Abstract P132: Successful Conduct of an Acute Stroke Clinical Trial During COVID

Stroke ◽  
2021 ◽  
Vol 52 (Suppl_1) ◽  
Author(s):  
James C Grotta ◽  
Stephanie Parker ◽  
Asha Jacob ◽  
ritvij bowry ◽  
Patti Bratina ◽  
...  
Keyword(s):  
Clinical Research ◽  
Acute Stroke ◽  
Hospital Setting ◽  
Discharge Disposition ◽  
Patient Demographics ◽  
Standard Management ◽  
Serious Infection ◽  
Study Staff ◽  
Personnel Safety ◽  
The Impact

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.

scholarly journals Successful conduct of an acute stroke clinical trial during COVID

PLoS ONE ◽  
2021 ◽  
Vol 16 (1) ◽  
pp. e0243603
Author(s):  
Jose-Miguel Yamal ◽  
Stephanie A. Parker ◽  
Asha P. Jacob ◽  
Suja S. Rajan ◽  
Ritvij Bowry ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Research ◽  
Acute Stroke ◽  
Hospital Setting ◽  
Hospital Length ◽  
Hospital Length Of Stay ◽  
Trial Conduct ◽  
Discharge Disposition ◽  
Patient Demographics ◽  
The Impact

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 acute stroke clinical trial conduct at sites that continued to enroll patients during the pandemic. 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 technologist, paramedics and emergency medicine technicians on-board. During COVID, consent, 90-day modified Rankin Scale (mRS) and EQ5D were obtained by phone instead of in-person, but other aspects of management were similar to the pre-COVID period. We compared patient demographics, study metrics, and infection of study personnel during intra- vs pre-COVID eras. Five of 6 BEST-MSU sites continued to enroll during COVID. There were no differences in intra- (n = 57) vs pre- (n = 869) COVID enrolled tPA eligible patients’ age, sex, race (38.6% vs 38.0% Black), ethnicity (15.8% vs 18.6% Hispanic), or NIHSS (median 11 vs 9). The percent of screened patients enrolled and adjudicated tPA eligible declined from 13.6% to 6.6% (p < .001); study enrollment correlated with local stay-at-home and reopening orders. There were no differences in alert to MSU arrival or arrival to tPA times, but MSU on-scene time was 5 min longer (p = .01). There were no differences in ED door to CT, tPA treatment or thrombectomy puncture times, hospital length of stay, discharge disposition, or remote vs in-person 90-day mRS or EQ5D. One MSU nurse tested positive but did not require hospitalization. Clinical research in the pre-hospital setting can be carried out accurately and safely during a pandemic. tPA eligibility rates declined, but otherwise there were no differences in patient demographics, deterioration of study processes, or serious infection of study staff. Trial registration: NCT02190500

Abstract WP184: The Road to Recovery Stroke Support Group: A Feasibility Assessment of an Inpatient Multi-Disciplinary Stroke Support Group

Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Jade Ann V Diaz ◽  
Lorina Punsalang ◽  
Alvina Mkrtumyan ◽  
Denise Gaffney ◽  
Qiana Hines ◽  
...  
Keyword(s):  
Support Group ◽  
Recurrent Stroke ◽  
Skilled Nursing Facility ◽  
Hospital Setting ◽  
Knowledge Retention ◽  
Discharge Data ◽  
The Road ◽  
Discharge Disposition ◽  
Recovery Stroke ◽  
The Impact

