PERIODONTAL INTERVENTION FOR CARDIAC EVENTS: PILOT TRIAL

心脏事件的周期干预：试点试验

• 批准号: 6660458
• 负责人: Robert J Genco
• 金额: $ 4.77万
• 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 2004-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6660458
• 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)这项提议是为了发展临床试验 牙周治疗在二级预防中的研究组织 心血管事件和发展机构团队来完成 这项研究。在制定了适当的基础设施和程序后， 未来确定的随机临床试验的关系 牙周感染和心血管疾病可以成功携带 出去。越来越多的证据表明，感染和 以及牙周感染和动脉粥样硬化之间的特定联系。 心脏病。以前的研究已经确定了可能的有效治疗方法 牙周病。这些治疗可能会导致随后的 心血管疾病高危人群心肌事件的发生 疾病。一种临床试验过程，以证明一种 心脏病患者的牙周干预试验需要建立 一个由心脏病医生、牙周病医生、流行病学家、传染病专家组成的新团队 专家，生物统计学家，牙周病和心脏病学的研究护士， 和数据管理员。此外，这样的研究需要大量的 机构调查中心。与之前的心脏病不同 研究，新试验过程中的主要治疗将被指导 对感染性病原体要特别注意牙周部位。我们 提出多中心规划和试点研究，包括5项调查 布法罗大学、北卡罗来纳大学、波士顿大学 凯撒大学/俄勒冈健康科学大学 马里兰州，以及北卡罗来纳大学的协调中心。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，并将 生物标本库。设立调查机构，以 确定与感染、牙周的关系和治疗 疾病和心脏病需要一种谨慎、成本效益高的方法。这 规划建议书概述了旨在开发和演示 这类研究的程序，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，这项规划和试点研究将 最终导致一项明确的随机临床试验 牙周感染与心血管疾病之间的关系，并可能成为先锋 为这样的审判做准备。