在后循环中，这是动脉粥样硬化的脊椎动物闭塞性疾病的主要原因。有症状的椎体脂肪疾病每年的中风风险很高，平均每年10-15％。血管内血管成形术和支架的进展创造了新的治疗选择，但是这些干预措施具有很大的风险，并且确定适当候选者的选择标准仍然不确定。在进行昂贵的大规模随机试验的干预试验之前，有必要定义最有可能受益于治疗的适当高风险人群。这项研究的总体目的是定义脊髓脂肪疾病患者的人群，重复中风风险最高。结果将有好准备，为未来的血管内或外科干预的临床试验构成基础。初步回顾性数据表明，椎体射击疾病中的中风风险与颅内血流损害密切相关，颅内血流可以使用定量磁共振血管造影（QMRA）进行非侵入性测量。目的是对症状性血管造影证实的脊椎狭窄（E 50％）的患者进行前瞻性多中心观察研究，以检验那些证明血液流量受损的人处于较高的中风风险。入学后，受试者将对脊椎动物领域中的QMRA进行血液动力学评估，以评估大血管流量，并评估MR灌注以评估组织水平灌注。根据现有的初步数据，将被指定为前瞻性指定为证明受损或正常的大脑流动；结果将使医生和患者视而不见。基线临床，实验室和流行病学数据将系统收集。在椎体面积的中风的主要终点，每月将每月遵循至少12个月的患者。公共卫生相关性：通过定义重复中风的最高风险的患者人群，这项研究将显着影响旨在评估治疗椎体脂肪疾病的干预措施的未来临床试验的选择标准和可能性。此外，定义低风险人群的能力将不必要地从公共卫生和医疗保健成本（观点）产生同样重要的影响。