Exercise and Pharmacotherapy for Anxiety in Cardiac Patients

 描述(申请人提供)：冠心病(CHD)是美国主要的死亡原因，每年影响60万美国人。术语“心血管脆弱患者”被用来描述基于斑块、血液或心肌特征而易患急性冠状动脉事件的患者。最近的证据表明，在冠心病患者中常见的焦虑可能是一个重要的独立预后因素，也增加了心血管易感性。这一证据为 减少心脏病患者的焦虑。抗焦虑药物，特别是选择性5-羟色胺再摄取抑制剂(SSRIs)，在这方面可能是有效的，尽管这些药物在降低心脏病患者焦虑方面的价值尚未被广泛研究，它们在改善临床结果方面的价值尚不清楚。运动也可能有效地减少焦虑，尽管由于缺乏精心设计的临床研究的数据，运动的治疗潜力仍然没有得到充分发挥。在本申请中提出的研究将：(A)评估运动训练和抗焦虑药物在降低脆弱心脏病患者焦虑方面的有效性；(B)检查中间终点的变化，包括自主神经系统失调、血管内皮功能障碍和慢性炎症的测量，这些指标也是易受不良心脏事件影响的生理标志；(C)对参与者进行长达4年的跟踪调查，以评估包括死亡和非死亡在内的临床事件。 (D)探讨干预措施改善预后的可能机制。150名患有冠心病和焦虑症或焦虑症状升高的男性和女性将被随机分配到运动组、药物组(艾司匹兰)或安慰剂组。在治疗前和治疗3个月后，患者将接受焦虑的临床评估以及自主神经系统调节、血管内皮功能和炎症的测量。6个月的随访将评估心理益处的维持情况，临床结果将被监测长达4年。这项研究产生的数据将具有重要的临床意义，它将确定运动和药物可以在多大程度上降低焦虑，改善冠心病风险的中间标志，并改善包括临床事件和与冠心病相关的住院在内的医疗结果。

 DESCRIPTION (provided by applicant): Coronary heart disease (CHD) is the leading cause of death in the United States, affecting 600,000 Americans each year. The term "cardiovascular vulnerable patient" has been used to describe patients susceptible to acute coronary events based upon plaque, blood, or myocardial characteristics. Recent evidence has suggested that anxiety, which is common in CHD patients, may be a significant and independent prognostic factor that also increases cardiovascular vulnerability. This evidence has provided a rationale for reducing anxiety in cardiac patients. Anxiolytic medications, especially selective serotonin reuptake inhibitors (SSRIs), may be effective in this regard, although the value of these medications in reducing anxiety has not been widely studied in cardiac patients and their value in improving clinical outcomes is not known. Exercise also may be effective in reducing anxiety, although the therapeutic potential of exercise has remained unfulfilled due to a paucity of data from well-designed clinical studies. The study proposed in this application will (a) evaluate the effectiveness of exercise training and anxiolytic medication in reducing anxiety in vulnerable cardiac patients; (b) examine changes in intermediate endpoints, including measures of autonomic nervous system dysregulation, vascular endothelial dysfunction, and chronic inflammation, which also serve as physiologic markers of vulnerability to adverse cardiac events; (c) follow participants for up to 4 years to assess clinical events including fatal and non fatal cardiac events, hospitalizations, and medical costs; and (d) explore possible mechanisms by which the interventions improve outcomes. One hundred fifty men and women with CHD and an anxiety disorder or elevated symptoms of anxiety will be randomly assigned to Exercise, Medication (escitalopram), or Placebo. Before and after 3 months of treatment, patients will undergo clinical assessments of anxiety and measures of autonomic nervous system regulation, vascular endothelial function, and inflammation. A six month follow-up will assess maintenance of psychological benefit and clinical outcomes will be monitored for up to 4 years. The data generated from this study will have important clinical significance by determining the extent to which exercise and medication may reduce anxiety, improve intermediate markers of CHD risk, and improve medical outcomes including clinical events and CHD-related hospitalizations.