scholarly journals National Institutes of Health Stroke Scale

Stroke ◽  
2020 ◽  
Vol 51 (1) ◽  
pp. 282-290 ◽  
Author(s):  
Vicky Chalos ◽  
Nadinda A.M. van der Ende ◽  
Hester F. Lingsma ◽  
Maxim J.H.L. Mulder ◽  
Esmee Venema ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Endovascular Treatment ◽  
Treatment Effect ◽  
Acute Treatment ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Primary Outcome Measure ◽  
National Institutes Of Health ◽  
Unique Identifier ◽  
Mr Clean

Background and Purpose— The modified Rankin Scale (mRS) at 3 months is the most commonly used primary outcome measure in stroke treatment trials, but it lacks specificity and requires long-term follow-up interviews, which consume time and resources. An alternative may be the National Institutes of Health Stroke Scale (NIHSS), early after stroke. Our aim was to evaluate whether the NIHSS assessed within 1 week after treatment could serve as a primary outcome measure for trials of acute treatment for ischemic stroke. Methods— We used data from 2 randomized controlled trials of endovascular treatment for ischemic stroke: the positive MR CLEAN (Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands; N=500) and the neutral IMS (Interventional Management of Stroke) III trial (N=656). We used a causal mediation model, with linear and ordinal logistic regression adjusted for confounders, to evaluate the NIHSS 24 hours and 5 to 7 days after endovascular treatment as primary outcome measures (instead of the mRS at 3 months) in both trials. Patients who had died before the NIHSS was assessed received the maximum score of 42. NIHSS+1 was then log10-transformed. Results— In both trials, there was a significant correlation between the NIHSS at 24 hours and 5 to 7 days and the mRS. In MR CLEAN, we found a significant effect of endovascular treatment on the mRS and on the NIHSS at 24 hours and 5 to 7 days. After adjustment for NIHSS at 24 hours and 5 to 7 days, the effect of endovascular treatment on the mRS decreased from common odds ratio 1.68 (95% CI, 1.22–2.32) to respectively 1.36 (95% CI, 0.97–1.91) and 1.24 (95% CI, 0.87–1.79), indicating that treatment effect on the mRS is in large part mediated by the NIHSS. In the IMS III trial there was no treatment effect on the NIHSS at 24 hours and 5 to 7 days, corresponding with the absence of a treatment effect on the mRS. Conclusions— The NIHSS within 1 week satisfies the requirements for a surrogate end point and may be used as a primary outcome measure in trials of acute treatment for ischemic stroke, particularly in phase II(b) trials. This could reduce stroke-outcome assessment to its essentials (ie, neurological deficit), and reduce trial duration and costs. Whether and under which conditions it could be used in phase III trials requires a debate in the field with all parties. Clinical Trial Registration— URL: http://www.isrctn.com . Unique identifier: ISRCTN10888758; https://www.clinicaltrials.gov . Unique identifier: NCT00359424.

Abstract TMP6: NIH Stroke Scale as the Primary Outcome Measure for Trials of Acute Treatment of Ischemic Stroke

Stroke ◽  
2019 ◽  
Vol 50 (Suppl_1) ◽  
Author(s):  
Vicky Chalos ◽  
Nadinda van der Ende ◽  
Hester F Lingsma ◽  
Maxim J Mulder ◽  
Esmee Venema ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Acute Treatment ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Primary Outcome Measure

scholarly journals Baseline D-Dimer Levels as a Risk Assessment Biomarker for Recurrent Stroke in Patients with Combined Atrial Fibrillation and Atherosclerosis

2019 ◽  
Vol 8 (9) ◽  
pp. 1457 ◽  
Author(s):  
Kang-Ho Choi ◽  
Woo-Keun Seo ◽  
Man-Seok Park ◽  
Joon-Tae Kim ◽  
Jong-Won Chung ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Risk Assessment ◽  
Ischemic Stroke ◽  
Confidence Interval ◽  
Secondary Prevention ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Recurrent Stroke ◽  
Primary Outcome Measure ◽  
D Dimer

