Abstract 78: Pre-hospital Rapid Neurological Improvement in Acute Stroke Syndromes: Frequency and Clinical Outcomes

Stroke ◽  
2016 ◽  
Vol 47 (suppl_1) ◽  
Author(s):  
Clotilde Balucani ◽  
Steven R Levine ◽  
Nerses Sanossian ◽  
Sidney Starkman ◽  
David S Liebeskind ◽  
...  

Introduction: There are no systematic data evaluating frequency and clinical outcome of patients with acute stroke syndromes presenting with rapid neurological improvement (RNI) in the pre-hospital setting. Our objectives were to determine frequency, magnitude, and clinical outcomes of RNI vs no-RNI. Hypothesis: Pre-hospital RNI predicts favorable clinical outcome as compared to no-RNI in acute stroke syndromes. Methods: Post-hoc analysis of The Field Administration of Stroke Therapy-Magnesium (FAST-MAG), a phase 3, randomized, double-blind, placebo-controlled clinical trial. Any-RNI was defined as a decrease of 2 or more points from the pre-hospital Los Angeles Motor Scale (PH-LAMS) to the hospital LAMS (H-LAMS), while dramatic-RNI was defined as a decrease of at least 4 points. Outcomes were: excellent recovery at 90 days (0-1 mRS), discharge disposition (home vs. not home), and death. Results: In the overall cohort of 1,700 subjects in FAST-MAG, frequency of any-RNI was 326 (19%), dramatic-RNI 98 (6%) and no-RNI 1,276 (75%). Mean age 71.4 (+/-13.2 SD), 67.1 (+/-13.3) and 69.1 (+/-13.6) for any-RNI, dramatic-RNI and no-RNI, respectively (p= 0.004). There was no gender difference across the 3 groups (p= 0.204). Hypertension (p=0.008) and diabetes (p= 0.014) were significantly less frequent among any-RNI and dramatic-RNI vs no-RNI. PH-LAMS medians: any-RNI: 3 (IQR 3-5), dramatic-RNI: 5 (4-5) and no-RNI: 4 (3-5), (p<.0001). Median hospital NIHSS was: any-RNI 3 (1-6), dramatic-RNI 0 (0-2) vs no-RNI 12 (6-20) (p<.0001). Any-RNI and dramatic-RNI were more likely to be discharged home (53% and 64%, respectively) vs no-RNI (25%) (p<.0001). Any-RNI (61%) was more likely to have excellent outcome vs no-RNI (28%) (p<0.0001) and after adjusting for covariates, the OR was 1.33 (95%CI 1.00-1.76, p=0.046). Conclusions: Frequency of pre-hospital any-RNI in the FAST-MAG cohort was almost 1 in 5 subjects, with 6% having dramatic recovery. While clinical outcomes were overall more favorable for acute stroke syndromes presenting with RNI, 47% (any-RNI) and 36% (dramatic-RNI) were not discharged home. Our data suggest that RNI in the pre-hospital setting does not always translate to favorable outcome. Factors affecting outcome in RNI need to be further explored.

Stroke ◽  
2015 ◽  
Vol 46 (suppl_1) ◽  
Author(s):  
Manabu Inoue ◽  
Michael Mlynash ◽  
Carlo W Cerada ◽  
Nishant K Mishra ◽  
Soren Christensen ◽  
...  

Background and purpose: Fluid-attenuated inversion recovery (FLAIR) vessel hyper-intensities (FVH) have been hypothesized to have a positive correlation with good collaterals and more favorable clinical outcomes in acute stroke patients. We assessed if FVH predict the Target mismatch profile (TMM) and clinical outcomes in the DEFUSE studies. Methods: Patients with technically adequate baseline diffusion weighted images (DWI), perfusion images (PWI), and FLAIR images were included in this pooled analysis of the DEFUSE 1 and 2 studies. The FVH sign was defined as visible hyper-intense vessels on FLAIR images and assessed at basal ganglia levels by two independent raters. Clinical outcomes were assessed using modified Rankin Scale (mRS) at 90 days. The Target mismatch profile was based on baseline DWI and PWI volumes using automated software (RAPID). Results: Seventy seven patients met the inclusion criteria. Median time (IQR) from symptom onset to baseline MRI was 4.6 hours (3.9 - 5.4) and median (IQR) DWI lesion was 13.1 (5.0 - 32.0) ml. Of these, 66 patients (86%) had the FVH sign. Kappa score for inter-rater agreement was 0.621 (95CI: 0.33 - 0.91). Seventy (74%) cases with FVH had TMM profile vs. 33% of No FVH patients (p=0.023). Good clinical outcome (mRS 0-2) did not differ (50% with FVH vs. 73% without FVH, p=0.203). Only 38% of the patients with FVH had good angiographic collaterals and the rate of early reperfusion did not differ (45% with FVH vs. 25% without FVH, p=0.45). Conclusions: FVH is common in acute stroke patients (86%) and is associated with the Target Mismatch profile. However, FVH was not associated with favorable angiographic collaterals, good clinical outcome or early reperfusion in the DEFUSE 1 and 2 cohorts.


