THROMBOLYSIS IN MYOCARDIAL ISCHEMIA-CORE APPLICATION

心肌缺血中的溶栓-核心应用

• 批准号: 3360622
• 负责人: EUGENE BRAUNWALD
• 金额: $ 80.07万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 1989
• 资助国家: 美国
• 起止时间: 1989-04-01 至 1992-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3360622
• 关键词: biomedical facility; clinical trials; diagnosis quality /standard; fibrinolytic therapy; heart disorder diagnosis; human subject; human therapy evaluation; myocardial ischemia /hypoxia

The applicants represent five experienced core laboratories which plan to provide centralized, blinded analysis of endpoints for the TIMI III study of patients with unstable angina and non-Q-wave MI. Details of the TIMI IIIA and IIIB protocols are contained in the accompanying Clinical, Application. The Quantitative Angiography Core Laboratory (TIMI IIIA) has already provided quantitative assessment of over 1,600 coronary angiogram in prior studies, including TIMI I and II. This laboratory will identify changes in coronary artery stenosis and flow following t-PA therapy. The ECG/ETT Core Laboratory (TIMI IIIA and IIIB) has extensive experience in the use of the Minnesota Code This laboratory will confirm that ECG entry criteria are met, verify that ischemic ECG changes occurred during attacks of pain, and provide standardized interpretation of ECGs recorded during the ETT. The Ambulatory ECG (AEOG) Monitoring Core Laboratory (TIMI IIIA and IIIB), has in operation an advanced computerized system for the analysis of ST-segment changes on ambulatory ECG monitoring. It will provide data on otherwise undetected ischemic episodes following therapy--changes that are associate with poor prognosis. The Qualitative Angiography Core Laboratories (TIMI IIIB) will ensure the quality of angiographic studies and of PTCA, and assess the angiographic response to therapy--functions it is currently performing for TIMI II. The Radionuclide (Thallium) Core Laboratory (TIMI IIISB), which has already served as a core laboratory for TIMI II, will ensure the quality of stress thallium studies in the clinical units and utilize specialized method of analysis which it has developed to quantitate the thallium defect. A substantial portion of its cost will be provide by industry. Thus, these five core laboratories will provide the specialized analyses required for assessment of the results of therapy in these acutely ill patients. A special strength of the application is the prior experience of each of the laboratories with the tasks they will perform in TIMI III.

申请者代表五个经验丰富的核心实验室， 计划提供集中的、设盲的终点分析， 不稳定型心绞痛和非Q波心肌梗死患者的TIMI III研究。 TIMI IIIA和IIIB方案的详细信息见 伴随临床应用。 定量血管造影核心实验室（TIMI IIIA） 已经提供了超过1,600例冠状动脉疾病的定量评估， 既往研究中的血管造影，包括TIMI I和II。 这 实验室将确定冠状动脉狭窄的变化， t-PA治疗后的血流。 ECG/ETT核心实验室（TIMI IIIA和IIIB）拥有广泛的 使用明尼苏达代码的经验，该实验室将 确认符合ECG入选标准，验证缺血性ECG 疼痛发作期间发生的变化，并提供标准化 对ETT期间记录的ECG进行解读。 动态心电图（AEOG）监测核心实验室（TIMI IIIA和 IIIB），已在运作一个先进的计算机化系统， 动态心电图ST段变化分析。 它 将提供其他未检测到的缺血发作的数据 这些变化与不良预后有关。 定性血管造影核心实验室（TIMI IIIB）将 确保血管造影研究和PTCA的质量，并评估 血管造影对治疗的反应--目前 为TIMI II演出。 放射性核素（铊）核心实验室， 已经作为TIMI II的核心实验室，将确保 临床单位的应激铊研究质量， 利用其开发的专业分析方法， 对铊缺陷进行定量。 其成本的很大一部分 将由工业提供。 因此，这五个核心实验室将提供专业的 评估这些患者治疗结果所需的分析 急性病患者。 该应用程序的一个特殊优势是 每个实验室先前的任务经验， 将在TIMI III中演出。