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Stroke 02/2013; · 5.73 Impact Factor
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Edward C Jauch,
Jeffrey L Saver, Harold P Adams,
Askiel Bruno,
J J Buddy Connors,
Bart M Demaerschalk,
Pooja Khatri,
Paul W McMullan,
Adnan I Qureshi,
Kenneth Rosenfield,
Phillip A Scott,
Debbie R Summers,
David Z Wang,
Max Wintermark,
Howard Yonas
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ABSTRACT: BACKGROUND AND PURPOSE: The authors present an overview of the current evidence and management recommendations for evaluation and treatment of adults with acute ischemic stroke. The intended audiences are prehospital care providers, physicians, allied health professionals, and hospital administrators responsible for the care of acute ischemic stroke patients within the first 48 hours from stroke onset. These guidelines supersede the prior 2007 guidelines and 2009 updates. METHODS: Members of the writing committee were appointed by the American Stroke Association Stroke Council's Scientific Statement Oversight Committee, representing various areas of medical expertise. Strict adherence to the American Heart Association conflict of interest policy was maintained throughout the consensus process. Panel members were assigned topics relevant to their areas of expertise, reviewed the stroke literature with emphasis on publications since the prior guidelines, and drafted recommendations in accordance with the American Heart Association Stroke Council's Level of Evidence grading algorithm. RESULTS: The goal of these guidelines is to limit the morbidity and mortality associated with stroke. The guidelines support the overarching concept of stroke systems of care and detail aspects of stroke care from patient recognition; emergency medical services activation, transport, and triage; through the initial hours in the emergency department and stroke unit. The guideline discusses early stroke evaluation and general medical care, as well as ischemic stroke, specific interventions such as reperfusion strategies, and general physiological optimization for cerebral resuscitation. CONCLUSIONS: Because many of the recommendations are based on limited data, additional research on treatment of acute ischemic stroke remains urgently needed.
Stroke 01/2013; · 5.73 Impact Factor
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ABSTRACT: Object The Carotid Occlusion Surgery Study (COSS) was conducted to determine if superficial temporal artery-middle cerebral artery (STA-MCA) bypass, when added to the best medical therapy, would reduce subsequent ipsilateral stroke in patients with complete internal carotid artery (ICA) occlusion and an elevated oxygen extraction fraction (OEF) in the cerebral hemisphere distal to the occlusion. A recent publication documented the methodology of the COSS in detail and briefly outlined the major findings of the trial. The surgical results of the COSS are described in detail in this report. Methods The COSS was a prospective, parallel-group, 1:1 randomized, open-label, blinded-adjudication treatment trial. Participants, who had angiographically demonstrated complete occlusion of the ICA causing either a transient ischemic attack or ischemic stroke within 120 days and hemodynamic cerebral ischemia indicated by an increased OEF measured by PET, were randomized to either surgical or medical treatment. One hundred ninety-five patients were randomized: 97 to the surgical group and 98 to the medical group. The surgical patients underwent an STA-MCA cortical branch anastomosis. Results In the intention-to-treat analysis, the 2-year rates for the primary end point were 21% for the surgical group and 22.7% for the medical group (p = 0.78, log-rank test). Fourteen (15%) of the 93 patients who had undergone an arterial bypass had a primary end point ipsilateral hemispheric stroke in the 30-day postoperative period, 12 within 2 days after surgery. The STA-MCA arterial bypass patency rate was 98% at the 30-day postoperative visit and 96% at the last follow-up examination. The STA-MCA arterial bypass markedly improved, although it did not normalize, the level of elevated OEF in the symptomatic cerebral hemisphere. Five surgically treated and 1 nonsurgically treated patients in the surgical group had a primary end point ipsilateral hemispheric stroke after the 30-day postoperative period. No baseline characteristics or intraoperative variables revealed those who would experience a procedure-related stroke. Conclusions Despite excellent bypass graft patency and improved cerebral hemodynamics, STA-MCA anastomosis did not provide an overall benefit regarding ipsilateral 2-year stroke recurrence, mainly because of a much better than expected stroke recurrence rate (22.7%) in the medical group, but also because of a significant postoperative stroke rate (15%). Clinical trial registration no.: NCT00029146.
Journal of Neurosurgery 10/2012; · 2.96 Impact Factor
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Neurosurgery 09/2012; 71(3):E772-6. · 2.79 Impact Factor
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Stroke 08/2012; 43(10):2829-32. · 5.73 Impact Factor
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ABSTRACT: There is controversy regarding the threshold for treating patients with mild strokes. Physicians often withhold acute treatment in these patients if they perceive the symptoms are not going to be disabling. We tested the appropriateness of this practice by analyzing the relationship between specific neurological deficits in the National Institutes of Health Stroke Scale (NIHSS) score and long-term outcome among patients with a low total NIHSS score.