Background: Stroke is life changing for both patients and caregivers. Recovery from stroke affects the physical, social and emotional aspects of life. Transitioning to a new normal should begin immediately after stroke, ideally during hospital admission. Most support groups exist outside of the hospital setting and begin weeks to months after the ictus. The Road to Recovery Stroke Support Group (RRSSG) was created to bridge the gap between the inpatient and outpatient setting. Purpose: RRSSG aims to provide a weekly platform for stroke survivors and caregivers in an in-hospital setting. During sessions, attendees learn about types of challenges after stroke, rehabilitation services available to them and what to expect after leaving the hospital. Patients can return to the same support group once discharged from the hospital. Methods: RRSSG was launched in November 2018. Candidates for the weekly RRSSG meeting were identified by nurses and the stroke case manager. Meetings were facilitated by a stroke survivor volunteer, case management and physical and social medicine. Invitations were extended to patients and their caregivers prior to discharge. Data were collected for 7 months and analyzed for the following: patient demographics, types of stroke and discharge disposition. Results: During the 7-month period, 514 patients were discharged with a stroke diagnosis, 24.3% of which attended the RRSSG. The demographics were 53.7% women with a median age of 66 years; 33.1% White/European, 36% Hispanic/Latino, 18.0% African American, 10.8% Asian, and 2.1% other. 61.6% had an ischemic stroke, 30.4% had an intracerebral hemorrhage, 11.2% had a subarachnoid hemorrhage. More patients who attended RRSSG were discharged to an acute rehabilitation hospital (6.5% RRSG vs. 1.8% non-RRSG, p=0.04). There was no difference in those discharged to: home (54.0% RRSSG vs. 55.5% non-RRSSG) and skilled nursing facility (27.3% RRSSG vs. 20.1% non-RRSSG). Conclusion: Creating and sustaining an inpatient multi-disciplinary stroke support group on a weekly basis is feasible. The future goals are to assess the impact of the in-hospital support group on stroke knowledge retention, medication compliance, post-stroke depression, recurrent stroke and re-admission rates.

Abstract P77: Acute Stroke Trends and Outcomes During the COVID-19 Pandemic in a Multi-System Hospital System in the Western US

Stroke ◽  
2021 ◽  
Vol 52 (Suppl_1) ◽  
Author(s):  
Renee Ovando ◽  
Natalie R Swearingen ◽  
Tamela L Stuchiner ◽  
Leslie Corless ◽  
Crystal Ann Moreno ◽  
...  
Keyword(s):  
Acute Stroke ◽  
Performance Metrics ◽  
Systems Of Care ◽  
Statistical Significance ◽  
Acute Stroke Care ◽  
Hospital System ◽  
Discharge Disposition ◽  
Western Us ◽  
First Pass ◽  
The Impact

Introduction: We aimed to evaluate the impact of Covid-19 pandemic on stroke systems of care and outcomes within a large multi-hospital system in the Western US. Methods: Retrospective data from 37 hospitals within a large multi-hospital stroke registry was analyzed. All patients with a confirmed discharge diagnosis of stroke or TIA during the pandemic (March and April 2020) were compared to cohorts during the same periods in 2018 and 2019. Analyzed factors included demographics, stroke mechanism, admission NIHSS, reperfusion therapy rates (IV TPA and EVT), reperfusion performance metrics (door-to-CT, door-to-needle, door-to-puncture, door-to-first pass), TICI score, discharge and 90-day mRS, discharge disposition, and length of stay. Analyses were conducted using ANOVA, Kruskal-Wallis, or Person’s Chi-square test, as appropriate, adjusting for multiple comparisons. Results: Among the 7,201 analyzed patients, 2,378 (33.0%) were admitted in 2018, 2,613 (36.3%) in 2019 and 2,210 (30.7%) in 2020. Fewer patients were hospitalized with TIA during the pandemic compared to 2018 and 2019 (23.6% vs 36.8% vs 39.6%, p<.001). More patients arrived via EMS (52.2% vs 45.7% vs 45.4 %) and fewer via private car (29.8% vs 37.8% vs 38.7%) (p<.001) during the pandemic. Median door-to-CT (in minutes) (26 vs 35 vs 33, p<.001) time was significantly shorter during the pandemic. Additionally, a greater percentage of patients were treated with EVT during the pandemic (7.5 vs 5.7 vs 5.4, p=.005). Shorter arrival-to-first pass times (in minutes) occurred in 2020 compared to previous years (103 vs 119 vs 115, p=0.091) but this difference did not reach statistical significance. Fewer patients were discharged to a skilled nursing facility during the pandemic (12.7%) compared to 2018 and 2019 (15.1% and 15.2%, p=.012). There were no other significant differences in stroke admission volumes, treatment trends, or outcomes between the pandemic and pre-pandemic periods. Conclusion: Fewer walk-in strokes and TIAs were hospitalized during the pandemic while an increased rate of thrombectomy procedures occurred compared to the pre-pandemic era. Despite anticipated delays in acute stroke care, our study demonstrates improvement in key triage and treatment times and similar outcomes.

