Exercise and Pharmacotherapy for Anxiety in Cardiac Patients

 描述（由申请人提供）：冠心病（CHD）是美国的主要死因，每年影响60万美国人。术语“心血管脆弱患者”已被用于描述基于斑块、血液或心肌特征易发生急性冠状动脉事件的患者。最近的证据表明，焦虑，这是常见的冠心病患者，可能是一个重要的和独立的预后因素，也增加了心血管脆弱性。这一证据提供了一个理由， 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，尽管这些药物在减少心脏病患者焦虑方面的价值尚未得到广泛研究，其在改善临床结局方面的价值尚不清楚。运动也可以有效地减少焦虑，尽管由于缺乏精心设计的临床研究的数据，运动的治疗潜力仍未实现。本申请中提出的研究将（a）评估运动训练和抗焦虑药物在减少易受伤害的心脏病患者的焦虑中的有效性;（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，其也用作易受不良心脏事件影响的生理标志物;（c）对参与者进行长达4年的随访，以评估临床事件，包括致命性和非致命性事件。 致命心脏事件、住院和医疗费用;以及（d）探索干预措施改善结果的可能机制。将150名患有CHD和焦虑症或焦虑症状升高的男性和女性随机分配至运动、药物（艾司西酞普兰）或安慰剂组。在治疗前和治疗后3个月，患者将接受焦虑的临床评估和自主神经系统调节、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，并将对临床结局进行长达4年的监测。本研究产生的数据将具有重要的临床意义，通过确定运动和药物治疗可以减少焦虑的程度，改善CHD风险的中间标志物，并改善包括临床事件和CHD相关住院在内的医疗结局。

 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.