We performed a secondary analysis on those patients enrolled in the Trial of ORG 10172 in Acute Stroke Treatment that presented within 4.5 hours of symptom onset and had a baseline NIHSS score ≤6 (n=194). We performed multivariate logistic regression analyses using very favorable outcome at 3 months as the outcome variable and each of the individual items of the baseline NIHSS examination and syndromic combinations of NIHSS scores as predictors. The analyses were adjusted for potential confounders with and without adjusting for total NIHSS score.
Baseline total NIHSS scores were inversely associated with very favorable outcome at 3 months. No individual NIHSS item, or syndromic combination of NIHSS scores, was independently associated with very favorable outcome in a consistent manner after accounting for confounders and collinearity.
The types of neurological deficits in the baseline NIHSS are not independent predictors of long-term prognosis for patients with mild stroke. These exploratory findings argue against the practice of withholding reperfusion treatment in patients with mild stroke when the types of baseline NIHSS deficits are perceived to be nondisabling.
Stroke 03/2012; 43(3):782-6. · 5.73 Impact Factor
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ABSTRACT: Patients with symptomatic atherosclerotic internal carotid artery occlusion (AICAO) and hemodynamic cerebral ischemia are at high risk for subsequent stroke when treated medically.
To test the hypothesis that extracranial-intracranial (EC-IC) bypass surgery, added to best medical therapy, reduces subsequent ipsilateral ischemic stroke in patients with recently symptomatic AICAO and hemodynamic cerebral ischemia.
Parallel-group, randomized, open-label, blinded-adjudication clinical treatment trial conducted from 2002 to 2010.
Forty-nine clinical centers and 18 positron emission tomography (PET) centers in the United States and Canada. The majority were academic medical centers.
Patients with arteriographically confirmed AICAO causing hemispheric symptoms within 120 days and hemodynamic cerebral ischemia identified by ipsilateral increased oxygen extraction fraction measured by PET. Of 195 patients who were randomized, 97 were randomized to receive surgery and 98 to no surgery. Follow-up for the primary end point until occurrence, 2 years, or termination of trial was 99% complete. No participant withdrew because of adverse events.
Anastomosis of superficial temporal artery branch to a middle cerebral artery cortical branch for the surgical group. Antithrombotic therapy and risk factor intervention were recommended for all participants.
For all participants who were assigned to surgery and received surgery, the combination of (1) all stroke and death from surgery through 30 days after surgery and (2) ipsilateral ischemic stroke within 2 years of randomization. For the nonsurgical group and participants assigned to surgery who did not receive surgery, the combination of (1) all stroke and death from randomization to randomization plus 30 days and (2) ipsilateral ischemic stroke within 2 years of randomization.
The trial was terminated early for futility. Two-year rates for the primary end point were 21.0% (95% CI, 12.8% to 29.2%; 20 events) for the surgical group and 22.7% (95% CI, 13.9% to 31.6%; 20 events) for the nonsurgical group (P = .78, Z test), a difference of 1.7% (95% CI, -10.4% to 13.8%). Thirty-day rates for ipsilateral ischemic stroke were 14.4% (14/97) in the surgical group and 2.0% (2/98) in the nonsurgical group, a difference of 12.4% (95% CI, 4.9% to 19.9%).
Among participants with recently symptomatic AICAO and hemodynamic cerebral ischemia, EC-IC bypass surgery plus medical therapy compared with medical therapy alone did not reduce the risk of recurrent ipsilateral ischemic stroke at 2 years.
clinicaltrials.gov Identifier: NCT00029146.
JAMA The Journal of the American Medical Association 11/2011; 306(18):1983-92. · 30.03 Impact Factor
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The Lancet Neurology 02/2011; 10(2):110-1. · 23.46 Impact Factor
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ABSTRACT: Microhemorrhages on gradient-echo T2*-weighted MRI sequences are often found in patients with cerebrovascular disease and are related to intracerebral hemorrhage. Because statin therapy is associated with increased risk of intracerebral hemorrhage, we investigated whether statin use was also associated with microhemorrhages in patients with acute ischemic stroke or transient ischemic attack.
We performed a retrospective analysis on prospectively collected data from a stroke registry containing patients with acute ischemic stroke or transient ischemic attack. The primary and secondary outcome variables were the prevalence and degree of microhemorrhages as detected on gradient-echo MRI sequences and categorized as mild (1-2), moderate (3-10), or severe (>10). The location of the microhemorrhages was noted and rated by 2 neuroradiologists. Previous use of statins and other covariates were assessed as potential predictors.