Abstract WP317: The Impact of Post-acute Discharge Disposition on Outcomes in the SWIFT PRIME Trial

Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Samir R Belagaje ◽  
Diogo C Haussen ◽  
Jeffrey L Saver ◽  
Mayank Goyal ◽  
David S Liebeskind ◽  
...  
Keyword(s):  
Acute Stroke ◽  
Skilled Nursing Facility ◽  
Inpatient Rehabilitation ◽  
Stroke Care ◽  
Favorable Outcome ◽  
Stroke Severity ◽  
Acute Stroke Care ◽  
Stroke Treatment ◽  
Discharge Disposition ◽  
The Impact

Intro: Post-acute stroke care in an inpatient rehabilitation facility (IRF) demonstrates better outcomes compared to a skilled nursing facility (SNF). With advancements in endovascular acute stroke, the impact that post-acute care plays is unclear. Here, we analyze a successful endovascular acute stroke trial to demonstrate that more improvement is seen in patients discharged to an IRF compared to a SNF. Methods: From SWIFT PRIME, a prospective, multi-center randomized acute endovascular trial, subject characteristics, and modified Rankin scores (mRS) were obtained. Post-acute hospital discharge was classified as home, IRF, and SNF. A favorable outcome was defined as 90 day mRS ≤ 2 and improvement was defined as ≥ 1 point decrease in mRS score. The effect of each disposition on a favorable outcome was calculated overall and stratified by stroke severity class (defined as discharge mRS 0-3, 4, 5) Results: A total of 165 subjects (mean age 64.8 years, mean initial NIHSS= 16.5, and 50 % male) were analyzed. Discharge disposition included: 51 (31%) going home, 92 (56%) IRF, 22 (13%) SNF. The baseline characteristics were similar between patients that went to IRF and SNF: age (p =0.76), gender (p= 0.81), baseline NIHSS (p=0.055), final infarct volumes (p=0.20), and recanalization rates (p=0.19). However, IRF subjects had lower NIHSS (p<0.001) and mRS (p=0.017) at day 7. Time to treatment defined as symptom onset to groin puncture was not significantly associated with discharge disposition (p=0.119). Only 1/22 (4.5%) subjects who were discharged to SNF achieved a 90 day mRS ≤2, compared to 41/92 (44.6%) in the IRF group or 48/51 (94.1%) in the home group (p < 0.001). When stratified by stroke severity: for mRS=0-3, there were no differences in favorable outcomes; mRS=4, 1/7 (14.3%) showed improvement at SNF compared to 21/27 (77.8%) at IRF (p=0.008); mRS =5, 5/14 (35.7%) showed improvement at SNF compared to 28/37 (75.7%) at IRF (p=0.013). Conclusions: Despite having similar characteristics following acute stroke treatment, not only did subjects who went to SNF compared to IRF have more unfavorable outcomes, they were less likely to make improvement. These findings show the continued importance of post-stroke rehabilitation, even in the endovascular era.

scholarly journals Impact of transfer status on hospitalization cost and discharge disposition for acute ischemic stroke across the US

2016 ◽  
Vol 124 (5) ◽  
pp. 1228-1237 ◽  
Author(s):  
Ashish Sonig ◽  
Ning Lin ◽  
Chandan Krishna ◽  
Sabareesh K. Natarajan ◽  
Maxim Mokin ◽  
...  
Keyword(s):  
Regression Analysis ◽  
Acute Stroke ◽  
Univariate Analysis ◽  
Stroke Patients ◽  
Hospitalization Cost ◽  
Discharge Disposition ◽  
Intravenous Tissue Plasminogen Activator ◽  
Hospital Factors ◽  
Transferred Patients ◽  
The Impact