Background: We investigated the effect of D-dimer levels and efficacy of different antithrombotic therapies according to the baseline D-dimer levels on recurrent stroke in patients with atrial fibrillation (AF)-related stroke and atherosclerosis. Methods: We enrolled 1441 patients with AF-related stroke and atherosclerosis in this nationwide multicenter study. The primary outcome measure was the occurrence of recurrent ischemic stroke over a 3-year period. Results: High D-dimer levels (≥2 μg/mL) were significantly associated with higher risk of recurrent ischemic stroke (adjusted hazard ratio (HR), 1.80; 95% confidence interval (CI), 1.13–2.84; p = 0.012). The risk of recurrent stroke was similar between the anticoagulant and the antiplatelet groups in all subjects (adjusted HR, 0.78; 95% CI, 0.46–1.32; p = 0.369). However, in patients with high D-dimer levels (≥2 μg/mL), risk of recurrent stroke was significantly lower in the anticoagulant group than in the antiplatelet group (adjusted HR, 0.40; 95% CI, 0.18–0.87; p = 0.022). Conclusion: Our findings suggested that baseline D-dimer levels could be used as a risk assessment biomarker of recurrent stroke in patients with AF-related stroke and atherosclerosis. High D-dimer levels would facilitate the identification of patients who are more likely to benefit from anticoagulants to ensure secondary prevention of stroke.

scholarly journals Can diffusion- and perfusion-weighted imaging alone accurately triage anterior circulation acute ischemic stroke patients to endovascular therapy?

2018 ◽  
Vol 10 (12) ◽  
pp. 1132-1136 ◽  
Author(s):  
Dylan N Wolman ◽  
Michael Iv ◽  
Max Wintermark ◽  
Gregory Zaharchuk ◽  
Michael P Marks ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Primary Outcome Measure ◽  
Large Vessel Occlusion ◽  
Anterior Circulation ◽  
Vessel Occlusion ◽  
Endovascular Thrombectomy ◽  
Perfusion Weighted Imaging

Background and purposeAcute ischemic stroke (AIS) patients who benefit from endovascular treatment have a large vessel occlusion (LVO), small core infarction, and salvageable brain. We determined if diffusion-weighted imaging (DWI) and perfusion-weighted imaging (PWI) alone can correctly identify and localize anterior circulation LVO and accurately triage patients to endovascular thrombectomy (ET).Materials and methodsThis retrospective cohort study included patients undergoing MRI for the evaluation of AIS symptoms. DWI and PWI images alone were anonymized and scored for cerebral infarction, LVO presence and LVO location, DWI-PWI mismatch, and ET candidacy. Readers were blinded to clinical data. The primary outcome measure was accurate ET triage. Secondary outcomes were detection of LVO and LVO location.ResultsTwo hundred and nineteen patients were included. Seventy-three patients (33%) underwent endovascular AIS treatment. Readers correctly and concordantly triaged 70 of 73 patients (96%) to ET (κ=0.938; P=0.855) and correctly excluded 143 of 146 patients (98%; P=0.942). DWI and PWI alone had a 95.9% sensitivity and a 98.4% specificity for accurate endovascular triage. LVO were accurately localized to the ICA/M1 segment in 65 of 68 patients (96%; κ=0.922; P=0.817) and the M2 segment in 18 of 20 patients (90%; κ=0.830; P=0.529).ConclusionAIS patients with anterior circulation LVO are accurately identified using DWI and PWI alone, and LVO location may be correctly inferred from PWI. MRA omission may be considered to expedite AIS triage in hyperacute scenarios or may confidently supplant non-diagnostic or artifact-limited MRA.

scholarly journals Impact of Prior Statin Use on Reperfusion Rate and Stroke Outcomes in Patients Receiving Endovascular Treatment