Three hundred forty-nine patients were admitted from June 2008 to July 2009, and 300 of which were analyzed. Microhemorrhages were detected in 70 subjects (23%); 35 had only lobar lesions, 16 had only deep lesions, and 19 had both lobar and deep lesions. On univariate and multivariate analysis, statin therapy was not associated with the prevalence (OR, 0.73; 95% CI, 0.36-1.51; P=0.40) or degree of microhemorrhages modeled for lesser severity (OR, 2.31; 95% CI, 0.61-8.75; P=0.22).
Previous statin therapy was not associated with the prevalence or degree of microhemorrhages in patients with acute ischemic stroke or transient ischemic attack. The association between statins and intracerebral hemorrhage does not appear to be mediated through microhemorrhages.
Stroke 02/2011; 42(2):354-8. · 5.73 Impact Factor
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ABSTRACT: Stroke often produces marked physical and cognitive impairments leading to functional dependence, caregiver burden, and poor quality of life. We examined the course of disability during a 1-year follow-up period after stroke among patients who were administered antidepressants for 3 months compared to patients given placebo for 3 months.
A total of 83 patients entered a double-blind randomized study of the efficacy of antidepressants to treat depressive disorders and reduce disability after stroke. Patients were assigned to either fluoxetine (N = 32), nortriptyline (N = 22) or placebo (N = 29). Psychiatric assessment included administration of the Present State Examination modified to identify DSM-IV symptoms of depression. The severity of depression was measured using the 17-item Hamilton Depression Rating Scale. The modified Rankin Scale was used to evaluate the disability of patients at initial evaluation and at quarterly follow-up visits for 1 year. Impairment in activities of daily living was assessed by Functional Independence Measure at the same time.
During the 1-year follow-up period, and after adjusting for critical confounders including age, intensity of rehabilitation therapy, baseline stroke severity, and baseline Hamilton Depression Rating Scale, patients who received fluoxetine or nortriptyline had significantly greater improvement in modified Rankin Scale scores compared to patients who received placebo (t [156] = -3.17, p = 0.002).
Patients treated with antidepressants had better recovery from disability by 1-year post stroke (i.e., 9 months after antidepressants were stopped) than patients who did not receive antidepressant therapy. This effect was independent of depression suggesting that antidepressants may facilitate the neural mechanisms of recovery in patients with stroke.
The American journal of geriatric psychiatry: official journal of the American Association for Geriatric Psychiatry 02/2011; 19(12):1007-15. · 3.35 Impact Factor
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Harold P Adams
Current Neurology and Neuroscience Reports 10/2010; 11(1):1-5. · 3.45 Impact Factor
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ABSTRACT: Hemorrhagic transformation (HT) is a feared complication of reperfusion therapy for treatment of acute ischemic stroke. Generally, HT occurs within 24-36 hours after thrombolysis.
We present a case of a fatal symptomatic HT of an infarction that occurred 7 days after acute ischemic stroke which was preceded by a remarkable recovery following a combination of acute revascularization therapies.
Fatal symptomatic HT is a rare potential complication that can occur after several days of treatment of acute ischemic stroke.
Journal of stroke and cerebrovascular diseases: the official journal of National Stroke Association 10/2010; 21(2):151-4.
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Harold P Adams
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ABSTRACT: Stroke is a life-threatening or life-changing disease that is expensive in health care costs and lost productivity. Stroke also is a leading cause of human suffering. While the risk of stroke may be reduced with advances in prevention, recent advances in acute care can limit the consequences of stroke. In particular, the success of reperfusion therapies including intra-arterial interventions and intravenous administration of thrombolytic agents means that some patients with stroke may be cured. Still, the time window for effective treatment of stroke is relatively short. As a result, modern stroke management requires the close collaboration of the public, health care providers, administrators, insurance companies, and the government. Potential strategies to extend modern stroke care to as many patients as possible include 1) educational programs to train community emergency medical service personnel and physicians, 2) development of stroke care plans at community hospitals, 3) an integrated community-comprehensive stroke center program based on consultation, and telemedicine. The goal is to have a highly integrated approach to provide emergency treatment of the stroke that provides key emergency treatment, including intravenous administration of thrombolytic medications, at a community hospital (primary stroke center) with evacuation to a comprehensive stroke center that has resources and expertise that are not available in the primary stroke center. Taiwan is an ideal location for the development of such regional stroke programs.
Acta neurologica Taiwanica 09/2010; 19(3):153-63.