OBJECT In this study, the authors used information provided in the Nationwide Inpatient Sample (NIS) to study the impact of transferring stroke patients from one facility to a center where they received some form of active stroke intervention (intravenous tissue plasminogen activator, thrombectomy, or a combination of both therapies). METHODS Patient demographic characteristics and hospital factors obtained from the 2008–2010 acute stroke NIS data were analyzed. Discharge disposition, hospitalization cost, and mortality were the dependent variables studied. Univariate analysis and multivariate binary logistic regression analysis were performed. Data analysis focused on the cohort of acute stroke patients who received some form of active intervention (55,913 of 1,311,511 patients in the NIS). RESULTS When overall outcome was considered, transferred patients had a significantly higher number of other-than-routine (OTR, i.e., other than discharge to home without home health care) discharge dispositions (p < 0.0001). In multivariate regression analysis including pertinent patient and hospital factors, transfer-in patients had significantly worse OTR discharge disposition (p < 0.0001, odds ratio [OR] 2.575, 95% CI 2.341–2.832). Mean hospitalization cost including an intervention was $70,325.11 for direct admissions and $97,546.92 for transferred patients. Transfer from another facility (p < 0.001, OR 1.677, 95% CI 1.548–1.817) was associated with higher hospitalization cost. CONCLUSIONS The study showed that hospital cost for acute stroke intervention is significantly higher for a transferred patient than for a direct admission. Moreover, the frequency of OTR discharge was significantly higher among transferred patients than direct admissions. Future strategies should focus on ways and means of transporting patients appropriately and directly to stroke centers.

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 ◽  
...  
Keyword(s):  
Los Angeles ◽  
Clinical Outcome ◽  
Acute Stroke ◽  
Clinical Outcomes ◽  
Hospital Setting ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Excellent Outcome ◽  
Neurological Improvement ◽  
Discharge Disposition

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.

scholarly journals Bottlenecks in the Acute Stroke Care System during the COVID-19 Pandemic in Catalonia

2021 ◽  
pp. 1-9
Author(s):  
Anna Ramos-Pachón ◽  
Álvaro García-Tornel ◽  
Mònica Millán ◽  
Marc Ribó ◽  
Sergi Amaro ◽  
...  
Keyword(s):  
Acute Stroke ◽  
Functional Outcome ◽  
Stroke Care ◽  
Care Quality ◽  
Point Of View ◽  
Stroke Severity ◽  
Acute Stroke Care ◽  
Vessel Occlusion ◽  
Prehospital Delays ◽  
The Impact

<b><i>Introduction:</i></b> The COVID-19 pandemic resulted in significant healthcare reorganizations, potentially striking standard medical care. We investigated the impact of the COVID-19 pandemic on acute stroke care quality and clinical outcomes to detect healthcare system’s bottlenecks from a territorial point of view. <b><i>Methods:</i></b> Crossed-data analysis between a prospective nation-based mandatory registry of acute stroke, Emergency Medical System (EMS) records, and daily incidence of COVID-19 in Catalonia (Spain). We included all stroke code activations during the pandemic (March 15–May 2, 2020) and an immediate prepandemic period (January 26–March 14, 2020). Primary outcomes were stroke code activations and reperfusion therapies in both periods. Secondary outcomes included clinical characteristics, workflow metrics, differences across types of stroke centers, correlation analysis between weekly EMS alerts, COVID-19 cases, and workflow metrics, and impact on mortality and clinical outcome at 90 days. <b><i>Results:</i></b> Stroke code activations decreased by 22% and reperfusion therapies dropped by 29% during the pandemic period, with no differences in age, stroke severity, or large vessel occlusion. Calls to EMS were handled 42 min later, and time from onset to hospital arrival increased by 53 min, with significant correlations between weekly COVID-19 cases and more EMS calls (rho = 0.81), less stroke code activations (rho = −0.37), and longer prehospital delays (rho = 0.25). Telestroke centers were afflicted with higher reductions in stroke code activations, reperfusion treatments, referrals to endovascular centers, and increased delays to thrombolytics. The independent odds of death increased (OR 1.6 [1.05–2.4], <i>p</i> 0.03) and good functional outcome decreased (mRS ≤2 at 90 days: OR 0.6 [0.4–0.9], <i>p</i> 0.015) during the pandemic period. <b><i>Conclusion:</i></b> During the COVID-19 pandemic, Catalonia’s stroke system’s weakest points were the delay to EMS alert and a decline of stroke code activations, reperfusion treatments, and interhospital transfers, mostly at local centers. Patients suffering an acute stroke during the pandemic period had higher odds of poor functional outcome and death. The complete stroke care system’s analysis is crucial to allocate resources appropriately.

