scholarly journals Ensuring reliability of outcome measures in multicenter clinical trials of treatments for acute ischemic stroke. The program developed for the Trial of Org 10172 in Acute Stroke Treatment (TOAST).

Stroke ◽  
1994 ◽  
Vol 25 (9) ◽  
pp. 1746-1751 ◽  
Author(s):  
M A Albanese ◽  
W R Clarke ◽  
H P Adams ◽  
R F Woolson
Stroke ◽  
2021 ◽  
Vol 52 (Suppl_1) ◽  
Author(s):  
RAJAN R GADHIA ◽  
Farhaan S Vahidy ◽  
Tariq Nisar ◽  
Destiny Hooper ◽  
David Chiu ◽  
...  

Objective: Most acute stroke treatment trials exclude patients above the age of 80. Given the clear benefit of revascularization with intravenous tissue plasminogen activator (IV tPA) and mechanical thrombectomy (MT), we sought to assess functional outcomes in patients treated above the age of 80. Methods: We conducted a review of all patients admitted to Houston Methodist Hospital between January 2019 and August 2020 with an acute ischemic stroke (AIS) presentation[MOU1] for whom premorbid, discharge, and 90 day modified Rankin Scale scores were available. Patients were categorized by acute stroke treatment (IV tPA, MT, both or none[MOU2] ). mRS values were assessed during admission prior to discharge and at 90 days post stroke event. A delta mRS (Discharge vs. 90-day [MOU3] ) was defined and grouped as no change, improved, or worsened to assess overall functional disability in regards to the index stroke presentation. Results: A total of 865 patients with AIS presentation were included, of whom 651 (75.3%) were <80 years and 214 (24.7%) were > 80 years of age at presentation. A total of 208 patients received IV tPA, 176 underwent revascularization with MT only, 71 had both treatments, and 552 had no acute intervention. In patients >80 yrs who had no acute stroke intervention. mRS improvement was noted in 71.4% compared to 54.1% observed in those patients <80 years. Among patients who received IV tPA, 81.5% of > 80 years improved vs. 61.6% in the younger cohort. A similar trend was noted in the MT and combined treatment groups (76.2% vs. 71.2% and 78.6% vs. 79.3%, respectively). Conclusion: Based on our cohort of acute stroke patients, there was no significant difference in outcomes (as measured by delta mRS) for octogenarians and nonagenarians when compared to younger patients. There was a trend towards improvement in the elderly patients. Chronological age by itself may be an insufficient predictor of functional outcome among stroke patients and age cutoffs for enrollment of patients in acute stroke trials may need additional considerations.


2021 ◽  
Vol 10 (16) ◽  
pp. 3677
Author(s):  
Rajeel Imran ◽  
Ghada A Mohamed ◽  
Fadi Nahab

The field of acute stroke treatment has made tremendous progress in reducing the overall burden of disability. Understanding the pathophysiology of acute ischemic injury, neuroimaging to quantify the extent of penumbra and infarction, and acute stroke reperfusion therapies have together contributed to these advancements. In this review we highlight advancements in reperfusion therapies for acute ischemic stroke.


2017 ◽  
Vol 75 (12) ◽  
pp. 881-889 ◽  
Author(s):  
Leslie Ecker Ferreira ◽  
Paulo Henrique Condeixa de França ◽  
Vivian Nagel ◽  
Vanessa Venancio ◽  
Juliana Safanelli ◽  
...  

ABSTRACT Aiming to contribute to studies that use detailed clinical and genomic information of biobanks, we present the initial results of the first Latin American Stroke Biobank. Methods: Blood samples were collected from patients included in the Joinville Stroke Registry and four Brazilian cities. Demographic socio-economic data, cardiovascular risk factors, Causative Classification System for Ischemic Stroke, Trial of Org 10172 in Acute Stroke Treatment and National Institutes of Health scores, functional stroke status (modified Rankin) and brain images were recorded. Additionally, controls from both geographic regions were recruited. High-molecular-weight genomic DNA was obtained from all participants. Results: A total of 2,688 patients and 3,282 controls were included. Among the patients, 76% had ischemic stroke, 12% transient ischemic attacks, 9% hemorrhagic stroke and 3% subarachnoid hemorrhage. Patients with undetermined ischemic stroke were most common according the Trial of Org 10172 in Acute Stroke Treatment (40%) and Causative Classification System for Ischemic Stroke (47%) criteria. A quarter of the patients were under 55 years of age at the first-ever episode. Conclusions: We established the Joinville Stroke Biobank and discuss its potential for contributing to the understanding of the risk factors leading to stroke.