Stroke ◽  
2012 ◽  
Vol 43 (suppl_1) ◽  
Author(s):  
Alejandro Magadan ◽  
Marie Luby ◽  
Steven Warach

Introduction: Because IV tPA treatment initiated within 4.5 hours is the only acute stroke therapy of proven clinical efficacy, this population offers the greatest validity for determining imaging markers that optimally would differentiate clinical outcomes in treated vs. placebo patients in later time-window clinical trials. The Perfusion Diffusion Mismatch (PDM) approximates the ischemic penumbra, but there is no consensus on the optimal definition or threshold to be used in trials. We assessed the relationship of mismatch size to clinical outcome of an IV tPA treated sample compared with an untreated cohort. Methods: We selected patients from the NINDS Lesion Evolution of Stroke and Ischemia On Neuroimaging (LESION) database who met the following criteria: 1) treated with standard IV tPA 2) received multimodal MRI pre-treatment including diffusion (DWI) and perfusion imaging (PWI), 3) had interpretable MRI imaging showing 4) non-lacunar infarcts or lesions less than 100 ml volumes on DWI and 5) follow-up modified Rankin Score (mRS). We also selected 23 acute stroke patients who did not receive treatment but otherwise met the same criteria. Volumes were measured from the DWI and Mean Transit Time (MTT) images. PDM was defined as either a volume (MTT-DWI) or a percentage (MTT-DWI/MTT). Good outcome was defined as mRS of 0-1. Logistic regression was performed to predict good outcome with covariates of age, initial NIHSS, PDM size, tPA treatment, and tPA treatment by PDM size interaction. Result: Ninety-six patients were treated with IV tPA, 23 patients had no treatment. The figures , showing the unadjusted proportions of patients achieving good outcome as a function of minimum PDM size, suggest greater separation of treated and untreated patients at larger PDM sizes. For percentage PDM a significant interaction of tPA treatment by PDM size was observed at ≥ 80% (p=0.029), indicating that the benefit of tPA treatment is greater for PDM ≥ 80%. For volume PDM, the interaction of tPA treatment by PDM size trended positive at ≥ 50 ml (p=0.058). Conclusion: Greater differences in clinical outcomes with IV tPA versus untreated patients were evident with PDM ≥ 80% or ≥ 50 ml. These minimums of PDM size suggest an optimal target for thrombolytic trials.


2016 ◽  
Vol 21 (03) ◽  
pp. 339-344 ◽  
Author(s):  
Chul-Hyun Cho ◽  
Geon-Myeong Oh

Background: The objective of this study was to determine prognostic factors affecting the clinical outcome of septic arthritis of the shoulder. Methods: We retrospectively reviewed 34 shoulders from 32 patients, two of which had bilateral involvement. Arthroscopic (22 shoulders) or open surgery (12 shoulders) was performed by a single surgeon. The mean follow-up period was 32.4 ± 17.0 months. Clinical outcomes according to the University of California at Los Angeles (UCLA) score, American Shoulder and Elbow Surgeons (ASES) score, and Subjective Shoulder Value (SSV) were assessed at the final follow-up period. Various factors were included for statistical analysis. Results: The mean UCLA, ASES scores, and SSV were 28.9 ± 7.2, 81.3 ± 21.0, 79.7 ± 2.5%, respectively. Positive culture was observed in only 13 shoulders (38.2%) and the most common organism was Staphylococcus aureus (seven shoulders). Five shoulders (14.7%) required two or three operations. Age and comorbidity were negatively correlated with the UCLA, ASES score, and/or SSV (p < 0.05). There was no correlation between clinical outcome and various parameters, including gender, location of lesion, history of previous steroid injection, interval between onset of symptoms and surgical intervention, bacterial organisms, operative method, and presence of rotator cuff tear and reoperation (p > 0.05). Conclusions: Both arthroscopic and open surgery for septic shoulders showed satisfactory clinical outcomes. Old age and comorbidity were poor prognostic factors of clinical outcomes after treatment.


