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: 6390159
• 负责人: Bernard R Chaitman
• 金额: $ 25.19万
• 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/6390159
• 关键词: angina pectoris; bioimaging /biomedical imaging; biomedical facility; blood glucose; clinical research; 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

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.

改良旁路血管成形术血运重建调查(BARI)II研究 建议评估2型糖尿病患者的治疗方法 经血管造影证实的冠状动脉疾病和稳定型心绞痛或缺血。 对于这个迅速增长的患者群体来说，预后非常差， 生活质量，血管重建术的益处不如 非糖尿病患者。使用析因设计，BARI II将比较血运重建 结合积极的医疗抗缺血治疗到积极的医疗 单独进行抗缺血治疗；同时，BARI II将比较两种 血糖控制策略，胰岛素敏化与胰岛素供应。 所有患者都将有7.5%的目标HbA1c值，并统一控制 高血压、血脂异常和肥胖遵循推荐的指南。 总共2600名患者将被招募、随机、治疗和随访 在30个临床中心。五年死亡率将是主要终点 按意向治疗进行分析。协调中心(CC)将承担 负责包括临床选址在内的整体试运行； 使用互联网系统进行数据管理，并进行统计分析。在 CC将是管理糖尿病控制的业务单位， 血脂和高血压。关于潜在机制的详细数据 大血管事件将通过对ECG的集中评估来收集， 血脂和糖化血红蛋白水平。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PAI-1活性和基因表达的变化。这个 调查人员将评估与此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 心电核心、纤溶核心和经济学核心补充了这一点 牵头申请)。这份为期7年的申请包括为期6个月的协议 最终阶段，2年的患者招募和额外的4.5年 跟进的问题。 BARI II旨在回答有关治疗的关键科学问题 稳定冠心病的2型糖尿病患者的疗效。调查人员 进一步预计，这种合作努力将转化为一种新的 将用于II型治疗的实用临床范例 糖尿病患者。