scholarly journals THU0528 NAILFOLD VIDEOCAPILLAROSCOPY REPORTING IN CLINICAL RESEARCH: INTERNATIONAL DELPHI BASED CONSENSUS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 503.1-504
Author(s):  
F. Ingegnoli ◽  
T. Schioppo ◽  
A. Herrick ◽  
A. Sulli ◽  
F. Bartoli ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Research ◽  
Rheumatic Diseases ◽  
Unmet Need ◽  
Future Research ◽  
Invasive Technique ◽  
Delphi Consensus ◽  
Research Support ◽  
The Impact ◽  
Research Studies

Background:Nailfold capillaroscopy (NVC), a non-invasive technique to assess microcirculation, is increasingly being incorporated into rheumatology routine clinical practice. Currently, the degree of description of NVC methods varies amongst research studies, making interpretation and comparison between studies challenging. In this field, an unmet need is the standardization of items to be reported in research studies using NVC.Objectives:To perform a Delphi consensus on minimum reporting standards in methodology for clinical research, based on the items derived from a systematic review focused on this topic.Methods:The systematic review of the literature on NVC methodology relating to rheumatic diseases was performed according to PRISMA guidelines (PROSPERO CRD42018104660) to July 22nd2018 using MEDLINE, Embase, Scopus. Then, a three-step web-based Delphi consensus was performed in between members of the EULAR study group on microcirculation in rheumatic diseases and the Scleroderma Clinical Trials Consortium. Participants were asked to rate each item from 1 (not appropriate) to 9 (completely appropriate).Results:In total, 3491 references were retrieved in the initial search strategy, 2862 were excluded as duplicates or after title/abstract screening. 632 articles were retrieved for full paper review of which 319 fulfilled the inclusion criteria. Regarding patient preparation before the exam, data were scarce: 38% reported acclimatization, 5% to avoid caffeine and smoking, 3% to wash hands and 2% to avoid manicure. Concerning the device description: 90% reported type of instrument, 77% brand/model, 72% magnification, 46% oil use, 40% room temperature and 35% software for image analysis. As regards to examination details: 76% which fingers examined, 75% number of fingers examined, 15% operator experience, 13% reason for finger exclusion, 9% number of images, 8% quality check of the images and 3% time spent for the exam. Then, a three-round Delphi consensus on the selected items was completed by 80 participants internationally, from 31 countries located in Australia, Asia, Europe, North and South America. Some items reached the agreement at the second round (85 participants), and other items were suggested as important to consider in a future research agenda (e.g. temperature for acclimatization, the impact of smoking, allergies at the application of the oil to the nailbed, significance of pericapillary edema, methods of reporting hemorrhages, ramified and giant capillaries). The final agreement results are reported below:Conclusion:On the basis of the available literature the description of NVC methods was highly heterogeneous and individual published studies differed markedly. These practical suggestions developed using a Delphi process among international participants provide a guidance to improve and to standardize the NVC methodology in future clinical research studies.Disclosure of Interests:Francesca Ingegnoli: None declared, Tommaso Schioppo: None declared, Ariane Herrick: None declared, Alberto Sulli Grant/research support from: Laboratori Baldacci, Francesca Bartoli: None declared, Nicola Ughi: None declared, John Pauling: None declared, Maurizio Cutolo Grant/research support from: Bristol-Myers Squibb, Actelion, Celgene, Consultant of: Bristol-Myers Squibb, Speakers bureau: Sigma-Alpha, Vanessa Smith Grant/research support from: The affiliated company received grants from Research Foundation - Flanders (FWO), Belgian Fund for Scientific Research in Rheumatic diseases (FWRO), Boehringer Ingelheim Pharma GmbH & Co and Janssen-Cilag NV, Consultant of: Boehringer-Ingelheim Pharma GmbH & Co, Speakers bureau: Actelion Pharmaceuticals Ltd, Boehringer-Ingelheim Pharma GmbH & Co and UCB Biopharma Sprl

scholarly journals Effect of early sleep apnoea treatment with adaptive servo-ventilation in acute stroke patients on cerebral lesion evolution and neurological outcomes: study protocol for a multicentre, randomized controlled, rater-blinded, clinical trial (eSATIS: early Sleep Apnoea Treatment in Stroke)

