Women's Ischemia Syndrome Evaluation

女性缺血综合症评估

• 批准号: 6319440
• 负责人: Sheryl F Kelsey
• 金额: $ 85.38万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-05-01 至 2006-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6319440
• 关键词: angiography; cardiovascular disorder diagnosis; cardiovascular disorder epidemiology; cooperative study; cost effectiveness; diagnosis design /evaluation; electrocardiography; gender difference; hormone regulation /control mechanism; human data; human subject; interview; longitudinal human study; myocardial ischemia /hypoxia; outcomes research; pathologic process; patient oriented research; prognosis; women's health

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.

这项重新申请建议将女性缺血综合征评估(WISE)患者的随访延长至少5年，并与申请“改变的肾素血管紧张素系统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)一起提交。WISE合同始于1996年9月，是一项四中心研究，旨在1)优化女性缺血性心脏病的症状评估和诊断测试；2)在没有心外膜冠状动脉狭窄的情况下探索症状和心肌缺血的机制；3)评估生殖激素对症状和诊断测试反应的影响。一个广泛的当代数据库已经收集了936名因疑似缺血而进行冠状动脉造影的女性。数据包括人口统计学、临床、交感、功能和心理社会变量。冠状动脉造影术和心室造影术数据、臂动脉反应性测试、心电监测和血液测定都由核心实验室评估。特定部位的创新技术已被用于开发潜在的心肌缺血标记物。我们寻求1)确定WISE开发的新型测试的增量长期预后价值；2)开发针对性别的增量结果模型以评估女性生殖变量的预后价值；3)评估与传统测试相比，WISE创新测试技术的增量成本效益和资源效率；4)继续进行分析和辅助项目，与其他WISE研究员RO1‘S在本群组中提交的合作，并维护WISE数据库和基础设施，以促进对女性缺血综合征潜在机制的进一步研究。为了实现这些目标，有必要采取更长期的后续行动。后续行动将包括由经验丰富的现场协调员进行年度电话联系。WISE将继续使用成熟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。考克斯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总成本估计。这些研究的结果将加深我们对女性缺血性心脏病的意义和病理生理学的理解，并为旨在减少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。