ABSTRACT
BACKGROUND AND PURPOSE: Increased blood pressure (BP) variability, in addition to high BP, may contribute to adverse outcome in intracerebral hemorrhage. However, degree and association with outcome of BP variability (BPV) in the hyperacute period, 15 minutes to 5 hours after onset, have not been delineated. METHODS: Among consecutive patients with intracerebral hemorrhage enrolled in the FAST-MAG trial (Field Administration of Stroke Therapy-Magnesium), BPs were recorded by paramedics in the field and during the first 24 hours of hospital course. BP was analyzed in the hyperacute period, from 0 to 4-6 hours, and in the acute period, from 0 to 24-26 hours after onset. BPV was analyzed by SD, coefficient of variation, and successive variation. RESULTS: Among 386 patients with intracerebral hemorrhage, first systolic BP at median 23 minutes (interquartile range, 14-38.5) after onset was median 176 mm Hg, second systolic BP on emergency department arrival at 57 minutes (interquartile range, 45-75) after onset was 178 mm Hg, and systolic BP 24 hours after arrival was 138 mm Hg. Unfavorable outcome at 3 months (modified Rankin Scale, 3-6) occurred in 270 (69.9%). Neither mean nor maximum systolic BP was associated with outcome in multivariable analysis. However, all 3 parameters of BPV, in both the hyperacute and the acute stages, were associated with poor outcome. In the hyperacute phase, BPV was associated with poor outcome with adjusted odds ratios of 3.73 for the highest quintile of SD, 4.78 for the highest quintile of coefficient of variation, and 3.39 for the highest quintile of successive variation. CONCLUSIONS: BPV during the hyperacute first minutes and hours after onset in patients with intracerebral hemorrhage was independently associated with poor functional outcome. Stabilization of BPV during this vulnerable period, in the pre-hospital and early emergency department course, is a potential therapeutic target for future clinical trials. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00059332.
Subject(s)
Blood Pressure/physiology , Cerebral Hemorrhage/physiopathology , Aged , Antihypertensive Agents/therapeutic use , Blood Pressure Determination/methods , Cerebral Hemorrhage/drug therapy , Cerebral Hemorrhage/etiology , Female , Humans , Hypertension/complications , Male , Middle Aged , Risk Factors , Stroke/drug therapyABSTRACT
BACKGROUND AND PURPOSE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00059332.
