Idriss Salim F, Berger Stuart, Harmon Kimberly G, Kindman Allen, Kleiman Robert, Lopez-Anderson Martha, Molossi Silvana, Saarel Tess Elizabeth, Strnadova Colette, Todaro Thomas, Shinagawa Kaori, Morrow Valarie, Krucoff Mitchell, Vetter Victoria, Wright Theressa J
Division of Cardiology, Department of Pediatrics, Duke University Medical Center Durham, NC.
Division of Pediatric Cardiology, Department of Pediatrics, Ann & Robert H. Lurie Children's Hospital of Chicago, Northwestern University Feinberg School of Medicine, Chicago, IL.
Am Heart J. 2017 Aug;190:123-131. doi: 10.1016/j.ahj.2017.05.003. Epub 2017 May 18.
This White Paper, prepared by members of the Cardiac Safety Research Consortium, discusses important issues regarding sudden cardiac death in the young (SCDY), a problem that does not discriminate by gender, race, ethnicity, education, socioeconomic level, or athletic status. The occurrence of SCDY has devastating impact on families and communities. Sudden cardiac death in the young is a matter of national and international public health, and its prevention has generated deep interest from multiple stakeholders, including families who have lost children, advocacy groups, academicians, regulators, and the medical industry. To promote scientific and clinical discussion of SCDY prevention and to germinate future initiatives to move this field forward, a Cardiac Safety Research Consortium-sponsored Think Tank was held on February 21, 2015 at the US Food and Drug Administration's White Oak facilities, Silver Spring, MD. The ultimate goal of the Think Tank was to spark initiatives that lead to the development of a rational, reliable, and sustainable national health care resource focused on SCDY prevention. This article provides a detailed summary of discussions at the Think Tank and descriptions of related multistakeholder initiatives now underway: it does not represent regulatory guidance.
本白皮书由心脏安全研究联盟成员撰写,讨论了关于青年心脏性猝死(SCDY)的重要问题,这一问题不受性别、种族、民族、教育程度、社会经济水平或运动状态的限制。SCDY的发生对家庭和社区具有毁灭性影响。青年心脏性猝死是一个国内和国际公共卫生问题,其预防引起了包括失去孩子的家庭、倡导团体、学者、监管机构和医疗行业在内的多个利益相关者的浓厚兴趣。为促进关于SCDY预防的科学和临床讨论,并推动该领域未来举措的开展,2015年2月21日在美国食品药品监督管理局位于马里兰州银泉市的白橡树园区举行了一次由心脏安全研究联盟主办的智库会议。该智库会议的最终目标是激发各项举措,以促成开发一个合理、可靠且可持续的专注于SCDY预防的国家医疗保健资源。本文详细总结了智库会议的讨论内容以及目前正在进行的相关多方利益相关者举措:它并不代表监管指导意见。