CAPTIVA-MRI

基本信息

批准号：
10578494
负责人：
Sepideh Amin-Hanjani
金额：
$ 190.66万
依托单位：
YALE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-04-15 至 2024-12-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10578494
关键词：
Address Affect African American population Age American Ancillary Study Angioplasty Antibody Therapy Arterial Fatty Streak Arteries Asian population Aspirin Biological Markers Black Populations Blood Vessels Blood flow Brain Carotid Atherosclerotic Disease Carotid Stenosis Cerebrovascular system Coronary Arteriosclerosis Data Data Set Distal Ensure Ethnic Origin Event Failure Future Hispanic Populations Image Impairment Individual Infarction Infrastructure Intervention Investments Ischemic Stroke Knowledge Liquid substance MRI Scans Magnetic Resonance Imaging Measurement Measures Medical Methods Modeling Monoclonal Antibodies Operative Surgical Procedures Outcome Parents Participant Patient Selection Patients Phase Public Health Qualifying Race Randomized Recurrence Reporting Research Research Personnel Resistance Resources Risk Risk Factors Standardization Stenosis Stents Stroke Stroke prevention Subgroup System Techniques Time Visit Visualization White Matter Hyperintensity Work adjudication cerebrovascular clopidogrel disability effective therapy follow-up hemodynamics high risk imaging biomarker imaging study improved indexing lifestyle intervention magnetic resonance imaging biomarker multimodality next generation novel novel therapeutic intervention precision medicine prevent primary outcome prospective risk stratification secondary analysis secondary outcome sex shear stress standard of care stroke event three-arm trial treatment arm trial design vascular risk factor

Address Affect African American population Age American Ancillary Study Angioplasty Antibody Therapy Arterial Fatty Streak Arteries Asian population Aspirin Biological Markers Black Populations Blood Vessels Blood flow Brain Carotid Atherosclerotic Disease Carotid Stenosis Cerebrovascular system Coronary Arteriosclerosis Data Data Set Distal Ensure Ethnic Origin Event Failure Future Hispanic Populations Image Impairment Individual Infarction Infrastructure Intervention Investments Ischemic Stroke Knowledge Liquid substance MRI Scans Magnetic Resonance Imaging Measurement Measures Medical Methods Modeling Monoclonal Antibodies Operative Surgical Procedures Outcome Parents Participant Patient Selection Patients Phase Public Health Qualifying Race Randomized Recurrence Reporting Research Research Personnel Resistance Resources Risk Risk Factors Standardization Stenosis Stents Stroke Stroke prevention Subgroup System Techniques Time Visit Visualization White Matter Hyperintensity Work adjudication cerebrovascular clopidogrel disability effective therapy follow-up hemodynamics high risk imaging biomarker imaging study improved indexing lifestyle intervention magnetic resonance imaging biomarker multimodality next generation novel novel therapeutic intervention precision medicine prevent primary outcome prospective risk stratification secondary analysis secondary outcome sex shear stress standard of care stroke event three-arm trial treatment arm trial design vascular risk factor

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项目摘要

PROJECT SUMMARY/ABSTRACT ABSTRACT Intracranial atherosclerotic stenosis (ICAS) is the most common cause of ischemic stroke in the world and continues to have the highest rate of stroke recurrence (>15% of patients in the first year). In comparison, carotid stenosis has a first-year stroke recurrence rate of <5% of patients, but the medical and surgical treatments that work for carotid stenosis are not as successful for ICAS. We propose that the failure to prevent ICAS stroke recurrence reflects that percentage stenosis alone is not the optimal approach to risk stratification, and that focusing on functional blood flow and the ICAS plaque itself will add critical information. Using MRI, we have shown that hemodynamic impairment and disruption caused by ICAS, measured with phase-contrast quantitative MRA and computational fluid dynamic wall shear stress, is correlated with the risk of recurrent stroke. We have also found an association between ICAS plaque enhancement on vessel wall MRI and recurrent ischemic stroke. To further explore our paradigm shifting approach of advanced MRI measurement of ICAS hemodynamic and plaque biomarkers, we will conduct an ancillary imaging study to CAPTIVA, a 3-arm trial of patients with symptomatic ICAS causing 70-99% stenosis randomly assigned to aspirin plus ticagrelor, rivaroxaban, or clopidogrel. Our ancillary study, CAPTIVA-MRI, will establish if there are MRI biomarkers that can identify ICAS patients who fail best medical management and could identify precision medicine treatment approaches for ICAS patients. We will perform multimodal MRI imaging in a subgroup of 300 CAPTIVA patients at the baseline and the 1-year follow-up visit. After decades of focusing on stenosis, the proposed approach could change ICAS research, based on mechanistic understanding of how ICAS causes stroke. We have assembled a team with the required expertise for a prospective multicenter MRI study, including primary investigators of the VERiTAS and MyRIAD prospective multicenter MRI studies of ICAS. The parent trial, CAPTIVA, does not include standardized brain or vascular imaging, presenting a clear opportunity. The proposed study will provide vital and actionable data for future research and will answer critical questions about ICAS progression and provide valuable MRI data for a wide variety of important analyses in the CAPTIVA trial dataset.

项目摘要/摘要抽象的颅内动脉粥样硬化狭窄（ICAS）是世界上缺血性中风的最常见原因，并且中风复发率最高（第一年> 15％的患者）。相比之下，颈动脉狭窄的第一年中风复发率为<5％的患者，但是用于颈动脉狭窄的医学和外科手术治疗对ICAS而言并不那么成功。我们建议无法防止ICAS中风复发的重复反映出仅狭窄的百分比不是风险分层的最佳方法，并且专注于功能性血流和ICAS斑块本身将增加关键信息。使用MRI，我们已经表明，由ICAS引起的血液动力学障碍和破坏，该ICAS用相位对比度定量MRA和计算流体动态壁剪应力测量，与复发性中风的风险相关。我们还发现，在血管壁MRI上增强ICAS斑块与复发性缺血性中风之间的关联。为了进一步探索我们对ICAS血液动力学和斑块生物标志物进行高级MRI测量的范式转移方法，我们将向Captiva进行一项辅助成像研究，Captiva是一项症状性ICA的3 ARM试验，对症状性ICAS进行了70-99％的狭窄，导致stenosis随机分配给Apperailor plus ticagrelor Plus ticagrelor，Rivaroxaban和clopidogrogrogrogrogroxaban或clopidogrogrogrogrogrogrogrogrogrogrosel。我们的辅助研究Captiva-MRI将确定是否有MRI生物标志物可以识别出最佳医疗管理失败的ICAS患者，并且可以识别为ICAS患者的精确医学治疗方法。我们将在基线和为期1年的随访访问中在300名Captiva患者的子组中进行多模式MRI成像。经过数十年的关注狭窄，根据对ICAS引起中风的机理理解，提出的方法可以改变ICAS研究。我们已经组建了一个具有潜在多中心MRI研究所需的专业知识的团队，其中包括Veritas的主要研究人员和ICAS的无数潜在多中心MRI研究。父母试验Captiva不包括标准化的大脑或血管成像，提供明显的机会。拟议的研究将为未来的研究提供重要和可行的数据，并将回答有关ICAS进展的关键问题，并为Captiva试验数据集中的各种重要分析提供宝贵的MRI数据。