2021 ◽  
Vol 14 ◽  
pp. 175628642110458
Author(s):  
Lina Palaiodimou ◽  
Vasileios-Arsenios Lioutas ◽  
Vaia Lambadiari ◽  
Aikaterini Theodorou ◽  
Marios Themistocleous ◽  
...  

Introduction: Glycemic variability (GV) has been associated with worse prognosis in critically ill patients. We sought to evaluate the potential association between GV indices and clinical outcomes in acute stroke patients. Methods: Consecutive diabetic and nondiabetic, acute ischemic or hemorrhagic stroke patients underwent regular, standard-of-care finger-prick measurements and continuous glucose monitoring (CGM) for up to 96 h. Thirteen GV indices were obtained from CGM data. Clinical outcomes during hospitalization and follow-up period (90 days) were recorded. Hypoglycemic episodes disclosed by CGM but missed by finger-prick measurements were also documented. Results: A total of 62 acute stroke patients [48 ischemic and 14 hemorrhagic, median NIHSS score: 9 (IQR: 3–16) points, mean age: 65 ± 10 years, women: 47%, nondiabetic: 79%] were enrolled. GV expressed by higher mean absolute glucose (MAG) values was associated with a lower likelihood of neurological improvement during hospitalization before and after adjusting for potential confounders (OR: 0.135, 95% CI: 0.024–0.751, p = 0.022). There was no association of GV indices with 3-month clinical outcomes. During CGM recording, 32 hypoglycemic episodes were detected in 17 nondiabetic patients. None of these episodes were identified by the periodic blood glucose measurements and therefore they were not treated. Conclusions: Greater GV of acute stroke patients may be related to lower odds of neurological improvement during hospitalization. No association was disclosed between GV indices and 3-month clinical outcomes.


Neurology ◽  
2019 ◽  
Vol 93 (3) ◽  
pp. e283-e292 ◽  
Author(s):  
Chushuang Chen ◽  
Mark W. Parsons ◽  
Christopher R. Levi ◽  
Neil J. Spratt ◽  
Ferdinand Miteff ◽  
...  

ObjectiveTo assess whether complete reperfusion after IV thrombolysis (IVT-R) would result in similar clinical outcomes compared to complete reperfusion after endovascular thrombectomy (EVT-R) in patients with a large vessel occlusion (LVO).MethodsEVT-R patients were matched by age, clinical severity, occlusion location, and baseline perfusion lesion volume to IVT-R patients from the International Stroke Perfusion Imaging Registry (INSPIRE). Only patients with complete reperfusion on follow-up imaging were included. The excellent clinical outcome rates at day 90 on the modified Rankin Scale (mRS) were compared between EVT-R vs IVT-R patients within quintiles of increasing baseline ischemic core and penumbral volumes.ResultsFrom INSPIRE, there were 141 EVT-R patients and 141 matched controls (IVT-R) who met the eligibility criteria. In patients with a baseline core <30 mL, EVT-R resulted in a lower odds of achieving an excellent outcome at day 90 compared to IVT-R (day 90 mRS 0–1 odds ratio 0.01, p < 0.001). The group with a baseline core <30 mL contained mostly patients with distal M1 or M2 occlusions, and good collaterals (p = 0.01). In patients with a baseline ischemic core volume >30 mL (internal carotid artery and mostly proximal M1 occlusions), EVT-R increased the odds of patients achieving an excellent clinical outcome (day 90 mRS 0–1 odds ratio 1.61, p < 0.001) and there was increased symptomatic intracranial hemorrhage in the IVT-R group with core >30 mL (20% vs 3% in EVT-R, p = 0.008).ConclusionFrom this observational cohort, LVO patients with larger baseline ischemic cores and proximal LVO, with poorer collaterals, clearly benefited from EVT-R compared to IVT-R alone. However, for distal LVO patients, with smaller ischemic cores and better collaterals, EVT-R was associated with a lower odds of favorable outcome compared to IVT-R alone.


