Preclinical Consortium to Facilitate Translation of Cardioprotective Therapies
临床前联盟促进心脏保护疗法的转化
基本信息
- 批准号:8316321
- 负责人:
- 金额:$ 219.7万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2010
- 资助国家:美国
- 起止时间:2010-08-01 至 2015-07-31
- 项目状态:已结题
- 来源:
- 关键词:AcademiaAcute myocardial infarctionAddressAmericanAmericasAnimal ModelBasic ScienceBiological MarkersBlast CellBlindedCarbon MonoxideCause of DeathCessation of lifeClinicalClinical TrialsClinical Trials NetworkCommunitiesComorbidityConsciousDoctor of MedicineDoseEducational workshopElectronic MailEnsureEvaluationExperimental ModelsFailureFamily suidaeFundingFutureGoalsHealthcareHistologyIndividualIndustryInfarctionInstitutionInterventionInvestmentsIschemic PreconditioningJournalsLaboratoriesLettersLogisticsMindMissionModelingMorbidity - disease rateMusMyocardial InfarctionMyocardial IschemiaMyocardial tissueNational Heart, Lung, and Blood InstituteOryctolagus cuniculusParticipantPatientsPhasePlasmaPre-Clinical ModelProbabilityProtocols documentationPublic HealthPublishingRandomizedRecommendationReperfusion TherapyReportingReproducibilityResearchResearch InfrastructureResearch PersonnelResource SharingResourcesReview CommitteeRoleScreening procedureSodium NitriteStatistical Data InterpretationStatistical MethodsStructureSystemTestingTherapeutic InterventionTimeTranslatingTranslational ResearchTranslationsUnited States National Institutes of HealthWorkabstractingclinical applicationdesigndisabilityinterestmeetingsmembermortalitymyocardial infarct sizingnovel strategiesoperationoutcome forecastpre-clinicalpre-clinical researchpreclinical evaluationpreclinical studyprogramsresearch studyresponsesildenafilsuccessweb siteworking group
项目摘要
DESCRIPTION (provided by applicant):
Ischemic heart disease causes -600,000 deaths/year (-20% of all deaths). An estimated 1.3 million Americans have a myocardial infarction every year; because their prognosis is determined by the size of the infarct, reducing infarct size is of paramount importance to alleviate morbidity and mortality. For more than 30 years the NHLBI has invested enormous resources (at least several hundred million dollars) in preclinical studies aimed at developing infarct-sparing therapies, and several hundred (if not thousands) therapies have been claimed to limit infarct size in preclinical models. Unfortunately, due to methodological problems, this enormous investment has not produced any notable clinical application, and no cardioprotective therapy is currently available for clinical use. After >30 years of futile efforts, a new approach is needed to overcome the problems that have impeded the translation of cardioprotective therapies. The time has come to apply to preclinical research the same standards of scientific rigor that are applied to clinical trials. Using the clinical trials networks established by the NHLBI as a model for developing a collaborative infrastructure for research sharing, we propose a preclinical consortium that will operate in a manner analogous to a clinical network. Six Institutions will work together to conduct blinded, randomized, and adequately powered studies using a rigorous design, full dose-response analyses, optimal statistical methods, independent data analysis and statistical Cores, histology, plasma biomarkers, and relevant animal models (including conscious animals and models of comorbidities) in three species (mouse, rabbit, pig). To ensure reproducibilitv. each study will be performed in two Centers using identical protocols. This unique infrastructure will enable rigorous preclinical evaluation of promising cardioprotective therapies and will serve the entire scientific community (both in academia and in biomedical industry), thereby constituting a public resource. Proposals for studying therapies will be solicited from the entire scientific community and reviewed by an independent Protocol Review Committee, which will select those that will be implemented. At least 3 therapies/year will be tested. The consortium structure will ensure that it will be a true public resource available to all interested investigators and that all proposed studies will be evaluated in an equitable fashion. The need for this infrastructure is attested to by 30 letters (Appendix). This will be a paradigm shift in cardioprotection. By screening promising therapies and identifying those that are reproduciblv effective in relevant experimental models and, thus, most likely to be effective in patients, the consortium will dramatically advance our ability to rationally translate basic findings into clinical use.
