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LONG-TERM REMOTE ISCHEMIC CONDITIONING IN PATIENTS WITH ISCHEMIC STROKE – A RANDOMIZED CONTROLLED CROSS-OVER TRIAL
Abstract
Background and Aims
Remote ischemic conditioning (RIC) may have neuroprotective effects. Immediate or long-term RIC may increase cerebral blood flow velocity and cerebrovascular reactivity in patients with ischemic stroke.
Methods
We included patients with cerebral small vessel occlusion stroke in a randomized controlled, open-label, outcome-blinded, cross-over pilot study, with two weeks daily RIC treatment (four cycles of five minutes) and two weeks observation, intersected by three weeks wash-out. At baseline and after each period mean cerebral blood flow velocity in the middle cerebral artery (VMCA) was assessed by transcranial doppler and blood oxygen saturation in the cerebral microvasculature (ScO2) by near infrared spectroscopy (NIRS) at rest, during RIC and finger tapping. Blood pressure (BP) and ankle brachial index (ABI) were recorded. Cognitive function and modified Rankin Score were assessed at baseline.
Results
14 patients, mean age 71±8.1 years, 21% women, NIHSS on admission 3±3.2. Baseline mean values ± SD were; MOCA 26±2.3, VMCA 48.8±8.5 cm/sec, ScO2 68.3±5.7, BP 137/80±18/8 mmHg, ABI 1.08±0.1. VMCA (p=0.50) or ScO2 (p=0.25) did not change during RIC or after each period (p=0.28/p=0.53, VMCA/ScO2 respectively). Finger tapping increased VMCA mean by 4.13% ±6.31 (p=0.029) and ScO2 mean by 0.37% ±0.50 (p=0.02), with no excess change between periods (p=0.9 and 0.96). No change in BP (p=0.68) or ABI (p=0.53).
Conclusions
Cerebrovascular response remained unchanged during RIC and after two weeks daily RIC. RIC did no change peripheral vascular response. More sensitive methods of measuring cerebral blood flow should be applied to evaluate if RIC may improve vascular outcome after ischemic stroke.
CHARACTERISTICS OF ISCHEMIC WAKE-UP STROKE AND UNKOWN-ONSET STROKE IN THE NATIONWIDE NORWEGIAN STROKE REGISTER
Abstract
Background and Aims
Previous studies indicate that patients with wake-up stroke (WUS) are similar to patients with known onset stroke (KOS), but may differ from patients with unknown-onset stroke (UOS). We compared risk factors and clinical characteristics in patients with ischemic WUS, UOS, and KOS from a large national stroke register.
Methods
We included patients registered in the Norwegian Stroke Register from 2012 to 2019. Information on age, gender, risk factors, medication and clinical characteristics were compared between patients with ischemic WUS, UOS and KOS.
Results
Of the 52 134 ischemic strokes, 19.8 % were WUS and 17.7% UOS. Patients with UOS were older (76.6 years, SD 12.6) than patients with WUS (73.6, SD 13.0) and KOS (73.5, SD 13.5). A higher proportion were women (50.3% vs. 43.0% in WUS and 44.8% in KOS) and lived alone (52.5% in the OUS group vs. 36.6% in both WUS and KOS groups). After adjustment for age and sex, atrial fibrillation was more frequent among UOS patients. Other cerebrovascular risk factors did not substantially differ between groups. WUS patients had milder strokes compared to UOS and KOS, while more UOS patients had NIHSS > 15 and reduced level of consciousness on admission.
Conclusions
WUS patients shared baseline characteristics with KOS, but tended to have milder strokes. UOS patients were older and larger proportions were women, lived alone, had atrial fibrillation and severe strokes compared to WUS and KOS patients. The results indicate that WUS and UOS should be considered separate entities.
ONGOING CLINICAL TRIAL: A PROSPECTIVE MULTICENTRE, PHASE 2B RANDOMISED, CONTROLLED DOUBLE-BLIND TRIAL TO DETERMINE THE SAFETY AND EFFICACY OF PERISPINAL ETANERCEPT ON QUALITY OF LIFE
Abstract
Background and Aims
There are few treatment options for stroke survivors with ongoing impairments. Recently, the beneficial effects of a tumor necrosis factor inhibitor, etanercept, has caught the attention of the media and the stroke survivor community. Observational, uncontrolled studies suggest substantial improvements of chronic impairments after a single administration of etanercept, injected subcutaneously in the perispinal region. Large, randomized controlled trials have not been conducted.
