Sanossian Nerses, Apibunyopas Kathleen C, Liebeskind David S, Starkman Sidney, Burgos Adrian M, Conwit Robin, Eckstein Marc, Pratt Frank, Stratton Sam, Hamilton Scott, Saver Jeffrey L
From the Department of Neurology, Roxanna Todd Hodges Comprehensive Stroke Clinic (N.S., K.C.A., A.M.B.), and Department of Emergency Medicine (M.E.), University of Southern California, Los Angeles; Department of Neurology, Stroke Center (D.S.L., S. Starkman, J.L.S.) and Neurovascular Imaging Core Laboratory (D.S.L.) and School of Public Health (S. Stratton), University of California, Los Angeles; National Institutes of Neurological Disorders and Stroke, Bethesda, MD (R.C.); Department of Emergency Medicine, Torrance Memorial Medical Center, Torrance, CA (F.P.); Department of Neurology, Stanford University, CA (S.H.).
Stroke. 2016 Nov;47(11):2737-2741. doi: 10.1161/STROKEAHA.116.013318. Epub 2016 Sep 27.
Greater numbers of individuals aged ≥80 years enjoy a high quality of life, yet historically stroke trials have excluded this population. We aimed to describe a population of very elderly successfully enrolled into an acute stroke trial and compare their characteristics and outcomes with the younger cohort.
We analyzed consecutive patients enrolled <2 hours of symptom onset in a prehospital stroke treatment trial, the FAST-MAG clinical trial (Field Administration of Stroke Therapy-Magnesium). We gathered demographic, treatment, and outcome data for nonelderly (<80 years old), very elderly (≥80 years old), and extreme elderly (≥90 years old). We describe key differences in the population of elderly and the impact of their inclusion on the clinical trial.
Of 1700 participants in FAST-MAG, there were 1210 nonelderly, 490 very elderly, and 60 extreme elderly subjects. Very elderly stroke patients successfully enrolled in a research study were more likely to be women, white, and have an ischemic mechanism rather than an intracerebral hemorrhage. Although the very elderly had generally poorer outcomes, 4 in 10 were functionally independent at 90 days.
Inclusion of the very elderly population in acute stroke clinical trials would both significantly increase study participation and generalizability of future acute stroke clinical trials.
URL: http://www.clinicaltrials.gov. Unique identifier: NCT00059332.
越来越多的80岁及以上老年人享有高质量生活，但历史上的中风试验一直将该人群排除在外。我们旨在描述成功纳入急性中风试验的高龄人群，并将他们的特征和结局与较年轻队列进行比较。
我们分析了在一项院前中风治疗试验FAST-MAG临床试验（中风治疗镁剂现场应用）中症状发作后2小时内入组的连续患者。我们收集了非高龄（<80岁）、高龄（≥80岁）和极高龄（≥90岁）患者的人口统计学、治疗和结局数据。我们描述了老年人群的关键差异以及他们的纳入对临床试验的影响。
在FAST-MAG的1700名参与者中，有1210名非高龄患者、490名高龄患者和60名极高龄患者。成功纳入研究的高龄中风患者更可能为女性、白人，且发病机制为缺血性而非脑出血。尽管高龄患者的总体结局通常较差，但十分之四的患者在90天时功能独立。
将高龄人群纳入急性中风临床试验将显著增加研究参与度，并提高未来急性中风临床试验的普遍性。
