Women's Ischemia Syndrome Evaluation (WISE) Coronary Vascular Dysfunction

描述（由申请人提供）：NHLBI申办的女性缺血综合征评价（WISE）记录了冠状动脉血管功能障碍在有症状和缺血证据且无阻塞性CAD的女性中的高患病率。这种疾病与不良预后和类似于阻塞性CAD的医疗费用相关，估计有2-3百万女性患有现有疾病，预计每年有100，000例新发病例。这使得冠状动脉血管功能障碍的患病率、发病率和成本高于所有女性生殖系统癌症的总和。我们需要对诊断和预后的非侵入性方法进行前瞻性测试，这是将我们的发现转化为临床护理的关键下一步。我们采用前瞻性队列设计并随访，旨在研究：1）异常心脏磁共振成像（CMRI）可预测冠状动脉反应性试验（CRT）异常; 2）1年随访时持续性心脏磁共振成像（CMRI）异常可预测缺血的持续症状; 3）CMRI可预测不良结局，因此可用作未来治疗试验的结局。基线研究访视将包括体格检查和询问病史、症状、生活方式和功能特征以及心理社会状态。我们将招募375名因疑似缺血而接受冠状动脉造影的女性患者，无阻塞性CAD。所有375名患者将接受基线CMRI成像，200名患者的亚组将接受重复的一年随访CMRI。另外200名心外膜冠状动脉无冠状动脉狭窄>20%的女性将接受CRT。将每年联系女性，以测量症状、冠状动脉事件和相关费用的结果。将使用已建立的WISE核心实验室和临床研究中心。有创CRT和无创CMRI成像之间的联系，以及该措施对症状和不良结局的预后价值，将为临床试验提供一个平台，以在适当的动力研究中测试治疗干预措施。正在计划的潜在治疗试验包括抗缺血疗法，如雷诺嗪和潘生丁，以及新的干预措施，如促红细胞生成素和干细胞疗法，靶向冠状动脉血管功能。该应用程序的结果将提供执业医师的能力，将这些发现转化为临床护理，以改善IHD的结果，在妇女使用无创评估策略。 公共卫生相关性：登记数据表明，大多数女性冠状动脉血管功能障碍仍然未经循证治疗。因此，需要进一步研究无创性评价冠状动脉功能障碍的方法，以提高临床护理水平，降低医疗费用。

DESCRIPTION (provided by applicant): The NHLBI-sponsored Women's Ischemia Syndrome Evaluation (WISE) has documented a high prevalence of coronary vascular dysfunction in women with symptoms and evidence of ischemia with no obstructive CAD. The condition is associated with an adverse prognosis and healthcare costs similar to obstructive CAD, there are an estimated 2-3 million women with existent disease, and a projected 100,000 new cases annually. This places the prevalence, morbidity and costs of coronary vascular dysfunction higher than all female reproductive cancers combined. Prospective testing of a noninvasive approach for diagnosis and prognosis is needed as critical next steps toward translation of our findings into clinical care. Using a prospective cohort design with follow-up, we aim to investigate: 1) Abnormal cardiac magnetic resonance imaging (CMRI) predicts abnormalities in coronary reactivity testing (CRT); 2) Persistent cardiac magnetic resonance imaging (CMRI) abnormalities at 1-year follow-up predict persistent symptoms of ischemia; 3) CMRI predicts adverse outcomes, and thus can be used as an outcome in future therapeutic trials. The baseline study visit will include a physical exam and elicitation of medical history, symptoms, lifestyle and functional characteristics, and psychosocial status. We will recruit 375 women undergoing coronary angiography for suspected ischemia with no obstructive CAD. All 375 will undergo baseline CMRI imaging, and a subgroup of 200 will undergo repeat one-year follow-up CMRI. An additional subgroup of 200 women with no coronary stenosis >20% in any epicardial coronary artery will undergo CRT. Women will be contacted annually to measure outcome of symptoms, coronary events, and associated costs. Established WISE core laboratories and clinical sites will be used. Documentation of the link between invasive CRT and noninvasive CMRI imaging, and the prognostic value of this measure for symptoms and adverse outcomes, will provide a platform for clinical trials to test therapeutic interventions in appropriately powered studies. Potential therapeutic trials being planned include anti-ischemia therapies, such as ranolazine and dipyridamole, as well as novel interventions, such as erythropoietin and stem-cell therapy, targeting coronary vascular function. Results of the application will provide practicing physicians with the ability to translate these findings to clinical care to improve IHD outcomes in women using a noninvasive assessment strategy. PUBLIC HEALTH RELEVANCE: Registry data indicate that most women with coronary vascular dysfunction remain untreated with evidence-based care. Further investigation into approaches to the noninvasive assessment coronary vascular dysfunction is needed to improve clinical care and lower health care cost for women.