2021 ◽  
Vol 10 (21) ◽  
pp. 5147
Author(s):  
Sang-Hwa Lee ◽  
Min Uk Jang ◽  
Yerim Kim ◽  
So Young Park ◽  
Chulho Kim ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Endovascular Treatment ◽  
Primary Outcome ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Dose Response Relationship ◽  
Stroke Outcomes ◽  
The Impact ◽  
Reperfusion Rate ◽  
Statin Use

Background: We evaluated the impact of prior statin use on successful reperfusion and stroke outcomes after endovascular treatment (EVT). Method: Using consecutive multicenter databases, we enrolled acute ischemic stroke patients receiving EVT between 2015 and 2021. Patients were classified into prior statin users and no prior statin users after a review of premorbid medications. The primary outcome measure was successful reperfusion defined as modified TICI grade 2b or 3 after EVT. Secondary outcome measures were early neurologic deterioration (END) and a 3-month modified Rankin Scale (mRS) score of 0 to 2. Results: Among 385 patients receiving EVT, 74 (19.2%) were prior statin users, who had a significantly higher successful reperfusion rate compared with no prior statin users (94.6% versus 78.8%, p = 0.002). Successful reperfusion and END occurrence were improved according to statin intensity with a dose–response relationship. In multivariate analysis, prior statin was associated with successful reperfusion after EVT (adjusted odds ratio (95% confidence interval) 5.31 (1.67–16.86)). In addition, prior statin was associated with a lower occurrence of END and good functional status. Conclusion: Our study showed that prior statin use before ischemic stroke might improve successful reperfusion and stroke outcomes after EVT.

scholarly journals Is Intra-Arterial Treatment for Acute Ischemic Stroke Less Effective in Women than in Men

2016 ◽  
Vol 5 (3-4) ◽  
pp. 174-178 ◽  
Author(s):  
Inger R. de Ridder ◽  
Puck S.S. Fransen ◽  
Debbie Beumer ◽  
Olvert A. Berkhemer ◽  
Lucie A. van den Berg ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Adverse Events ◽  
Acute Ischemic Stroke ◽  
Treatment Effect ◽  
Primary Outcome ◽  
Intervention Group ◽  
Control Group ◽  
Serious Adverse Events ◽  
Neuro Imaging ◽  
Mr Clean

Introduction: Stroke etiology and outcome after ischemic stroke differ between men and women. We examined if sex modifies the effect of intra-arterial treatment (IAT) in a randomized clinical trial of IAT for acute ischemic stroke in the Netherlands (MR CLEAN). Patients and Methods: The primary outcome was the score on the modified Rankin scale at 90 days. We tested for interaction between sex and treatment and estimated the treatment effect by sex with multiple ordinal logistic regression with adjustment for prognostic factors. Results: All 500 patients were included in the analysis; 292 (58.4%) were men. The treatment effect (adjusted common odds ratio) was 2.39 [95% confidence interval (CI) 1.55-3.68] in men and 0.99 (95% CI 0.60-1.66) in women (pinteraction = 0.016). In women, mortality was higher in the intervention group than in the control group (24 vs. 15%, p = 0.07). Serious adverse events occurred more often in women than in men undergoing intervention. There were no differences in neuro-imaging outcomes. Discussion and Conclusion: Contrary to other studies, we found a significant interaction between sex and treatment effect in the MR CLEAN trial. Pooled analyses of all published thrombectomy trials did not confirm this finding. In MR CLEAN, women seem to have a slightly more unfavorable profile, causing higher mortality and more serious adverse events, but insufficient to explain the absence of an overall effect. This suggests a play of chance and makes it clear that IAT should not be withheld in women.