Methods
The Perispinal Etanercept for STroke Outcomes trial (ACTRN12620001011976) is a 30-months, phase 2b, multicenter, randomized, double blind, placebo-controlled trial testing the safety and efficacy of administration of perispinal etanercept in improving patient reported outcomes at 28 days after treatment. The required sample size is 168. Eligible patients are aged ≤65 years at time of stroke, between 1-5 year after the index stroke, with a current modified Rankin scale of 3 to 5. The primary efficacy hypothesis is that treatment with perispinal etanercept improves quality of life in stroke survivors, as measured with the Short Form-36. The secondary hypothesis is that repeated injection of etanercept leads to improved quality of life compared to a single injection. Other exploratory outcome measures include the NIHSS, MOCA, FIM, modified Rankin scale, pain VAS, FAS, PHQ-9, GAD-7.
Results
The trial is ongoing with 36 patients enrolled as of May 14 2021 at sites in Australia and New Zealand.
Conclusions
The promise of etanercept to improve quality of life in chronic stroke survivors needs to be tested. PESTO will inform the stroke community about the efficacy and safety of this intervention.
SAFETY AND EFFICACY OF LT3001 IN PATIENTS WITH ACUTE ISCHEMIC STROKE WITHIN 24 HOURS AFTER SYMPTOMS ONSET: A PHASE 2, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY
Abstract
Background and Aims
LT3001, a novel small molecule, designed to simultaneously act as a thrombolytic and reduce reperfusion injury, has been shown safe and efficacious in multiple animal stroke models. Here we assessed the safety of LT3001 in acute ischemic stroke patients within 24 hours after symptoms onset.
Methods
Eligible patients were last-known-normal ≤24h, had a NIHSS 4-30 and were not treated with IV-tPA and/or endovascular thrombectomy. Participants were 2:1 randomly assigned to receive a single dose of LT3001 or placebo. The primary outcome was the sICH rate ≤36h. Secondary outcomes included neurological/ functional outcome measures, mortality and other adverse events by Day-90 (NCT04091945).
Results
Twenty-four participants (16 in LT3001 group and 8 in placebo group) were enrolled at 10 centers in the US and Taiwan. Participants in the LT3001 and placebo groups were age of 62±13 and 68±9 years with median NIHSS of 6 (Range 4-24) and 5 (Range 4-17), respectively. Median times from onset-to-treatment were 21-hours for LT3001 and 18.5-hours for placebo. No sICH occurred and other safety measures appeared comparable between groups. Excellent functional outcome (90-day mRS(0-1)) was achieved in 3 (21%) LT3001 and 1 (14%) placebo-treated participants. Major neurological improvement (≥4-points NIHSS improvement from baseline to Day-30) occurred in 7 (47%) LT3001 and 1 (14%) placebo-treated participants. Among the 9 participants with baseline NIHSS≥6 treated with LT3001, 7 (78%) showed major neurological improvement.
Conclusions
Treatment with LT3001 within 24 hours after ischemic stroke onset appears to be safe and may be associated with better neurological and functional outcomes.
ISCHEMIC STROKE SUBTYPES: A COMPARISON BETWEEN CAUSATIVE AND PHENOTYPIC CLASSIFICATIONS IN A TERTIARY HOSPITAL IN THE PHILIPPINES
Abstract
Background and Aims
Currently, there is no local data for stroke subtyping in the Philippines. The most widely used classification is the Trial of Org 10172 in Acute Stroke Treatment (TOAST) with 5 subtypes; in contrast, ASCO classification is a phenotypic classification and assigns each patient under four predefined phenotypes, with each graded depending on the evidence present.
Methods
Retrospective cross-sectional analytical study including all adult patients admitted January 1 to December 31, 2019, with a diagnosis of ischemic stroke. Data was collected through electronic medical chart review and hand search. The first 50 patients were independently classified by the researcher and a neurologist to assess concordance. 
Results
519 patients, mean age 63.4, with more females than males (51 vs. 48%). Stroke subtypes distribution for both systems (TOAST, ASCO) were similar: small vessel disease/lacunar (52.9%, 47.5%), cardioembolic (16.3%, 18.5%), large-artery atherosclerosis (10%, 11.7%), other causes (0.39%, 0.58%). Concordance was substantial to almost perfect agreement (K = 0.78 - 0.91) except in the undetermined category. There was a significant decrease in the undetermined (cryptogenic) subtype when ASCO was used (9.0% vs. 20.2%). Furthermore, of 105 cryptogenic cases using TOAST, almost half of these (52) yielded distinct etiologies when using ASCO. Overall, a total of 211 patients (40.6%) had concomitant etiologies under ASCO.
Conclusions
Subtypes of stroke were: small vessel disease (52.9%), cardioembolic (16.3%), large artery atherosclerosis (10%), other causes (0.39%). ASCO classification had good concordance with the TOAST, but ASCO was superior in reducing undetermined or cryptogenic subtypes and detecting concomitant etiologies.