BARI II GRANT PROPOSAL FOR ECG CORE LABORATORY

BARI II 心电图核心实验室拨款提案

• 批准号: 6638513
• 负责人: Bernard R Chaitman
• 金额: $ 22.79万
• 依托单位: SAINT LOUIS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-09-15 至 2007-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6638513
• 关键词: angina pectoris; bioimaging /biomedical imaging; biomedical facility; blood glucose; clinical research; clinical trials; cooperative study; coronary bypass; diabetes mellitus therapy; electrocardiography; heart disorder chemotherapy; heart revascularization; human subject; human therapy evaluation; insulin sensitivity /resistance; myocardial ischemia /hypoxia; noninsulin dependent diabetes mellitus; patient oriented research

The revised Bypass Angioplasty Revascularization Investigation (BARI) II study proposes to evaluate treatments for Type 2 diabetic patients with angiographically proven coronary artery disease and stable angina or ischemia. For this rapidly growing patient population with very poor prognosis and quality of life, revascularization has been less beneficial than in nondiabetics. Using a factorial design, BARI II will compare revascularization combined with aggressive medical anti-ischemia treatment to aggressive medical anti-ischemia treatment alone; simultaneously, BARI II will compare two glycemic control strategies, insulin sensitization versus insulin provision. All patients will have target HbA1c values < 7.5%, and uniform control of hypertension, dyslipidemia and obesity following recommended guidelines. A total of 2,600 patients will be recruited, randomized, treated, and followed at 30 clinical centers. Five-year mortality will be the primary endpoint analyzed by intention-to-treat. The Coordinating Center (CC) will assume responsibility for overall trial operations including clinical site selection, data management using an Internet system, and statistical analysis. Within the CC will be operational units for the management of diabetes control, lipids and hypertension. Detailed data on potential mechanisms of macrovascular events will be collected with centralized evaluations of ECGs, lipids and HbA1c levels. A fibrinolysis core laboratory will explore the effect of glycemic control strategy on the progression and mechanism of vasculopathy, including changes in PAI-1 activity and gene expression. The investigators will evaluate the relative economic costs associated with revascularization approaches and diabetes control (Separate application for the ECG Core, the Fibrinolysis Core and the Economics Core complement this lead application). This 7-year application includes a 6-month protocol finalization phase, 2 years of patient recruitment and an additional 4.5 years of follow-up. BARI II aims to answer critical scientific questions regarding treatment efficacy in Type 2 diabetic patients with stable CAD. The investigators further expect that this collaborative effort will translate into a new practical clinical paradigm that will be used for treatment of Type II diabetic patients.

改良的旁路血管成形术血运重建研究（巴里）II研究 建议评估2型糖尿病患者的治疗方法， 血管造影证实的冠状动脉疾病和稳定型心绞痛或局部缺血。 对于这一快速增长的预后非常差的患者人群， 在生活质量方面，血运重建的益处不如 非糖尿病患者使用析因设计，巴里II将比较血运重建 结合积极的药物抗缺血治疗， 抗缺血治疗;同时，巴里II将比较两种 血糖控制策略，胰岛素增敏与胰岛素供应。 所有患者的目标HbA 1c值均<7.5%，并且HbA 1c的控制一致。 高血压、血脂异常和肥胖症。 总共将招募2，600名患者，进行随机化、治疗和随访 在30个临床中心 5年死亡率将是主要终点 协调中心（CC）将假设 负责总体试验操作，包括临床研究中心选择， 使用互联网系统进行数据管理和统计分析。 内 CC将成为糖尿病控制管理的业务单位， 血脂和高血压。 潜在机制的详细数据 将通过ECG的集中评价收集大血管事件， 血脂和HbA 1c水平。 纤溶核心实验室将探索 血糖控制策略对糖尿病进展及机制的影响 血管病变，包括派-1活性和基因表达的变化。 的 研究人员将评估与以下方面相关的相对经济成本： 血运重建方法和糖尿病控制（单独申请 ECG核心、纤溶核心和经济学核心补充了这一点 铅应用）。 这7年的应用程序包括6个月的协议 完成阶段，2年患者招募和额外4.5年 的后续行动。 巴里II旨在回答有关治疗的关键科学问题 2型糖尿病合并稳定型CAD患者的疗效。 调查人员 我还希望，这种合作努力将转化为一种新的 将用于治疗II型糖尿病的实用临床范例 糖尿病患者