MISTIE III: Cluster Application for the Data Coordinating Center

MISTIE III:数据协调中心集群应用

基本信息

  • 批准号:
    8730737
  • 负责人:
  • 金额:
    $ 65.1万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2013
  • 资助国家:
    美国
  • 起止时间:
    2013-09-15 至 2018-07-31
  • 项目状态:
    已结题

项目摘要

DESCRIPTION (provided by applicant): MISTIE III uniquely addresses the multiple unmet needs of both patients with intracerebral hemorrhage (ICH) and the research community. ICH impacts 100,000 Americans each year. Its incidence has remained unchanged over the last century and it remains a substantial public health problem that will only grow with our aging population. Prevention programs have not changed the ICH mortality rate or the long-term functional impairment that is greater than in ischemic stroke, with disastrous personal, social and economic consequences. Only 10% of ICH subjects return to functional independence. Interventions aimed at preventing ICH growth, brain protection, and open surgical evacuation has shown little or no significant impact on this dismal outcome. Consistent with the 2005 & 2012 NINDS priorities, MISTIE III will build on MISTIE II, a Phase II proof-of-concept trial that confirmed the feasibility and safety of minimally invasive surgery for thrombolytic clot evacuation (MIS+rt-PA). MISTIE II optimized the surgical task and demonstrated a dramatic effect on ICH volume reduction. Highlighted results include clinically important improvement in good functional outcomes at both 180 days (mRS 0-3) and 365 days (mRS 0-2) (11% & 14%, respectively), with a volume reduction effect more profound than any other strategies being tested in clinical trials. This treatment, more than any other trial, specifically applies to a larger volume of cases who currently suffer the worst outcomes. These results translate into decreased cost and increased patient utility, making this innovative therapy critically important to further investigate. Additionally, this Phase II trial demonstrated that our simple training protocol produced investigational-quality surgical performance and standardized volume-reduction results with basic surgeon training that will be widely generalizable. MISTIE III will confirm the central hypothesis that minimally invasive, catheter-based clot-size reduction is associated with clinically significant functional benefits in the long-term outcome of the ICH patient. Clinically and biologically, MISTIE III is a robust pathway applicable to other multiple molecular strategies that might further mitigate injury to brain tissue. Indications point to greater local cellular surival and improved long-term recovery corresponding to the well-established tissue and animal models. The MISTIE III network can accomplish these goals with demonstrated rigor and is ready to test the critical hypotheses regarding the generalizability and effectiveness of the MIS+rtPA procedure to improve outcome after ICH. - MISTIE III: Lead Grant-Cluster Application for the Clinical Coordinating Center
描述(由申请人提供):MISTIE III独特地解决了脑出血(ICH)患者和研究群体的多种未满足的需求。ICH每年影响10万美国人。它的发病率在上个世纪保持不变,它仍然是一个重大的公共卫生问题,只会随着我们人口的老龄化而增长。预防计划并未改变ICH的死亡率或长期功能损害,其大于缺血性卒中,并带来灾难性的个人、社会和经济后果。只有10%的ICH受试者恢复功能独立。旨在预防ICH生长、脑保护和开放性手术后送的干预措施对这种令人沮丧的结局几乎没有或没有显著影响。与2005年和2012年NINDS的优先事项一致,MISTIE III将建立在MISTIE II的基础上,MISTIE II是一项II期概念验证试验,证实了微创手术用于溶栓凝块清除的可行性和安全性 (MIS+rt-PA)。MISTIE II优化了手术任务,并证明了对ICH体积减少的显著效果。突出显示的结果包括在180天(mRS 0-3)和365天(mRS 0-2)(分别为11%和14%)时良好功能结局的临床重要改善,减容效果比临床试验中测试的任何其他策略更深刻。这种治疗比任何其他试验都更适用于目前遭受最差结果的大量病例。这些结果转化为降低的成本和增加的患者效用,使这种创新的治疗至关重要,以进一步研究。此外,该II期试验表明,我们的简单培训方案产生了调查质量的手术性能和标准化的减容结果,基本的外科医生培训将被广泛推广。MISTIE III将证实中心假设,即微创、基于导管的凝块尺寸减小与ICH患者长期结局的临床显著功能获益相关。在临床和生物学上,MISTIE III是一个强大的途径,适用于其他多分子策略,可能进一步减轻脑组织损伤。适应症指向更大的局部细胞存活率和改善的长期恢复,对应于良好建立的组织和动物模型。MISTIE III网络可以通过证明的严谨性实现这些目标,并准备好检验关于MIS+rtPA程序改善ICH后结局的普遍性和有效性的关键假设。- MISTIE III:临床协调中心的牵头基金-集群申请

项目成果

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Richard Thompson其他文献

Richard Thompson的其他文献

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{{ truncateString('Richard Thompson', 18)}}的其他基金

MISTIE III: Cluster Application for the Data Coordinating Center
MISTIE III:数据协调中心集群应用
  • 批准号:
    8578132
  • 财政年份:
    2013
  • 资助金额:
    $ 65.1万
  • 项目类别:
MISTIE III: Cluster Application for the Data Coordinating Center
MISTIE III:数据协调中心集群应用
  • 批准号:
    9108444
  • 财政年份:
    2013
  • 资助金额:
    $ 65.1万
  • 项目类别:
MISTIE III: Cluster Application for the Data Coordinating Center
MISTIE III:数据协调中心集群应用
  • 批准号:
    8895425
  • 财政年份:
    2013
  • 资助金额:
    $ 65.1万
  • 项目类别:

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