2021 ◽  
Vol 8 ◽  
pp. 204993612110582
Author(s):  
Simon Portsmouth ◽  
Roger Echols ◽  
Kiichiro Toyoizumi ◽  
Glenn Tillotson ◽  
Tsutae Den Nagata

Background: The APEKS-cUTI study demonstrated the non-inferiority of cefiderocol to imipenem−cilastatin in the primary endpoint of the composite of clinical and microbiological outcome in patients with complicated urinary tract infections (cUTIs). We piloted a structured patient interview (SPI) to evaluate clinical outcomes based on patient-reported symptoms while conducting this pivotal randomized, double-blind, phase-2 study. The objectives were to assess the value of the SPI, using its performance relative to physician assessment, and also to strengthen the value of patient-reported measures in conducting clinical trials for cUTI treatment. Methods: In addition to the protocol-defined clinical and microbiological outcomes, patients randomized in the APEKS-cUTI study were interviewed by the investigator or qualified study personnel at screening/baseline, early assessment (EA), end of treatment (EOT), test of cure (TOC), and follow-up (FUP). The 14-element questionnaire graded cUTI symptoms as absent or present, and if present, as mild, moderate, or severe. Changes in post-baseline symptoms based on patients’ responses were rated by the interviewer. The overall clinical outcome was evaluated based on the responses provided by patients at each time point. Results: Among the 371 patients in the modified intention-to-treat population, the rate of SPI completion in each treatment arm exceeded 90% at each time point. SPI-assessed clinical cure rates were 89.7% in the cefiderocol arm and 84.9% in the imipenem–cilastatin arm. There was substantial agreement between SPI evaluation and investigator global assessment of clinical outcome at TOC and FUP, with lower agreement at EA and EOT. Conclusion: This analysis suggests that patient-reported symptoms can be effectively captured in hospitalized patients with cUTI in a clinical trial setting. Development of a validated patient-reported outcome for use in such a setting is warranted. Registration: NCT02321800 (registered on 22 December 2014).


2018 ◽  
Author(s):  
Mariam Al-Laith ◽  
Marianna Jasenecova ◽  
Sonya Abraham ◽  
Aisla Bosworth ◽  
Ian N. Bruce ◽  
...  

Abstract Background: Individuals with joint pain and carrying serum autoantibodies associated with rheumatoid arthritis (RA) are at high risk of developing RA. While there are currently no evidence-based guidelines to inform therapy decisions for such subjects, there are therapies licensed for the treatment of established RA that target pathways implicated in the earliest phase of the disease. Accordingly, we set out to test the feasibility, acceptability and effectiveness of a 52-week period of treatment with the first in class costimulatory blocker abatacept for preventing or delaying the onset of inflammatory arthritis. Methods and Design The APIPPRA study was designed as a randomised, double blind, parallel group placebo-controlled clinical trial, aiming to recruit 206 male or female subjects from the secondary care hospital setting across the UK and the Netherlands. Participants aged 18 or over who report inflammatory sounding joint pain (clinically suspicious arthralgia) and who are found to be positive for serum autoantibodies associated with RA, will be randomised to receive weekly injections of investigational medicinal product (IMP), either abatacept or placebo treatment over a 52-week period. All study subjects consent to a further 52 weeks of follow up to monitor for the primary endpoint, the time to development of ≥ 3 swollen joints, or to the fulfillment of the 2010 ACR/EULAR classification criteria for RA using swollen but not tender joints, whichever endpoint is met first. In either case, swollen joints are confirmed by ultrasonography. Discussion There is limited experience of the design and implementation of trials for the prevention of inflammatory joint diseases. Here, we propose to explore the effects of immunomodulatory therapy at the very earliest detectable phase of disease using an intervention that is already licensed for use in established RA. We discuss the rationale behind choice and duration of treatment, the challenges associated with defining the “at risk” state, and offer pragmatic solutions in the protocol to enrolling subjects at risk of RA. Trial registration Current Controlled Trials, ID: ISRCTN46017566. Registered on 04 July 2014


Stroke ◽  
2021 ◽  
Vol 52 (Suppl_1) ◽  
Author(s):  
James C Grotta ◽  
Stephanie Parker ◽  
Asha Jacob ◽  
ritvij bowry ◽  
Patti Bratina ◽  
...  

