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

描述（由申请人提供）：nhlbi赞助的女性缺血综合征评估（WISE）记录了具有缺血症状和证据的女性冠状动脉血管功能障碍的高患病率，无阻塞性CAD。这种情况与不良预后和类似于阻塞性CAD的医疗保健费用有关，估计有200万至300万妇女患有这种疾病，预计每年有10万新病例。这使得冠状动脉血管功能障碍的患病率、发病率和费用高于所有女性生殖癌症的总和。为了将我们的发现转化为临床护理，我们需要对一种无创诊断和预后方法进行前瞻性测试。采用前瞻性随访队列设计，我们的目的是研究：1)心脏磁共振成像（CMRI）异常预测冠状动脉反应性测试（CRT）异常；2)随访1年持续心脏磁共振成像（CMRI）异常可预测持续缺血症状；3) CMRI预测不良后果，因此可以作为未来治疗试验的结果。基线研究访问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况。我们将招募375名女性接受冠状动脉造影，怀疑是缺血，没有阻塞性CAD。所有375人将接受基线CMRI成像，200人将接受为期一年的重复随访CMRI。另一组200名无冠状动脉狭窄的女性（约占20%）将接受CRT治疗。每年与妇女联系，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核心实验室和临床站点。有创CRT和无创CMRI成像之间的联系，以及这一措施对症状和不良后果的预后价值的记录，将为临床试验提供一个平台，在适当的研究中测试治疗干预措施。潜在的治疗试验计划包括抗缺血治疗，如雷诺嗪和双嘧达莫，以及新的干预措施，如红细胞生成素和干细胞治疗，针对冠状动脉血管功能。该应用程序的结果将为执业医师提供将这些发现转化为临床护理的能力，以使用无创评估策略改善妇女的IHD结果。公共卫生相关性：登记数据表明，大多数冠状动脉血管功能障碍的妇女仍未接受循证治疗。需要进一步研究无创评估冠状动脉血管功能障碍的方法，以改善妇女的临床护理和降低医疗保健费用。

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.