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Simone B. Duss ◽  
Anne-Kathrin Brill ◽  
Sébastien Baillieul ◽  
Thomas Horvath ◽  
Frédéric Zubler ◽  
...  
Keyword(s):  
Magnetic Resonance Imaging ◽  
Magnetic Resonance ◽  
Acute Stroke ◽  
Acute Ischaemic Stroke ◽  
Sleep Apnoea ◽  
Resonance Imaging ◽  
Stroke Patients ◽  
Adaptive Servo Ventilation ◽  
Randomized Controlled ◽  
The Impact

Abstract Background Sleep-disordered breathing (SDB) is highly prevalent in acute ischaemic stroke and is associated with worse functional outcome and increased risk of recurrence. Recent meta-analyses suggest the possibility of beneficial effects of nocturnal ventilatory treatments (continuous positive airway pressure (CPAP) or adaptive servo-ventilation (ASV)) in stroke patients with SDB. The evidence for a favourable effect of early SDB treatment in acute stroke patients remains, however, uncertain. Methods eSATIS is an open-label, multicentre (6 centres in 4 countries), interventional, randomized controlled trial in patients with acute ischaemic stroke and significant SDB. Primary outcome of the study is the impact of immediate SDB treatment with non-invasive ASV on infarct progression measured with magnetic resonance imaging in the first 3 months after stroke. Secondary outcomes are the effects of immediate SDB treatment vs non-treatment on clinical outcome (independence in daily functioning, new cardio-/cerebrovascular events including death, cognition) and physiological parameters (blood pressure, endothelial functioning/arterial stiffness). After respiratory polygraphy in the first night after stroke, patients are classified as having significant SDB (apnoea-hypopnoea index (AHI) > 20/h) or no SDB (AHI < 5/h). Patients with significant SDB are randomized to treatment (ASV+ group) or no treatment (ASV− group) from the second night after stroke. In all patients, clinical, physiological and magnetic resonance imaging studies are performed between day 1 (visit 1) and days 4–7 (visit 4) and repeated at day 90 ± 7 (visit 6) after stroke. Discussion The trial will give information on the feasibility and efficacy of ASV treatment in patients with acute stroke and SDB and allows assessing the impact of SDB on stroke outcome. Diagnosing and treating SDB during the acute phase of stroke is not yet current medical practice. Evidence in favour of ASV treatment from a randomized multicentre trial may lead to a change in stroke care and to improved outcomes. Trial registration ClinicalTrials.gov NCT02554487, retrospectively registered on 16 September 2015 (actual study start date, 13 August 2015), and www.kofam.ch (SNCTP000001521).

scholarly journals COVID-19 Pathogenesis: From Molecular Pathway to Vaccine Administration

Biomedicines ◽  
2021 ◽  
Vol 9 (8) ◽  
pp. 903
Author(s):  
Francesco Nappi ◽  
Adelaide Iervolino ◽  
Sanjeet Singh Avtaar Singh
Keyword(s):  
Hospital Setting ◽  
Pathophysiological Mechanism ◽  
Systemic Response ◽  
Respiratory Complications ◽  
Thrombotic Risk ◽  
Global Pandemic ◽  
The Impact ◽  
Multiple Variants ◽  
Roll Out

The Coronavirus 2 (SARS-CoV-2) infection is a global pandemic that has affected millions of people worldwide. The advent of vaccines has permitted some restitution. Aside from the respiratory complications of the infection, there is also a thrombotic risk attributed to both the disease and the vaccine. There are no reliable data for the risk of thromboembolism in SARS-CoV-2 infection in patients managed out of the hospital setting. A literature review was performed to identify the pathophysiological mechanism of thrombosis from the SARS-CoV-2 infection including the role of Angiotensin-Converting Enzyme receptors. The impact of the vaccine and likely mechanisms of thrombosis following vaccination were also clarified. Finally, the utility of the vaccines available against the multiple variants is also highlighted. The systemic response to SARS-CoV-2 infection is still relatively poorly understood, but several risk factors have been identified. The roll-out of the vaccines worldwide has also allowed the lifting of lockdown measures and a reduction in the spread of the disease. The experience of the SARS-CoV-2 infection, however, has highlighted the crucial role of epidemiological research and the need for ongoing studies within this field.

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