Introduction: Most clinical research stopped during COVID due to possible impact on data quality and personnel safety. We aimed to assess the impact of COVID on study conduct at sites that continued to enroll patients during the pandemic. Methods: BEST-MSU is an ongoing study of Mobile Stroke Units (MSU) vs standard management of tPA eligible acute stroke patients in the pre-hospital setting. MSU personnel include a vascular neurologist via telemedicine, and a nurse, CT tech, and medics on board using appropriate PPE. During COVID, consent, 90 d mRS and EQ5D could be obtained by phone instead of in person, otherwise management was the same. We compared patient demographics, study metrics, and infection of study personnel during intra- vs pre-COVID eras. Results: Four of 6 BEST-MSU sites continued to enroll during COVID. There was no difference in intra- (n= 41) vs pre- (n= 763) COVID enrolled tPA eligible patients’ age, sex, race (45% vs 41% Black), ethnicity (23% vs 19% Hispanic), or NIHSS (12 vs 12). MSU alert frequency did not change, but percent of screened patients enrolled and treated with tPA declined to 12% from 23% (p<.001); enrollment correlated with local stay at home and reopening (fig). There was no difference in alert to MSU arrival or arrival to tPA times, but on-scene time was 2 min longer (p=.04). There was no difference in ED door to CT, tPA, or EVT times, hospital LOS, discharge disposition, or 90d mRS or EQ5D accuracy. One MSU nurse tested positive but did not require medical care. Conclusion: Clinical research in the pre-hospital setting can be carried out accurately and safely during a pandemic. Study enrollment and tPA treatment rates declined, but otherwise there was no difference in patient demographics, deterioration of study processes, or serious infection of study staff.


Stroke ◽  
2013 ◽  
Vol 44 (suppl_1) ◽  
Author(s):  
Samir R Belagaje ◽  
Vishal Patel ◽  
Chung-Huan Sun ◽  
Cedric Pimentel ◽  
Brenda Glenn ◽  
...  

INTRO: A person with stroke has improved outcomes with post-acute care in an inpatient rehabilitation facility (IRF) compared to those who are discharged to a skilled nursing facility (SNF). However, this research was conducted in an era before acute stroke treatment was widely implemented. Endovascular reperfusion reduces ischemic stroke volume; however treatment effect may be diluted by discharge disposition. In this analysis, we hypothesize that patients will have better 90 day outcomes if they are discharged to a IRF or home compared to a SNF. METHODS: Subjects were identified from a prospective database tracking clinical outcomes of patients treated with endovascular reperfusion from a single primary care stroke center. Data included discharge disposition, NIHSS, THRIVE, HIAT-2, & APACHE II scores, and successful reperfusion. Univariate analysis was performed to assess predictors of good clinical outcome as defined by 90 day modified Rankin scores (mRS) ≤ 2. A binary logistic regression model was used to determine the impact placement to IRF versus a SNF on clinical outcomes. RESULTS: 177 subjects were included in the analyis; mean age was 66±14 and median NIHSS was 20. Modified APACHE II, NIHSS, THRIVE, & HIAT-2 scores were not different between the two groups Discharge dispositions included: 35(19.8%)home, 38(21.5%) IRF, 47(26.6%)SNF and 57(32.3%) died/went to hospice. Of the 85 patients discharged to SNF or IRF, only 26% of patients discharged to SNF compared to 50% to IRF achieved a good clinical outcome (p-value <0.03). In binary logistic regression modeling, after adjusting for age, infarct volume, pre-treatment ASPECT & NIHSS scores, and modified APACHE II score, disposition to SNF was significantly associated with a lower probability of achieving a mRS of 0-2 at 90 days, OR 3.31(95%CI 1.06-9.62, p<0.04). CONCLUSIONS: In our study, subjects discharged to SNF and IRF after thrombectomy have similar medical and neurological severity at admission and similar final infarct volumes at discharge. Despite these similarities, patients discharged to SNF had a significantly lower probability of achieving a good neurological outcome. Further study is required to determine if IRF could be considered in more patients to improve clinical outcomes.


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