ACTION TO CONTROL CARDIOVASCULAR RISK IN DIABETES FOLLOW-ON (ACCORDION) STUDY- C

控制糖尿病心血管风险的行动后续（手风琴）研究 - C

• 批准号: 8428986
• 负责人: ROBERT BYINGTON
• 金额: $ 52.95万
• 依托单位: WAKE FOREST UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-01-01 至 2013-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8428986
• 关键词: Address; Adopted; Advisory Committees; Affect; Age; Aging; Agreement; Amendment; Ancillary Study; Biological; Brain; Cardiovascular Diseases; Cerebrum; Clinical; Clinical Trials; Cognition; Computer Systems; Computer software; Computers; Confidentiality; Consent Forms; Contractor; Contracts; Data; Data Analyses; Data Collection; Databases; Development; Diabetes Mellitus; Diabetic Angiopathies; Documentation; Effectiveness of Interventions; Electrocardiogram; Elements; Enrollment; Ensure; Ethics; Event; Failure; Funding; Future; Human Subject Research; Impairment; Institutional Review Boards; Intervention; Investigation; Laboratories; Leadership; Legal; Longitudinal Studies; Maintenance; Manuals; Measures; Mediation; Methodology; Modeling; National Heart, Lung, and Blood Institute; Non-Insulin-Dependent Diabetes Mellitus; Online Systems; Outcome; Participant; Pathology; Pattern; Phase; Procedures; Protocols documentation; Publications; Quality Control; Reading; Records; Rehabilitation therapy; Reporting; Safety; Secure; Security; Site; Specimen; Structure; System; Testing; Time; Update; Visit; Writing; cardiovascular risk factor; clinical research site; cohort; cost effectiveness; design; follow-up; meetings; member; mortality; repository; web page; web site; working group

This contract is for the post-trial observational follow-up study after termination of study-assigned interventions in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) clinical trial. The new ACCORD Follow-on (ACCORDION) Main Study will determine whether any differences seen during ACCORD in mortality, cardiovascular disease (CVD) events, and microvascular diseases persist or change over time and whether other differences emerge. In addition, the follow-up will examine patterns of key clinical variables, including safety parameters, and their association with clinical events. Under ACCORDION, follow-on sub-studies conducted under the ACCORD trial will be continued. Specifically, the aim of the ACCORDION-MIND Cognition follow-on sub-study is to further delineate how intensive therapy for type 2 diabetes affects brain function. In particular, the data from this follow-up will more closely examine whether and how observed changes in brain structure ultimately impact ongoing decline in CF. The aging of the cohort, longer follow-up and repeated measures of CF will also allow the study of longitudinal effects of diabetes-related factors on the brain, and the investigation of how these factors, in combination with older age, interact, leading to worse outcomes. The substudy will also focus on how impairment in CF prospectively affects the course of diabetes, and identify factors that may propagate, or mitigate, development of cerebral pathology. The aim of the ACCORDION-HRQL follow-on sub-study is to determine the long-term cost-effectiveness of the interventions that were tested in the ACCORD study.

该合同是针对终止研究分配的干预措施以控制糖尿病（ACCORC）临床试验的心血管风险的干预措施后的试验后观察随访研究。新的协定后续研究（手风琴）主要研究将确定死亡率，心血管疾病（CVD）事件中的任何差异和微血管疾病是否持续或随着时间的流逝以及其他差异是否出现。此外，随访将检查关键临床变量的模式，包括安全参数及其与临床事件的关联。 根据手风琴，将继续根据协定审判进行的后续小组。具体而言，手风琴认知后续研究的目的是进一步描述2型糖尿病的强化疗法如何影响大脑功能。特别是，此随访的数据将更加仔细地研究大脑结构的观察到的变化以及如何最终影响CF的持续下降。队列的衰老，更长的随访和重复测量CF还将允许研究与糖尿病相关因素对大脑的纵向作用，以及对这些因素与老年人相互作用的结合的研究，从而导致较差的结果。该物质还将集中于CF中前瞻性影响糖尿病病程的损害，并确定可能传播或减轻脑病理发展的因素。手风琴HRQL后续研究的目的是确定协议研究中测试的干预措施的长期成本效益。