Balancing the Risks of Ischemia and Bleeding in Percutaneous Coronary Interventio

平衡经皮冠状动脉介入治疗中的缺血和出血风险

基本信息

批准号：
8724553
负责人：
Robert Yeh
金额：
$ 13.72万
依托单位：
MASSACHUSETTS GENERAL HOSPITAL
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：
2013-09-01 至 2018-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8724553
关键词：
Accounting Adverse event Age Antiplatelet Drugs Applications Grants Area Benefits and Risks Bioinformatics Blood Platelets Cardiac Catheterization Procedures Cardiology Cardiovascular system Catheterization Clinical Clinical Investigator Clinical Research Clinical Trials Coagulation Process Computer software Conduct Clinical Trials Coronary Coronary Arteriosclerosis Coronary artery Data Data Analyses Decision Aid Decision Analysis Economics Effectiveness Electronic Health Record Environment Epidemiology Equilibrium Ethnic group Event Faculty Feasibility Studies Funding General Hospitals Goals Health Health Policy Heart Hemorrhage Individual Industry Information Technology Institution Insurance Internal Medicine Intervention Ischemia K-Series Research Career Programs Laboratories Lead Literature Logistic Regressions London Manuals Massachusetts Medical Medicine Mentors Methods Modeling Morbidity - disease rate Natural Language Processing Outcome Outcomes Research Patient Care Patient-Focused Outcomes Patients Persons Pharmaceutical Preparations Physicians Population Population Study Procedures Randomized Randomized Clinical Trials Registries Relative (related person)Reporting Research Research Institute Research Methodology Research Personnel Research Training Resources Risk Safety Schools System Testing Time Training Training Programs Translating Uncertainty United States National Institutes of Health Variant Weight alternative treatment career career development clinical decision-making cohort comparative effectiveness coronary angioplasty design effectiveness research experience implementation research improved innovation interest medical schools meetings member mortality new technology novel patient oriented patient population patient registry percutaneous coronary intervention point of care population health professor prospective public health relevance racial and ethnic routine care routine practice skills symposium theories tool treatment effect treatment strategy usability

项目摘要

DESCRIPTION (provided by applicant): The overall objective of this grant proposal is to develop and assess a system to enhance the rational and personalized application of antiplatelet therapy for patients undergoing percutaneous coronary intervention (PCI, or coronary angioplasty and stenting). This proposal describes a 5 year research and training program designed to provide the candidate, Robert Yeh, the necessary skills and experience to develop an independent academic research career in the conduct of translational cardiovascular outcomes research. Candidate: Dr. Yeh received an MSc in health policy from the London School of Economics, an MD from Harvard Medical School, and has completed clinical training in internal medicine (MGH), cardiology (UCSF) and interventional cardiology (MGH). He is now a junior faculty member at the Massachusetts General Hospital with 75% protected time to conduct clinical research. While he has successfully been involved with epidemiologic and secondary data analysis, Dr. Yeh will pursue additional training in the areas of decision analysis, clinical trial conduct and implementation research, and bioinformatics - training which will allow him to translate outcomes research findings into novel interventions which improve patient health. The candidate's long-term goal is to become an R01-funded investigator in the applied outcomes research that has a broad impact on population health. Environment: The candidate will be mentored by Dr. Laura Mauri (Primary Mentor), Associate Professor of Medicine at HMS and chief scientific officer of the Harvard Clinical Research Institute (HCRI), and Dr. Sharon- Lise Normand (Co-Mentor), Professor of Health Care Policy at HMS and Vice Chair of the Patient-Centered Outcomes Research Institute's Methods Committee. Both are internationally recognized leaders in their respective fields, and provide complementary expertise relevant to the research and training of the candidate. Dr. Mauri has an established track record of successfully leading practice-changing multicenter clinical trials in interventional cardiology, including the NIH/FDA/Industry-sponsored Dual Antiplatelet Theray (DAPT) Study. She has mentored several cardiovascular clinical investigators, including those that have received K awards and R01 funding. Dr. Normand has successfully mentored a large number of successful academic investigators, and is an internationally recognized expert in outcomes and comparative effectiveness research methods used in this proposal. The combined resources of several Harvard Medical School institutions, including HCRI, the Department of Health Care Policy, and the MGH Heart Center will support a rich and productive environment for Dr. Yeh's career development through a combination of didactic training, seminars, weekly research meetings, and conference presentations. Research: In the current era of invasive management of coronary artery disease, balancing the tradeoff between ischemic events and bleeding complications has become integral to decisions regarding the type and duration of antiplatelet therapy in patients undergoing coronary intervention. In Aim 1, multivariable logistic regression will be used to develop models that can predict bleeding and ischemic events in patients after PCI depending on antiplatelet strategy, using data from the DAPT Study, the largest PCI clinical trial conducted to date, and the Massachusetts PCI Registry, a comprehensive longitudinal registry of patients undergoing coronary intervention. Models that can predict treatment benefit or harm associated with specific strategies will be developed. In Aim 2, decision analysis methods will be employed to enhance these models such that the treatment strategy which is predicted to maximize patient benefit can be identified for all patients, and associated uncertainty in this determination can be assessed. In Aim 3, these tools will be integrated into a novel software application that can execute multivariable risk predictions at the point of care within the MGH cardiac catheterization laboratory. These tools will be used as clinical decision aids, and tested in a prospective randomized clinical trial to determine whether such interventions can enhance clinical decision making. The research will demonstrate how the end products of outcomes research can be translated into innovative interventions that can "personalize" medical decisions and ultimately improve patient care.

