THROMBOLYSIS IN MYOCARDIAL ISCHEMIA-CORE APPLICATION

申请者代表五个经验丰富的核心实验室， 计划为以下目标提供集中化的盲目终端分析 TIMI III对不稳定型心绞痛和非Q波心肌梗死患者的研究。 TIMI IIIA和IIIB协议的详细信息包含在 随行临床，应用。 定量血管造影术核心实验室(TIMI IIIA) 已经提供了对1600多个冠状动脉的定量评估 先前研究中的血管造影术，包括TIMI I和II。这 实验室将识别冠状动脉狭窄的变化和 T-PA治疗后的血流量。 心电/ETT核心实验室(TIMI IIIA和IIIB)拥有广泛的 使用明尼苏达州法规的经验本实验室将 确认符合心电输入标准，验证缺血性心电 疼痛发作期间发生的变化，并提供标准化 ETT期间记录的ECG的解释。 动态心电(AEOG)监测核心实验室(TIMI IIIA和 IIIB)，拥有先进的计算机化系统，用于 动态心电监测ST段改变的分析。它 将提供其他未检测到的缺血发作的数据 治疗后--与预后不良相关的变化。 定性血管造影术核心实验室(TIMI IIIB)将 确保血管造影检查和PTCA的质量，并评估 血管造影术对治疗的反应--目前的功能 为TIMI II表演。 放射性核素(铊)核心实验室(TIMI IIISB)，它有 已经成为TIMI II的核心实验室，将确保 临床单位和医院应激铊研究的质量 利用它已经发展到的专门的分析方法 对铊缺陷进行量化。其成本的很大一部分 将由工业界提供。 因此，这五个核心实验室将提供专门的 评估这些患者的治疗结果所需的分析 病情严重的病人。该应用程序的一个特殊优点是 每个实验室完成任务之前的经验 将在TIMI III中表演。

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.