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ABSTRACT: Acute stroke trials are becoming increasingly multinational. Working toward a shared ethical standard for acute stroke research necessitates evaluating the degree of consensus among international researchers. We surveyed all 275 coinvestigators and coordinators who participated in the AbESTT II study (evaluating abciximab vs placebo) about their experience with their local institutional review board (IRB) or equivalent, as well as, about their personal beliefs regarding the ethical aspects of acute stroke trials. A total of 90 coinvestigators from 15 different countries responded to our survey. Among the IRBs represented by the responding coinvestigators, only 18% allowed surrogate consent to be obtained over the phone. Although 52% allowed the participation of subjects with aphasia, only 5% allowed the participation of subjects with neglect/hemi-inattention. The National Institutes of Health Stroke Scale score was deemed adequate to establish decisional capacity based on language by 62% of the coinvestigators and 36% of the IRBs. A belief that IRB regulations cause unnecessary delays and fear in relatives/patients was reported by 67% of coinvestigators, and the belief that granting an exemption from informed consent under specific circumstances is appropriate was reported by 41%. There appears to be considerable international diversity in the ethical priorities and informed consent standards among different IRBs and investigators in stroke research. The stroke community should make an attempt to standardize the consent process used in research. Given the critical nature of the time to treatment in stroke care, these standards should be integrated into current frameworks of clinical care and research. The absence of an ethical consensus can become a barrier to advancing stroke treatment internationally.
Journal of stroke and cerebrovascular diseases: the official journal of National Stroke Association 08/2010; 21(3):200-4.
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Harold P Adams
The Lancet Neurology 02/2010; 9(2):131-3. · 23.46 Impact Factor
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Harold P Adams
Circulation 02/2010; 121(7):846-7. · 14.74 Impact Factor
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ABSTRACT: Adjunctive restorative therapies administered during the first few months after stroke, the period with the greatest degree of spontaneous recovery, reduce the number of stroke patients with significant disability.
To examine the effect of escitalopram on cognitive outcome. We hypothesized that patients who received escitalopram would show improved performance in neuropsychological tests assessing memory and executive functions than patients who received placebo or underwent Problem Solving Therapy.
Randomized trial.
Stroke center.
One hundred twenty-nine patients were treated within 3 months following stroke. The 12-month trial included 3 arms: a double-blind placebo-controlled comparison of escitalopram (n = 43) with placebo (n = 45), and a nonblinded arm of Problem Solving Therapy (n = 41).
Change in scores from baseline to the end of treatment for the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) and Trail-Making, Controlled Oral Word Association, Wechsler Adult Intelligence Scale-III Similarities, and Stroop tests.
We found a difference among the 3 treatment groups in change in RBANS total score (P < .01) and RBANS delayed memory score (P < .01). After adjusting for possible confounders, there was a significant effect of escitalopram treatment on the change in RBANS total score (P < .01, adjusted mean change in score: escitalopram group, 10.0; nonescitalopram group, 3.1) and the change in RBANS delayed memory score (P < .01, adjusted mean change in score: escitalopram group, 11.3; nonescitalopram group, 2.5). We did not observe treatment effects in other neuropsychological measures.
When compared with patients who received placebo or underwent Problem Solving Therapy, stroke patients who received escitalopram showed improvement in global cognitive functioning, specifically in verbal and visual memory functions. This beneficial effect of escitalopram was independent of its effect on depression. The utility of antidepressants in the process of poststroke recovery should be further investigated. Trial Registration clinicaltrials.gov Identifier: NCT00071643.
Archives of general psychiatry 02/2010; 67(2):187-96. · 12.26 Impact Factor
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Harold P Adams
Current Neurology and Neuroscience Reports 01/2010; 10(1):4-6. · 3.45 Impact Factor
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Stroke 06/2009; 40(8):2945-8. · 5.73 Impact Factor
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ABSTRACT: Methods to increase recruitment into acute stroke trials are needed. The purposes of this study were to evaluate the safety and acceptability of initiating acute stroke trials during early helicopter evacuation and to test an intervention to facilitate informed consent.
A randomized, controlled trial was done with patients with acute stroke who were transferred by helicopter to the University of Iowa Hospitals and Clinics from February 2007 to January 2008. The intervention to be evaluated was the use of fax and a telephone call to the patient/surrogate ahead of helicopter arrival at the outside emergency department. The aim was to improve the rate of subsequent consent (primary outcome) for a pilot trial of a potentially beneficial, low-risk medical intervention (ranitidine) to prevent aspiration pneumonitis. Consenting eligible patients received the infusion during the flight to University of Iowa Hospitals and Clinics.
One hundred patients were enrolled. Consent rate was 54% in the intervention group and 50% in the control group (P=0.69). However, the consent rate was higher (69%) when prearrival communications between the coinvestigator and potential subjects were successful (P=0.04). This approach resulted in an average gain of 59 minutes as compared with initiating recruitment on arrival to University of Iowa Hospitals and Clinics.
Enrollment into stroke intervention trials is feasible during helicopter transportation from a community hospital emergency department to a tertiary stroke center. This underused resource may improve trial efficiency by enabling and expediting participation of remote populations currently excluded from research. Consent rates might be further improved by communication strategies that are more successful in reaching patients at outside emergency departments.
Stroke 02/2009; 40(3):895-901. · 5.73 Impact Factor