This proposal addresses an issue that has major importance for the NHLBI mission and for public health at large, namely, the failure to translate experimental studies of cardioprotection into clinical therapies. Ischemic heart disease is the number one cause of death and disability in America. Since ~1.3 million Americans have a myocardial infarction each year and their prognosis is determined by the size of the infarct, reducing infarct size will have a major impact on their morbidity and mortality and, thus, enormous implications for public health. (End of Abstract)
描述(由申请人提供):
缺血性心脏病每年导致约600,000人死亡(约占所有死亡人数的20%)。据估计,每年有130万美国人患有心肌梗死;因为他们的预后取决于梗死的大小,所以减少梗死面积对于降低发病率和死亡率至关重要。30多年来,NHLBI在临床前研究中投入了大量资源(至少数亿美元),旨在开发梗死保留疗法,并且已经声称有数百种(如果不是数千种)疗法可以限制临床前模型中的梗死面积。不幸的是,由于方法学问题,这种巨大的投资没有产生任何显著的临床应用,并且目前没有心脏保护疗法可用于临床。经过超过30年的徒劳努力,需要一种新的方法来克服阻碍心脏保护疗法转化的问题。现在是时候将适用于临床试验的科学严谨性标准应用于临床前研究了。利用NHLBI建立的临床试验网络作为开发研究共享协作基础设施的模型,我们提出了一个临床前联盟,该联盟将以类似于临床网络的方式运作。六家机构将共同开展设盲、随机化和充分把握度的研究,采用严格的设计、完整的剂量-反应分析、最佳统计方法、独立的数据分析和统计核心、组织学、血浆生物标志物和相关动物模型(包括清醒动物和合并症模型),在三个种属(小鼠、兔、猪)中开展研究。确保可重复性。每项研究将在两个中心使用相同的方案进行。这种独特的基础设施将使有前途的心脏保护疗法的严格临床前评估成为可能,并将服务于整个科学界(学术界和生物医学行业),从而构成公共资源。研究疗法的建议将从整个科学界征求,并由一个独立的方案审查委员会审查,该委员会将选择那些将被实施的方案。每年至少测试3种治疗。联合体的结构将确保它将成为所有感兴趣的研究人员可以利用的真正的公共资源,并确保所有拟议的研究将以公平的方式进行评估。30封信证明了对这一基础设施的需要(附录)。这将是心脏保护的范式转变。通过筛选有前景的疗法,并确定那些在相关实验模型中可重复有效的疗法,从而最有可能对患者有效,该联盟将大大提高我们将基本发现合理转化为临床应用的能力。
该提案涉及一个对NHLBI使命和广大公众健康具有重大意义的问题,即未能将心脏保护的实验研究转化为临床治疗。缺血性心脏病是美国死亡和残疾的头号原因。由于每年约有130万美国人患有心肌梗死,并且他们的预后取决于梗死的大小,因此减少梗死面积将对他们的发病率和死亡率产生重大影响,从而对公共卫生产生巨大影响。(End摘要)
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Roberto Bolli其他文献
Roberto Bolli的其他文献
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{{ truncateString('Roberto Bolli', 18)}}的其他基金
University of Louisville Regional Clinical Center for the CCTRN
路易斯维尔大学 CCTRN 区域临床中心
- 批准号:
8448108 - 财政年份:2012
- 资助金额:
$ 219.7万 - 项目类别:
University of Louisville Regional Clinical Center for the CCTRN
路易斯维尔大学 CCTRN 区域临床中心
- 批准号:
8288932 - 财政年份:2012
- 资助金额:
$ 219.7万 - 项目类别:
University of Louisville Regional Clinical Center for the CCTRN
路易斯维尔大学 CCTRN 区域临床中心
- 批准号:
9437819 - 财政年份:2012
- 资助金额:
$ 219.7万 - 项目类别:
University of Louisville Regional Clinical Center for the CCTRN
路易斯维尔大学 CCTRN 区域临床中心
- 批准号:
9230424 - 财政年份:2012
- 资助金额:
$ 219.7万 - 项目类别:
University of Louisville Regional Clinical Center for the CCTRN
路易斯维尔大学 CCTRN 区域临床中心
- 批准号:
8628874 - 财政年份:2012
- 资助金额:
$ 219.7万 - 项目类别:
Preclinical Consortium to Facilitate Translation of Cardioprotective Therapies
临床前联盟促进心脏保护疗法的转化
- 批准号:
8714025 - 财政年份:2010
- 资助金额:
$ 219.7万 - 项目类别:
Preclinical Consortium to Facilitate Translation of Cardioprotective Therapies
临床前联盟促进心脏保护疗法的转化
- 批准号:
8119121 - 财政年份:2010
- 资助金额:
$ 219.7万 - 项目类别:
Preclinical Consortium to Facilitate Translation of Cardioprotective Therapies
临床前联盟促进心脏保护疗法的转化
- 批准号:
7569072 - 财政年份:2010
- 资助金额:
$ 219.7万 - 项目类别:
Preclinical Consortium to Facilitate Translation of Cardioprotective Therapies
临床前联盟促进心脏保护疗法的转化
- 批准号:
8519517 - 财政年份:2010
- 资助金额:
$ 219.7万 - 项目类别:
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