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）：每年发生的 700,000 起中风中，有超过三分之一发生在后循环，其主要原因是动脉粥样硬化性椎基底动脉闭塞性疾病。有症状的椎基底动脉疾病每年带来很高的中风风险，平均每年为 10-15%。血管内血管成形术和支架置入术的进步创造了新的治疗选择，但这些干预措施具有巨大的风险，并且确定合适候选人的选择标准仍然不确定。在开始昂贵的大规模随机干预试验之前，有必要确定最有可能从治疗中受益的适当高风险人群。本研究的总体目标是确定中风复发风险最高的椎基底动脉疾病患者群体。结果将为未来血管内或手术干预的临床试验奠定基础。初步回顾性数据表明，椎基底动脉疾病的中风风险与颅内血流受损密切相关，其程度可以使用定量磁共振血管造影（QMRA）进行无创测量。目的是对经血管造影证实有症状的椎基底动脉狭窄 (e 50%) 或闭塞的患者进行前瞻性多中心观察性研究，以检验血流受损的患者中风风险较高的假设。入组后，受试者将接受血流动力学评估，使用 QMRA 评估大血管流量，并使用 MR 灌注评估椎基底动脉区域的组织水平灌注。根据现有的初步数据，受试者将被前瞻性地指定为脑血流受损或正常的受试者；治疗医生和患者将无法得知结果。将系统地收集基线临床、实验室和流行病学数据。将每月对患者进行一次至少 12 个月的随访，以了解椎基底动脉区域中风的主要终点。公共健康相关性：通过确定复发性中风风险最高的患者群体，本研究将显着影响未来旨在评估椎基底动脉疾病治疗干预措施的临床试验的选择标准和成功的可能性。此外，从公共卫生和医疗保健成本的角度来看，定义低风险人群的能力将产生同样重要的影响，在这些人群中，昂贵的侵入性干预措施的风险是不必要的。