Predictors of poor outcome despite successful endovascular treatment for ischemic stroke: results from the MR CLEAN Registry

2021 ◽  
pp. neurintsurg-2021-017726
Author(s):  
Rob A van de Graaf ◽  
Noor Samuels ◽  
Vicky Chalos ◽  
Geert J Lycklama a Nijeholt ◽  
Heleen van Beusekom ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Adverse Events ◽  
Endovascular Treatment ◽  
Functional Outcome ◽  
Functional Independence ◽  
National Institutes Of Health ◽  
Patient Factors ◽  
Poor Functional Outcome ◽  
Symptomatic Intracranial Hemorrhage ◽  
Mr Clean

BackgroundApproximately one-third of patients with ischemic stroke treated with endovascular treatment do not recover to functional independence despite rapid and successful recanalization. We aimed to quantify the importance of predictors of poor functional outcome despite successful reperfusion.MethodsWe analyzed patients from the MR CLEAN Registry between March 2014 and November 2017 with successful reperfusion (extended Thrombolysis In Cerebral Infarction ≥2B). First, predictors were selected based on expert opinion and were clustered according to acquisition over time (ie, baseline patient factors, imaging factors, treatment factors, and postprocedural factors). Second, several models were constructed to predict 90-day functional outcome (modified Rankin Scale (mRS)). The relative importance of individual predictors in the most extensive model was expressed by the proportion of unique added χ2 to the model of that individual predictor.ResultsOf 3180 patients, 1913 (60%) had successful reperfusion. Of these 1913 patients, 1046 (55%) were functionally dependent at 90 days (mRS >2). The most important predictors for mRS were baseline patient factors (ie, pre-stroke mRS, added χ2 0.16; National Institutes of Health Stroke Scale score at baseline, added χ2 0.12; age, added χ2 0.10), and postprocedural factors (ie, symptomatic intracranial hemorrhage (sICH), added χ2 0.12; pneumonia, added χ2 0.09). The probability of functional independence for a typical stroke patient with sICH was 54% (95% CI 36% to 72%) lower compared with no sICH, and 21% (95% CI 4% to 38%) for pneumonia compared with no pneumonia.ConclusionBaseline patient factors and postprocedural adverse events are important predictors of poor functional outcome in successfully reperfused patients with ischemic stroke. This implies that prevention of postprocedural adverse events has the greatest potential to further improve outcomes in these patients.

Endovascular reperfusion of M2 occlusions in acute ischemic stroke reduced disability and mortality: ETIS Registry results

2021 ◽  
pp. neurintsurg-2021-017380
Author(s):  
Patricio Muszynski ◽  
Mohammad Anadani ◽  
Sébastien Richard ◽  
Gaultier Marnat ◽  
Romain Bourcier ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Endovascular Treatment ◽  
Acute Ischemic Stroke ◽  
Primary Outcome ◽  
Intravenous Thrombolysis ◽  
National Institutes Of Health ◽  
Favorable Outcome ◽  
Nihss Score ◽  
Excellent Outcome ◽  
Procedural Complications

BackgroundThe predictors of successful reperfusion and the effect of reperfusion after endovascular treatment (EVT) for M2 occlusions have not been well studied. We aimed to identify predictors of successful reperfusion and the effect of reperfusion on outcomes of EVT for M2 occlusions in current practice.MethodsPatients with acute ischemic stroke due to isolated M2 occlusions who were enrolled in the prospective multicenter Endovascular Treatment in Ischemic Stroke (ETIS) Registry in France between January 2015 and March 2020 were included. The primary outcome was a favorable outcome, defined as modified Rankin Scale (mRS) score of 0–2 at 90 days. Successful reperfusion was defined as an improvement of ≥1 points in the modified Thrombolysis In Cerebral Infarction score between the first and the last intracranial angiogram.ResultsA total of 458 patients were included (median National Institutes of Health Stroke Scale (NIHSS) score 14; 61.4% received prior intravenous thrombolysis). Compared with the non-reperfused patients, reperfused patients had an increased rate of excellent outcome (OR 2.3, 95% CI 0.98 to 5.36; p=0.053), favorable outcome (OR 2.79, 95% CI 1.31 to 5.93; p=0.007), and reduced 90-day mortality (OR 0.39, 95% CI 0.19 to 0.79; p<0.01). Admission NIHSS score was the only predictor of successful reperfusion. First-line strategy was not a predictor of successful reperfusion or favorable outcome, but the use of a stent retriever, alone or with an aspiration catheter, was associated with higher rates of procedural complications and 90-day mortality.ConclusionsSuccessful reperfusion of M2 occlusions reduced disability and mortality. However, safety is a concern, especially if the procedure failed.

