PERIODONTAL INTERVENTION FOR CARDIAC EVENTS: PILOT TRIAL

心脏事件的周期干预：试点试验

• 批准号: 6658170
• 负责人: Robert J Genco
• 金额: $ 253.83万
• 依托单位: STATE UNIVERSITY OF NEW YORK AT BUFFALO
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-07-15 至 2006-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6658170
• 关键词: antimicroorganism antibody; azithromycin; cardiovascular disorder; cardiovascular disorder chemotherapy; cardiovascular disorder prevention; clinical research; data management; dental disorder chemotherapy; dental plaque; disease /disorder proneness /risk; human subject; human therapy evaluation; iatrogenic disease; interview; longitudinal human study; outcomes research; periodontium disorder; questionnaires; therapy compliance

DESCRIPTION: (abstract verbatim) This proposal is to develop the clinical trial organization for studies of periodontal treatment in the secondary prevention of cardiovascular events and to develop the institutional teams to accomplish the research. With the appropriate infrastructure and procedures developed, a future definitive randomized clinical trial of the relationship between periodontal infection and cardiovascular disease can be successfully carried out. There is growing evidence of a strong relationship between infection and atherosclerosis as well as a specific link between periodontal infection and heart disease. Previous studies have established possible effective treatments of periodontal disease. These treatments may lead to a diminution of subsequent occurrence of myocardial events in persons at high risk for cardiovascular disease. A clinical trial process to demonstrate the feasibility of a periodontal intervention trial in heart patients requires the establishment of a new team of cardiologists, periodontists, epidemiologists, infectious disease specialists, biostatisticians, research nurses in periodontics and cardiology, and data managers. In addition, such a study requires a large number of institutional investigative centers. In contrast to previous heart disease studies, the primary treatment in the new trial process would be directed toward infectious agents with specific attention to periodontal sites. We propose a multi-center Planning and Pilot Study involving 5 Investigational Centers at the University of Buffalo, University of North Carolina, Boston University, Kaiser Permanente/Oregon Health Science University, University of Maryland, and a Coordinating Center at the University of North Carolina. This study will be supported by Central Microbiology and Cytokine Labs, and a Biologic Specimen Bank. The establishment of the investigative machinery to determine the relationships and treatments linking infection, periodontal disease and heart disease requires a careful, cost-effective approach. This planning proposal outlines a process designed to develop and demonstrate the procedures for such studies, to conduct a pilot randomized clinical trial to test the feasibility of these procedures, and to select and refine a periodontal intervention. We propose that this planning and pilot study will ultimately lead to a definitive randomized clinical trial of the relationship between periodontal infection and cardiovascular disease, and may be a vanguard study for such a trial.

描述：（逐字摘要）本提案旨在开展临床试验 牙周病二级预防治疗研究组织 心血管事件，并发展机构团队，以实现 研究随着适当的基础设施和程序的发展， 未来确定性随机临床试验， 牙周感染和心血管疾病可以成功地进行 出去越来越多的证据表明，感染与 动脉粥样硬化以及牙周感染和 心脏病以前的研究已经建立了可能的有效治疗方法 牙周病的症状这些治疗可能会减少随后的 心血管疾病高危人群中心肌事件的发生率 疾病一个临床试验过程，以证明一个 心脏病患者的牙周干预试验需要建立 一个由心脏病学家、牙周病学家、流行病学家、传染病学家 牙周病学和心脏病学的专家、生物统计学家、研究护士， 数据管理员。此外，这样的研究需要大量的 机构调查中心。与以前的心脏病相比 研究，新试验过程中的主要治疗将被导向 特别注意牙周部位的感染因子。我们 提出一项多中心计划和初步研究，涉及5项试验性研究 布法罗大学、北卡罗来纳州大学、波士顿大学中心 University，Kaiser Permanente/俄勒冈州健康科学大学 马里兰州，以及北卡罗来纳州大学的协调中心。这 这项研究将得到中央微生物学和细胞因子实验室的支持， 生物标本库。建立调查机制， 确定关系和治疗链接感染，牙周 疾病和心脏病需要一个谨慎的，具有成本效益的方法。这 规划建议概述了一个旨在开发和展示 这些研究的程序，进行试点随机临床试验， 测试这些程序的可行性，并选择和完善一个 牙周干预我们建议这项规划和试验研究， 最终导致一个明确的随机临床试验的关系， 牙周感染和心血管疾病之间的联系， 为这样的审判而学习。