2018 ◽  
Vol 265 (8) ◽  
pp. 1871-1879 ◽  
Author(s):  
Konark Malhotra ◽  
Jason J. Chang ◽  
Arjun Khunger ◽  
David Blacker ◽  
Jeffrey A. Switzer ◽  
...  

Stroke ◽  
2014 ◽  
Vol 45 (suppl_1) ◽  
Author(s):  
Hari Kishan R Indupuru ◽  
Loren Shen ◽  
Amber N Jacobs ◽  
Chunyan Cai ◽  
James C Grotta ◽  
...  

Background and objectives: Enrollment into AIS trials has always been limited by the ability of the patient to give informed consent or the availability of a Legally Authorized Representative (LAR) in decision making capacity on behalf of the patient. In this analysis we try to identify the factors contributing to an acute ischemic stroke (AIS) patient’s inability to give informed consent. We hypothesized that clinical features and demographics would differ between those patients with and without capacity to consent. Methods: This analysis includes patients who enrolled into the coordinating center of the prospective, randomized ARTSS-2 clinical trial (Argatroban + TPA for acute ischemic stroke) and also screen failures due to inability to consent. Data is collected prospectively in the study screening log. The data collected included age, gender, race, NIHSS, lesion location, ER arrival time and mode of consent (self-consent, LAR-consent and unable to consent). Results: Between 12/11 and 06/13, a total of 33 acute ischemic stroke patients received IV-tPA and were eligible for the ARTSS-2 study. While 19 were enrolled, 14/33 (42.4%) were otherwise eligible, but not enrolled due to inability to self-consent and no LAR present. Patients not enrolled due to lack of capacity to consent and without LAR present tended to have higher median NIHSS scores and greater proportions of drowsiness and aphasia compared to the other groups (see table). Conclusion: Approximately 2 in 5 AIS patients are not eligible for AIS clinical trials based solely on their lack of capacity for informed consent. It is remains ethically imperative that current clinical trials as well as future study designs address this disregarded group of patients who deserve the right to be able to participate in research. Addressing this group of patients through exception from informed consent (EFIC) will both extend research to all stroke patients, but also greatly enhance AIS research.


Stroke ◽  
2021 ◽  
Vol 52 (Suppl_1) ◽  
Author(s):  
Xin Tong ◽  
Sallyann Coleman King ◽  
Erika Odom ◽  
Quanhe Yang

Introduction: Studies suggest a significant reduction in emergency department visits and hospitalizations for acute ischemic stroke (AIS) during the COVID-19 pandemic in the United States. Few studies have examined AIS hospitalizations, treatments, and outcomes during the pandemic period. The present study compared the demographic and clinical characteristics of patients hospitalized with AIS before and during the COVID-19 pandemic (weeks 11-24 in 2019 vs. 2020). Method: We identified 42,371 admissions with a clinical diagnosis of AIS, from 370 participating hospitals who contributed data during weeks 11-24 in both 2019 and 2020 to the Paul Coverdell National Acute Stroke Program (PCNASP). Results: During weeks 11-24 of the COVID-19 period, AIS hospitalizations declined by 24.5% compared to the same period in 2019 (18,233 in 2020 vs. 24,138 in 2019). In 2020, the percentage of individuals aged <65 years who were hospitalized with AIS was higher compared with the same period in 2019 (34.6% vs. 32.7%, p<0.001); arriving by EMS were higher in 2020 compared with 2019 (47.7% vs. 44.8%, p<0.001). Individuals admitted with AIS in 2020 had a higher mean National Institutes of Health Stroke Scale (NIHSS) score compared with 2019 (6.7 vs. 6.3, p<0.001). In 2020, the in-hospital death rates increased by 16% compared to 2019 (5.0% vs. 4.3%, p<0.001). However, there were no differences in rates of alteplase use, achievement of door to needle in 60 minutes, or complications from reperfusion therapy between the two time periods. Conclusion: A higher percentage of younger (<65 years) individuals and more severe AIS cases were admitted to the participating hospitals during weeks 11 to 24 of the COVID-19 pandemic in 2020 compared to the same period in 2019. The AIS in-hospital death rate increased 16% during the pandemic weeks as compared to the same weeks in 2019. Additional studies are needed to examine the impacts of the COVID-19 pandemic on stroke treatment and outcomes.


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