scholarly journals Clinical impact of left and right axis deviations with narrow QRS complex on 3-year outcomes in a hospital-based population in Japan

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Yuta Seko ◽  
Takao Kato ◽  
Yuhei Yamaji ◽  
Yoshisumi Haruna ◽  
Eisaku Nakane ◽  
...  
Keyword(s):  
Cardiovascular Events ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Conduction Block ◽  
Primary Outcome Measure ◽  
Excess Risk ◽  
Major Adverse Cardiovascular Events ◽  
Prognostic Impact ◽  
Axis Deviation ◽  
The Right

AbstractWhile the prognostic impact of QRS axis deviation has been assessed, it has never been investigated in patients without conduction block. Thus, we evaluated the prognostic impact of QRS-axis deviation in patients without conduction block. We retrospectively analyzed 3353 patients who had undergone both scheduled transthoracic echocardiography and electrocardiography in 2013 in a hospital-based population, after excluding patients with a QRS duration of ≥ 110 ms, pacemaker placement, and an QRS-axis − 90° to − 180° (northwest axis). The study population was categorized into three groups depending on the mean frontal plane QRS axis as follows: patients with left axis deviation (N = 171), those with right axis deviation (N = 94), and those with normal axis (N = 3088). The primary outcome was a composite of all-cause death and major adverse cardiovascular events. The cumulative 3-year incidence of the primary outcome measure was significantly higher in the left axis deviation group (26.4% in the left axis deviation, 22.7% in the right axis deviation, and 18.4% in the normal axis groups, log-rank P = 0.004). After adjusting for confounders, the excess risk of primary outcome measure remained significant in the left axis deviation group (hazard ratio [HR] 1.44; 95% confidence interval [CI] 1.07–1.95; P = 0.02), while the excess risk of primary outcome measure was not significant in the right axis deviation group (HR 1.22; 95% CI 0.76–1.96; P = 0.41). Left axis deviation was associated with a higher risk of a composite of all-cause death and major adverse cardiovascular events in hospital-based patients without conduction block in Japan.

scholarly journals Computerised cognitive–behavioural therapy for adults with intellectual disability: randomised controlled trial

2017 ◽  
Vol 211 (2) ◽  
pp. 95-102 ◽  
Author(s):  
Patricia Cooney ◽  
Catherine Jackman ◽  
David Coyle ◽  
Gary O'Reilly
Keyword(s):  
Intellectual Disability ◽  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Controlled Trial ◽  
Behavioural Therapy ◽  
Primary Outcome Measure ◽  
Cognitive Behavioural ◽  
Randomised Controlled

BackgroundDespite the evidence base for computer-assisted cognitive–behavioural therapy (CBT) in the general population, it has not yet been adapted for use with adults who have an intellectual disability.AimsTo evaluate the utility of a CBT computer game for adults who have an intellectual disability.MethodA 2 × 3 (group × time) randomised controlled trial design was used. Fifty-two adults with mild to moderate intellectual disability and anxiety or depression were randomly allocated to two groups: computerised CBT (cCBT) or psychiatric treatment as usual (TAU), and assessed at pre-treatment, post-treatment and 3-month follow-up. Forty-nine participants were included in the final analysis.ResultsA significant group x time interaction was observed on the primary outcome measure of anxiety (Glasgow Anxiety Scale for people with an Intellectual Disability), favouring cCBT over TAU, but not on the primary outcome measure of depression (Glasgow Depression Scale for people with a Learning Disability). A medium effect size for anxiety symptoms was observed at post-treatment and a large effect size was observed after follow-up. Reliability of Change Indices indicated that the intervention produced clinically significant change in the cCBT group in comparison with TAU.ConclusionsAs the first application of cCBT for adults with intellectual disability, this intervention appears to be a useful treatment option to reduce anxiety symptoms in this population.

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