KIDNEY DISEASE/HYPERTENSION IN AFRICAN AMERICANS--DCC

非裔美国人的肾脏疾病/高血压——DCC

• 批准号: 2734186
• 负责人: Michael Henry Kutner
• 金额: $ 180.8万
• 依托单位: CLEVELAND CLINIC FOUNDATION
• 依托单位国家: 美国
• 财政年份: 1994
• 资助国家: 美国
• 起止时间: 1994-08-15 至 2001-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2734186
• 关键词: ACE inhibitors; African American; antihypertensive agents; blood pressure; calcium channel blockers; cardiovascular disorder chemotherapy; chronic renal failure; clinical trials; cooperative study; data collection; glomerular filtration rate; health science research analysis /evaluation; human data; human therapy evaluation; information systems; kidney disorder diagnosis; renal hypertension; statistics /biometry

The Data Coordinating Center (DCC) for the African American Study of Kidney Disease and Hypertension (AASK) Full-Scale Trial will coordinate the scientific and operational aspects of the Study. This Study will examine the effectiveness of three stepped-care regimens in lowering blood pressure and two levels of blood pressure control in African Americans with hypertensive renal disease in order to slow the loss of kidney function as measured by glomerular filtration rate. In the transition months of the Recruitment Phase (Phase I), the DCC will review the Pilot Study data and protocol in conjunction with the Steering Committee to finalize the design of the Full-Scale Trial. Systems for data acquisition (via distributed data entry) and data management (using Oracle) will be established. A major activity of the DCC will be the development of procedures for control of the quality of the data. Review and finalization of the Manual of Operations and data forms will be done. The randomization schedule for entering patients will be generated. Central facilities at the Cleveland Clinic will be established for the measurement of renal function and biochemistry along with a Drug Distribution Center to coordinate the distribution of antihypertensive medications. The DCC will provide centralized training of Clinical Center staff in the areas of entry of study subjects, completion of study forms, use of the distributed data entry system and testing of renal function. The DCC will arrange meetings of the Steering Committee and participate in these meetings and report the proceedings. The database management system developed in Phase I will be used to assure accurate and complete collection of study data. A query system will be used to resolve data discrepancies. A major function of the DCC during the Recruitment Phase (Phase I) of the study will be to monitor patient recruitment and compliance as a whole and by Clinical Center. Study progress will be reported in monthly reports to the Clinical Centers, newsletters, and presentations at the Steering Committee, and Data and Safety Monitoring Board meetings. Statistical analyses will be performed during the course of the study with final analyses completed and reported during Phase III of the study. The DCC will develop new statistical methodology as needed to properly analyze the data being collected. Since the Study is a multi-centered effort including several organizational components, the DCC will be proactive in performing its duties so that the goals of the study are met. The DCC will work to foster a spirit of cooperation which is important in this multi-center study.

非裔美国人研究数据协调中心（DCC） 肾脏疾病和高血压（AASK）全规模试验将协调 研究的科学性和可操作性。本研究将 检查三种阶梯式护理方案在降低血液 非裔美国人的血压和两个水平的血压控制 高血压肾病患者，以减缓肾脏的损失 功能通过肾小球滤过率测量。 在招募阶段（第一阶段）的过渡月份，DCC将 结合指导审查初步研究数据和方案 该委员会负责完成全面试验的设计。数据系统 采集（通过分布式数据输入）和数据管理（使用 Oracle）将成立。发展协调委员会的一项主要活动是 制定控制数据质量的程序。审查 并将完成业务手册和数据表格的定稿。 将生成入组患者的随机化时间表。 克利夫兰诊所的中心设施将为 肾功能和生化沿着药物的测量 配送中心协调降压药的配送 药物治疗 DCC将提供临床中心的集中培训 在研究对象的输入领域的工作人员，完成研究表格， 使用分布式数据输入系统和检测肾功能。 发展协调委员会将安排指导委员会的会议，并参加 这些会议并报告会议情况。 第一阶段开发的数据库管理系统将用于确保 准确、完整地收集研究数据。查询系统将 用于解决数据差异。发展协调委员会在 研究的招募阶段（I期）将监测患者 招募和依从性作为一个整体，并由临床中心。 研究 将在每月报告中向临床中心报告进展情况， 通讯，并在指导委员会的介绍，以及数据和 安全监测委员会会议。将进行统计分析 在研究过程中完成并报告最终分析 在研究的第三阶段。DCC将开发新的统计数据 适当分析收集的数据所需的方法。 由于这项研究是一项多中心的工作， 组织的组成部分，DCC将积极主动地履行其 履行职责，以实现研究目标。DCC将努力促进 这种合作精神在这项多中心研究中很重要。