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Introduction Mild deficit is a relative contraindication to administration of IV rtPA for acute ischemic stroke. However, what constitutes “mild” deficit is vague. Prior studies showed patients with mild strokes have substantial disability rates at hospital discharge and at 90 days. We investigated whether the application of a new definition altered the rates of disability overall, and assessed the effects of thrombolysis. Methods This analysis included all adult acute ischemic stroke patients from a prospective registry of consecutive patients (UCSD SPOTRIAS database, 2003-2014) with 90-day mRS score available who were defined as “mild” using either: NIHSS 0-5 or a TREAT Task Force definition (NIHSS 0-5 and non-disabling based on pre-specified syndromes). Dichotomized 90-day mRS were compared between treated and untreated patients using the two definitions. Results Of 802 ischemic stroke patients with mRS scores available, 184 had baseline mRS(0) and met TREAT criteria; 45(24.5%) were rtPA-treated. Among treated patients, 35.6% had 90-day mRS(2-6), versus 28.8% in the untreated group, a non-significant difference after adjusting for baseline NIHSS (p=0.47). None of the 45 treated patients had symptomatic hemorrhage. Outcomes were similar using the simpler NIHSS 0-5 definition. Conclusions About one-third of mild stroke patients were not functionally independent at 90 days, irrespective of treatment or mild definition applied, calling into question the treatment efficacy of IV rtPA for mild strokes as well as what constitutes an appropriate definition of “mild”. Randomized studies are necessary to determine rtPA treatment efficacy in mild stroke patients.

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Background: Treatment of patients with acute ischemic stroke on mobile stroke units (MSUs) improves outcomes compared with management by standard emergency medical services ambulances and is associated with more patients treated with intravenous tPA (tissue-type plasminogen activator) in the first golden hour after last known normal. We explored the predictors and outcomes of first-hour treatment (FHT) compared with later treatment in an alternating-week cluster-controlled trial of MSUs. Methods: We analyzed all patients treated with intravenous tPA in the BEST-MSU Study (Benefits of Stroke Treatment Delivered by a Mobile Stroke Unit Compared to Standard Management by Emergency Medical Services). After stratifying by treatment timeframe, we identified factors associated with FHT. We performed adjusted analyses of the association between FHT and clinical outcome and modeled the shape of the relationship between last known normal–to–treatment time and excellent outcome. Results: Among 941 tPA-treated patients, 206 (21.8%) had lytic started within 60 minutes. Treatment on the MSU, older age, male sex, alert by 911, faster arrival on-scene and imaging, more severe stroke, atrial fibrillation, and absence of heart failure and pretreatment antihypertensive treatment were associated with FHT. Compared with later treatment, FHT was associated with higher adjusted odds ratio for 90-day modified Rankin Scale score of 0 to 1 (odds ratio, 1.87 [95% CI, 1.25–2.84]; P =0.003). Among FHT patients, 68% achieved a 90-day modified Rankin Scale of 0 or 1 or returned to their baseline status. FHT was not associated with higher risk of hemorrhage and was associated with reduced risk of treating neurovascular mimics. Conclusions: FHT almost doubles the odds of excellent clinical outcome without increased risk compared with later treatment, which supports the use of MSUs.

Background Emergent informed consent for clinical trials in acute myocardial infarction (AMI) and stroke is challenging. The role and value of consent are controversial, and insufficient data exist regarding patients’ and surrogates’ experiences. Methods and Results We conducted structured interviews with patients (or surrogates) enrolled in AMI or acute stroke trials at 6 sites between 2011 and 2016. Primary domains included trial recall, consent experiences, and preferences regarding involvement. Descriptive and test statistics were used to characterize responses and explore relationships between key domains and characteristics. Multivariable logistic regression was used to examine associations between key covariates and consent preferences. There were 176 (84 stroke, 92 AMI) completed interviews. Most stroke respondents (82%) were surrogates; all AMI respondents were patients. Average time from trial enrollment to interview was 1.9 years (stroke) and 2.8 years (AMI); 89% of stroke and 62% of AMI respondents remembered being in the trial, and among these respondents, 80% (stroke) and 44% (AMI) remembered reading some of the consent form. Over 90% reported not feeling pressure to enroll, being treated in a caring way, and being treated with dignity. A minority (16% stroke and 26% AMI) reported they would have preferred not to be asked for consent. Just over half (61% stroke and 53% AMI) recalled a postenrollment conversation about the study. Conclusions Most respondents felt they were treated respectfully and were glad they had been asked for consent. Trial recall was relatively low, and many respondents recalled little postenrollment discussion. Further development of context‐sensitive approaches to consent is important.

