Women's Ischemia Syndrome Evaluation

该重新申请建议将女性缺血综合征评估（WISE）患者的随访时间延长至少5年，并与“肾素血管紧张素系统改变作为女性冠状动脉微血管功能障碍的机制”（C. Pepine PI）和“女性冠状动脉疾病的免疫学基础”（S.Reis PI）申请一起提交。WISE合同始于1996年9月，作为一项4个中心的研究，旨在1)优化女性缺血性心脏病的症状评估和诊断测试；2)探讨无心外膜冠状动脉狭窄时的症状和心肌缺血机制；3)评价生殖激素对症状和诊断试验反应的影响。一个广泛的当代数据库已经收集了936名妇女因怀疑缺血而进行冠状动脉造影。数据包括人口统计学、临床、症状、功能和社会心理变量。冠状动脉造影和脑室造影数据、肱动脉反应性测试、心电图监测和血液测定均由核心实验室评估。部位特异性创新技术已被用于开发潜在的心肌缺血标志物。我们寻求1)确定WISE开发的新测试的增量长期预后价值；2)建立性别特异性的增量结局模型，评估女性生殖变量的预后价值；3)与传统测试相比，评估WISE创新测试技术的增量成本效益和资源效率；4)继续进行正在进行的分析和辅助项目，与本集群中提交的其他WISE研究者Ro1合作，维护WISE数据库和基础设施，以促进对女性缺血综合征机制的进一步研究。为了实现这些目标，需要更长的后续行动。后续行动将包括由经验丰富的现场协调员每年进行电话联络。WISE将继续使用完善的方法来实施研究协调、数据管理、质量控制、统计分析和稿件准备。Cox回归模型将被用作解释变量。将使用混合决策模型来比较资源使用模式和估算成本。这些研究的结果将增强我们对女性缺血性心脏病的意义和病理生理学的理解，并为旨在降低疾病相关发病率和死亡率的诊断和治疗临床试验奠定基础。

This reapplication proposes to extend the follow-up of the Women's Ischemia Syndrome Evaluation (WISE) patients for a minimum of 5 years and is being submitted jointly with the applications "Altered Renin Angiotensin System as a Mechanism for Coronary Microvascular Dysfunction in Women" (C. Pepine PI) and "Immunologic Basis For Coronary Disease in Women" (S.Reis PI). The WISE contract began in September 1996 as a 4-center study to 1) optimize symptom evaluation and diagnostic testing for ischemic heart disease in women; 2) explore mechanisms for symptoms and myocardial ischemia in the absence of epicardial coronary artery stenoses; and 3) evaluate the influence of reproductive hormones on symptoms and diagnostic test response. An extensive contemporary database has been assembled on 936 women referred for coronary angiography because of suspected ischemia. Data include demographic, clinical, sympotmatic, functional, and psychosocial variables. Coronary angiography and ventriculography data, brachial artery reactivity testing, ECG monitoring, and blood determinations are all assessed by core laboratories. Site-specific innovative technologies have been used to develop potential markers of myocardial ischemia. We seek to 1) Determine the incremental long-term prognostic value of novel testing developed in WISE; 2) Develop sex-specific incremental outcome models to evaluate the prognostic value of female reproductive variables; 3) Assess the incremental cost effectiveness and resources efficiency of the WISE innovative testing techniques as compared with traditional tests; 4) Continue ongoing analyses and ancillary projects, collaborate with other WISE investigators Ro1's submitted in this cluster, and maintain a WISE database and infrastructure to facilitate further investigations into the mechanisms underlying ischemia syndromes in women. To address these aims, a longer follow-up is necessary. Follow-up will consist of annual telephone contacts by experienced site coordinators. WISE will continue to use the well-established methods to implement study coordination, data management, quality control, statistical analyses, and manuscript preparation. Cox regression models will be used as explanatory variables. A hybrid decision model will be used that compares resource use patterns and sums cost estimates. The results of these studies will enhance our understanding of both the significance and pathophysiology of ischemic heart disease in women and serve as a foundation for diagnostic and therapeutic clinical trials aimed at reducing disease-related morbidity and mortality.