An Observational Study of Cardiac Critical Care Management in Multidisciplinary and Cardiac Intensive Care Units

在过去的半个世纪中，冠心病监护病房已经从心肌梗死后的监护和心律失常的主要检测和治疗场所发展到其目前的心脏重症监护病房（CICU）形式。当代CICU为日益老龄化和复杂的患者群体提供护理。现代CICU的临床环境包括与晚期心脏病相关的严重共病和多系统器官功能障碍，包括难治性心力衰竭、缺血和心律失常，以及免疫抑制心脏移植患者的心源性休克甚至感染性休克。 与本项目相关的方案是一项多中心研究，于2018年5月获得国家心肺血液机构审查委员会的批准。该研究由重症监护心脏病学试验网络（CCCTN）的学术执行和指导委员会赞助，并由位于马萨诸塞州波士顿哈佛医学院布里格姆妇女医院的TIMI研究组协调。 在NIH临床中心（CC），数据收集将在2个月的“快照”期间从入住多学科ICU的心脏病成人患者的记录中获取信息。本研究仅涉及患者记录审查，不使用样本或涉及参与者接触。将审查入组NIH方案的受试者与其基础疾病相关的病历。 本研究不涉及对患者护理的任何干预或变更。本研究涉及收集和分析作为常规临床护理的一部分获得的信息，如病历中所记录。将收集在方案批准日期后入住临床中心的合格受试者的数据。只有去识别的数据才会提交给数据协调中心。入选本研究所产生的信息不会对受试者产生任何健康或医学影响，并且将严格遵守隐私标准。 在本报告期间，将NIH CC ICU的19例患者记录输入CCCTN登记研究。在该方案的有效期内（截至2020年8月），共有39份NIH CC ICU患者记录被输入CCCTN登记研究，其中包含超过12，500例患者的信息，其中约4，500例是在2019- 2020报告期内获得的。

During the past half century, the coronary care unit has evolved from a site for post myocardial infarction care and primary detection and treatment of arrhythmias to its current form as a cardiac intensive care unit (CICU). The contemporary CICU provides care for an increasingly aging and complex patient population. The clinical environment of the modern CICU encompasses critical co-morbid conditions and multi system organ dysfunction associated with advanced cardiac conditions ranging from refractory heart failure, ischemia, and dysrhythmias through cardiogenic shock and even septic shock in immunosuppressed heart transplant patients. The protocol related to this project is a multicenter study that was approved by the National Heart Lung and Blood Institutional Review Board in May 2018. The study is sponsored by the Academic Executive and Steering Committees of the Critical Care Cardiology Trials Network (CCCTN) and coordinated by The TIMI Study Group at Brigham and Women's Hospital, Harvard Medical School, Boston, MA. At the NIH Clinical Center (CC), data collection will capture information from records of adult patients with cardiac conditions admitted to the multidisciplinary ICU during a 2 month "snap-shot" period. The study will involve only a review of patient records and will not use specimens or involve participant contact. Medical records will be reviewed from participants enrolled in NIH protocols related to their underlying disease(s). This study will not involve any interventions or changes to the patients care. The study involves collection and analysis of information obtained as part of routine clinical care as documented in the medical record. Data will be collected for eligible subjects admitted to the Clinical Center after the protocol approval date. Only de-identified data will be submitted to the Data Coordinating Center. The information resulting from inclusion in this study will not have any health or medical implications for subjects and privacy standards will be observed rigorously. During the current reporting period 19 patient records from the NIH CC ICU were entered into CCCTN registry. Over the life of the protocol (as of August 2020) a total of 39 NIH CC ICU patient records have been entered into the CCCTN registry which contains information on over 12,500 patients of which about 4,500 were obtained during the 2019-20 reporting period.