Introduction Given the time-sensitivity of thrombolytic therapy, the accurate documentation of last known normal (LKN) time is crucial to ensure optimal management of stroke patients. This study investigates whether a difference exists between preliminary LKN times (first responders and ED practitioners) and revised LKN times (neurology/stroke practitioners), and what potential impact on emergent management of acute stroke this discrepancy may pose. Methods All stroke code patients from UCSD hospitals from 10/2008 to 7/2013 with treatment time data were included and grouped based on the disparity between preliminary LKN time and revised LKN time: preliminary earlier than revised, two times equal, and preliminary later than revised. We compared baseline characteristics, stroke code intervals, rates of rt-PA administration, 90 day mRS score, discharge disposition, and symptomatic intracranial hemorrhage. Results 73.6% of 261 patients had disparity between preliminary and revised times. 57.5% had later preliminary LKN than revised; 16.1% had earlier preliminary LKN than revised. Baseline characteristics, stroke code speed, 90 day mRS score, rates of rt-PA administration, discharge disposition, or rates of sICH were not significantly different between the groups. Among rt-PA treated stroke patients whose preliminary time was earlier than the revised time, had the preliminary LKN been used, 29.4% would have had rt-PA withheld inappropriately. In those stroke patients excluded from rt-PA treatment for being outside the treatment window, whose preliminary time was later than the revised time, had the preliminary time been used, 69.7% would have been inappropriately treated outside the relevant rt-PA window. Conclusions Most patients had disparity between preliminary and revised LKN times. Had the preliminary LKN time been used for acute stroke decision making, 58% of patients would have potentially been treated outside the approved thrombolytic time window, with higher risk of adverse events and 16% may have been inappropriately excluded from thrombolysis. This study highlights the need for training in the determination and refinement of the actual time of stroke onset, especially at hospitals without stroke expertise.

Background/Purpose Intravenous Alteplase (t-PA) improves outcome in patients with acute ischemic stroke. Of those with full recovery, some may not have had ischemia. We analyzed the frequency and post-treatment outcomes of stroke code patients with no imaging evidence of stroke in order to establish the incidence of neuroimaging negative cerebral ischemia (NNCI) and stroke mimics treated with t-PA. In addition, we compared these patients to the group of stroke patients with imaging evidence of acute stroke to determine whether there was a difference in adverse events, and functional outcomes. Methods We included all adult stroke patients treated with IV t-PA within 3 hours of stroke onset from the UCSD SPOTRIAS database through January 2013. The IPS group (Imaging Positive Stroke codes) was comprised of patients with neuroimaging evidence of acute ischemic stroke, while the INS group (Imaging Negative Stroke codes) included those patients without neuroimaging evidence of acute cerebral ischemia. All final diagnoses were reviewed by an adjudicating body. We reviewed medical records and neuroimaging; compared discharge diagnosis, 90-day mRS, and incidence of intracranial hemorrhage; and adjusted for age, admission NIHSS, pre-stroke mRS and diabetes in multivariable models. Results We identified 106 patients; 74 IPS patients and 32 INS patients, who had similar baseline characteristics, except for baseline NIHSS (IPS 12.9±8.2, INS 8.0±5.6, p=0.002) and incidence of cardiac arrhythmias (IPS 32.4%, INS 12.5%, p=0.034). The diagnoses in the INS group were stroke (23, 72%) – representing NNCI, somatization (6, 19%), tumor (1, 3%), seizure (1, 3%), and migraine (1, 3%). All IPS patients were diagnosed with acute ischemic stroke. Adjusted for age, baseline NIHSS, pre-stroke mRS and diabetes, the INS patients had significantly higher rates (OR 3.04, p=0.036) of good functional outcome (90 day mRS 0–1). ICH was found in 24% of the IPS patients and was symptomatic in 6.8%. None of the INS patients had ICH. Conclusions Since the majority of INS patients were found to have neuroimaging negative cerebral ischemia (NNCI), which may represent either TIA or aborted stroke, and there were no intracerebral hemorrhages in the INS group, our data support the safety of administering IV tissue plasminogen activator to all patients in whom acute ischemic stroke is clinically suspected. We have demonstrated that NNCI patients and stroke mimics are common and future larger scale prospective studies are required to delineate the true frequencies of each, and to evaluate differences in outcomes.

Background and Purpose The objective of this pooled analysis was to determine level of agreement between central read and each of two groups (spoke radiologists and hub vascular neurologists) in interpreting head computed tomography (CT) scans of stroke patients presenting to telestroke network hospitals. Methods The Stroke Team Remote Evaluation Using a Digital Observation Camera (STRokE DOC and STRokE DOC-AZ TIME) trials were prospective, randomized, outcome-blinded trials comparing telemedicine and teleradiology to telephone-only consultations. In each trial, the subjects’ CT scans were interpreted by the hub vascular neurologist in the telemedicine arm, and by the spoke radiologist in the telephone arm. We obtained a central read for each CT using adjudicating committees blinded to treatment arm and outcome. The data were pooled and results reported for the entire population. Kappa statistics and exact agreement rates were used to assess interobserver agreement for radiographic contraindication to recombinant tissue plasminogen activator (rt-PA), presence of hemorrhage, tumor, hyperdense artery, acute stroke, prior stroke, and early ischemic changes. Results Among 261 analyzed cases, the agreement with central read for presence of radiological rt-PA contraindication was excellent for hub vascular neurologist (96.2%, κ=0.81, 95%CI 0.64–0.97), spoke radiologist report (94.7%, κ=0.64, 95%CI 0.39–0.88), and overall (95.4%, κ=0.74, 95%CI 0.59–0.88). For rt-PA treated patients (N=65), overall agreement was 98.5%, and vascular neurologist agreement with central read was 100%. Conclusions Both vascular neurologists and reports from spoke radiologists had excellent reliability in identifying radiologic rt-PA contraindications. These pooled findings demonstrate that telestroke evaluation of head CT scans for acute rt-PA assessments is reliable.