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1.  The Cog-4 Subset of the National Institutes of Health Stroke Scale as a Measure of Cognition: Relationship with Baseline Factors and Functional Outcome after Stroke Using Data from the Virtual International Stroke Trials Archive 
Stroke Research and Treatment  2013;2013:562506.
Background. Assessing poststroke cognitive impairment is complex. A subscale of the NIHSS, the Cog-4, has been proposed as a quick test of “cognitive impairment.” but a study of its properties in a larger dataset is lacking. Methods. Data from 9,147 patients with acute stroke from the VISTA archive was used to generate Cog-4 scores. The statistical properties of Cog-4, its relationship with baseline clinical characteristics, and other functional outcome measures at day 90 were assessed. Results. Mean age of patients was 69.2 years and 45.8%, were females. Day-90 Cog-4 was highly positively skewed (skewness 0.926). Patients with left hemispheric stroke had higher day-90 Cog-4 score (P < 0.001). Age, stroke severity, and previous stroke were significant predictors of Cog-4. Cog-4 was significantly correlated with dependency (modified Rankin Scale, rs = 0.512), and disability (Barthel Index, rs = −0.493). Conclusions. The Cog-4 scale at day 90 cannot be considered a useful test of cognition since it only superficially measures cognition. It is heavily dependent on the side of stroke, is inevitably associated with functional outcome (being a subset of the NIHSS), and suffers from a profound “floor” effect. Specific and validated measures are more appropriate for the assessment of poststroke cognition than Cog-4.
doi:10.1155/2013/562506
PMCID: PMC3622404  PMID: 23589782
2.  Determining the Feasibility of Ambulance-Based Randomised Controlled Trials in Patients with Ultra-Acute Stroke: Study Protocol for the “Rapid Intervention with GTN in Hypertensive Stroke Trial” (RIGHT, ISRCTN66434824) 
Stroke Research and Treatment  2012;2012:385753.
Background. Time from acute stroke to enrolment in clinical trials needs to be reduced to improve the chances of finding effective treatments. No completed randomised controlled trials of ambulance-based treatment for acute stroke have been reported in the UK, and the practicalities of recruiting, consenting, and treating patients are unknown. Methods. RIGHT is an ambulance based, single-blind, randomised controlled trial with blinded-outcome assessment. The trial will assess feasibility of using ambulance services to deliver ultra-acute stroke treatments; a secondary aim is to assess the effect of glyceryl trinitrate (GTN) on haemodynamic variables and functional outcomes. Initial consent, randomisation, and treatment are performed by paramedics prior to hospitalisation. Patients with ultra-acute stroke (≤4 hours of onset) are randomised to transdermal GTN (5 mg/24 hours) or gauze dressing daily for 7 days. The primary outcome is systolic blood pressure at 2 hours. Secondary outcomes include feasibility, haemodynamics, dependency, and other functional outcomes. A nested qualitative study is included. Trial Status. The trial has all relevant ethics and regulatory approvals and recruitment started on February 15, 2010. The trial stopped recruitment in December 2011 after 41 patients were recruited. Trial Registration. The trial registration number is ISRCTN66434824 and EudraCT number is 2007-004766-40.
doi:10.1155/2012/385753
PMCID: PMC3480012  PMID: 23125943
3.  A Randomised Controlled Trial of Triple Antiplatelet Therapy (Aspirin, Clopidogrel and Dipyridamole) in the Secondary Prevention of Stroke: Safety, Tolerability and Feasibility 
PLoS ONE  2008;3(8):e2852.
Background
Aspirin, dipyridamole and clopidogrel are effective in secondary vascular prevention. Combination therapy with three antiplatelet agents might maximise the benefit of antiplatelet treatment in the secondary prevention of ischaemic stroke.
Methodology/Principal Findings
A randomised, parallel group, observer-blinded phase II trial compared the combination of aspirin, clopidogrel and dipyridamole with aspirin alone. Adult patients with ischaemic stroke or transient ischaemic attack (TIA) within 5 years were included. The primary outcome was tolerability to treatment assessed as the number of patients completing randomised treatment. Recruitment was halted prematurely after publication of the ESPRIT trial (which confirmed that combined aspirin and dipyridamole is more effective than aspirin alone). 17 patients were enrolled: male 12 (71%), mean age 62 (SD 13) years, lacunar stroke syndrome 12 (71%), median stroke/TIA onset to randomisation 8 months. Treatment was discontinued in 4 of 9 (44%) patients receiving triple therapy vs. none of 8 taking aspirin (p = 0.08). One recurrent stroke occurred in a patient in the triple group who was noncompliant of all antiplatelet medications. The number of patients with adverse events and bleeding complications, and their severity, were significantly greater in the triple therapy group (p<0.01).
Conclusions/Significance
Long term triple antiplatelet therapy was asociated with a significant increase in adverse events and bleeding rates, and their severity, and a trend to increased discontinuations. However, the patients had a low risk of recurrence and future trials should focus on short term therapy in high risk patients characterised by a very recent event or failure of dual antiplatelet therapy.
Trial Registration
Controlled-Trials.com ISRCTN83673558
doi:10.1371/journal.pone.0002852
PMCID: PMC2481397  PMID: 18682741

Results 1-3 (3)