描述（由申请人提供）：该赠款提案的总体目标是开发和评估一种系统，以增强对接受经皮冠状动脉干预（PCI或冠状动脉血管成形术和支架）患者的抗血小板治疗的合理和个性化应用。该建议描述了一项为期5年的研究和培训计划，旨在为候选人罗伯特·耶（Robert Yeh）提供必要的技能和经验，以开发转化心血管成果研究的独立学术研究生涯。候选人：YEH博士获得了伦敦经济学院的卫生政策硕士学位，哈佛医学院的医学博士，并完成了内科（MGH），心脏病学（UCSF）和介入心脏病学（MGH）的临床培训。现在，他是马萨诸塞州综合医院的初级教职员工，有75％的保护时间进行临床研究。尽管他成功地参与了流行病学和二级数据分析，但YEH博士将在决策分析领域进行其他培训，临床试验和实施研究以及生物信息学 - 培训将使他能够将研究结果转化为改善患者健康的新干预措施。候选人的长期目标是成为R01资助的研究者，在对人口健康产生广泛影响的应用结果研究中。环境：候选人将由HMS医学副教授Laura Mauri博士，哈佛大学临床研究所（HCRI）的首席科学官以及HMS卫生保健政策教授兼患者居住在患者居住的研究所的研究所委员会委员会的Sharon-Sharon-Normand（合作者）。两者都是各自领域的国际认可的领导者，并提供与候选人的研究和培训有关的补充专业知识。毛里博士在介入心脏病学领域成功领先实践的多中心临床试验（包括NIH/FDA/行业赞助的双重抗血小板Turnay（DAPT）研究）的既定记录。她指导了几位心血管临床研究人员，包括获得K奖和R01资金的临床研究人员。诺曼德博士已成功指导了大量成功的学术研究人员，并且是该提案中使用的结果和比较有效性研究方法的国际认可的专家。包括HCRI，卫生保健政策部和MGH心脏中心在内的几个哈佛医学院机构的综合资源将通过教学培训，研讨会，每周研究会议和会议演讲的结合，为YEH博士的职业发展提供丰富而富有成效的环境。研究：在当前对冠状动脉疾病的侵入性管理时代，平衡缺血事件和出血并发症之间的权衡取平衡，这对于接受冠状动脉干预的患者的抗血小板治疗的类型和持续时间的决定已经成为不可或缺的一部分。在AIM 1中，使用DAPT研究中的数据，迄今为止进行的最大的PCI临床试验，以及Massachusetts PCI注册表，一项全面的较长的患者持续性较长的患者。将开发可以预测与特定策略相关的治疗益处或危害的模型。在AIM 2中，将采用决策分析方法来增强这些模型，从而为所有患者确定可预测的治疗策略，并且可以评估该决定中的相关不确定性。在AIM 3中，这些工具将集成到新的软件应用程序中，该应用程序可以在MGH心脏导管实验室内的护理点执行多变量的风险预测。这些工具将用作临床决策辅助工具，并在一项前瞻性随机临床试验中进行测试，以确定此类干预措施是否可以增强临床决策。该研究将证明如何将结果研究的最终产品转化为创新的干预措施，这些干预措施可以“个性化”医疗决策并最终改善患者护理。