Stroke trials

OBJECTIVES: This study sought to compare high dose versus low dose statin therapy in Indian patients with ST-segment elevation myocardial infarction (STEMI) undergoing thrombolysis. BACKGROUND: Randomized trials have demonstrated that statin treatment reduced major adverse cardiac events (MACEs) in patients with stable angina pectoris and acute coronary syndrome. However, randomized studies of statin therapy in Indian patients with STEMI are scarce. METHODS: Of 1859 patients with acute STEMI, 1027 eligible patients were randomized to 80-mg (n=512) or 10-mg (n=515) atorvastatin...

OBJECTIVE: To evaluate the literature regarding blood pressure control and management in older adult patient population over 70 years of age. METHODS: A literature search was conducted using PubMed and capturing the data from 2006 to 2016. Terms used included MeSH headings for hypertension/therapy and antihypertension agents. A systematic review of published studies was performed. Articles including older patients (average age 70 years or older) being treated for hypertension were included...

BACKGROUND: Children with sickle cell anemia (SCA) have an 11% risk of stroke by the age of 18. Chronic transfusion applied in patients detected to be at risk by transcranial Doppler allows a significant reduction of stroke risk. However, chronic transfusion exposes to several adverse events, including alloimmunization and iron overload, and is not curative. Hematopoietic stem cell transplantation allows termination of the transfusion program, but its benefit has not been demonstrated...

A Very Early Rehabilitation Trial (AVERT) was a Phase 3 randomized trial with over 2100 subjects post stroke that had unexpected results with better outcomes for usual care than those receiving very early mobilization. This review of published stroke clinical practice guidelines highlights that recommendations for mobilization have changed after publication of AVERT but also that developers have struggled to provide recommendations for appropriate dose, duration and intensity of mobilization in the acute post stroke period with available analyses from AVERT and other literature...

Cerebral venous thrombosis (CVT) is an important cause of stroke in young adults. Data from large international registries published in the past two decades have greatly improved our knowledge about the epidemiology, clinical manifestations and prognosis of CVT. The presentation of symptoms is highly variable in this disease, and can range from a patient seen at the clinic with a 1-month history of headache, to a comatose patient admitted to the emergency room. Consequently, the diagnosis of CVT is often delayed or overlooked...

OBJECTIVE: We aimed to conduct a systematic review and meta-analysis of prevalence and characteristics of poststroke depression (PSD) in sub-Saharan Africa (SSA). METHODS: We searched Medline, PsycINFO, and African Journals OnLine using keywords for stroke and depression and the .mp. operator for all 54 SSA countries/regions. Further information was retrieved through a manual search of references from relevant published and unpublished articles. We included only peer-reviewed original studies with epidemiological or experimental designs, conducted random-effect meta-analysis, and identified the most commonly associated factors by weight (inverse of variance method)...

Contemporary medical therapy consists of identification and treatment of all patient-modifiable vascular risk factors. Specific atherosclerotic disease therapies are designed to reduce the risk of thrombosis, and the disease progression in order to reduce the risk of future cardiovascular events. Contemporary medical management emphasizes the need to support the patient in achieving lifestyle modifications and to adjust medication to achieve individualized target values for specific quantifiable risk factors...

In the United States, 90% of carotid intervention is being performed for asymptomatic carotid stenosis, even though 90% of patients would be better treated with intensive medical therapy. This is being justified by comparing risks of stroke or death with medical therapy during clinical trials completed decades ago (approximately 2% per year) with risks of intervention with carotid artery stenting (CAS) versus carotid endarterectomy in recent trials that did not have a medical arm. Such extrapolations are, simply put, invalid...

Prior clinical trials produced evidence-based treatment recommendations for patients with asymptomatic carotid stenosis that may not be appropriate for clinical decision-making today. High-quality patient outcomes data to allow informed decision making regarding the optimal management of high-grade asymptomatic internal carotid artery stenosis is lacking. The results of the Asymptomatic Carotid Atherosclerosis Study were published in 1995 based on a randomized patient enrollment in the 1990s. Outcomes after endarterectomy, stenting, and medical treatment for these patients have all improved in the subsequent 2 decades...

BACKGROUND AND AIM: Post-stroke fatigue (PSF) is common and distressing, but there is insufficient evidence to recommend any effective treatment for it. Psychological interventions are effective in treating fatigue in other conditions. This paper describes the development and evaluation of the feasibility of a psychological intervention for PSF. METHODS: Based on psychological correlates of PSF and evidence-based psychological interventions for fatigue in other medical conditions, we developed a manualised psychological intervention for PSF, with input from stroke clinicians, psychological therapists, and stroke survivors...

OBJECTIVE: Dynamic tests of fluid responsiveness have been developed and investigated in clinical trials of goal-directed therapy. The impact of this approach on clinically relevant outcomes is unknown. We performed a systematic review and meta-analysis to evaluate whether fluid therapy guided by dynamic assessment of fluid responsiveness compared with standard care improves clinically relevant outcomes in adults admitted to the ICU. DATA SOURCES: Randomized controlled trials from MEDLINE, EMBASE, CENTRAL, clinicaltrials...

Erythropoietin (EPO) has been well known as a hematopoietic cytokine over the past decades. However, recent reports have demonstrated that EPO plays a neuroprotective role in the central nervous system, and EPO has been considered as a therapeutic target in neurodegenerative diseases such as ischemic stroke. Despite the neuroprotective effect of EPO, clinical trials have shown its unexpected side effects, including undesirable proliferative effects such as erythropoiesis and tumor growth. Therefore, the development of EPO analogs that would confer neuroprotection without adverse effects has been attempted...

BACKGROUND: Cardiovascular disease, which includes coronary artery disease, stroke and peripheral vascular disease, is a leading cause of death worldwide. Homocysteine is an amino acid with biological functions in methionine metabolism. A postulated risk factor for cardiovascular disease is an elevated circulating total homocysteine level. The impact of homocysteine-lowering interventions, given to patients in the form of vitamins B6, B9 or B12 supplements, on cardiovascular events has been investigated...

B vitamin therapy lowers plasma total homocysteine concentrations, and might be a beneficial intervention for stroke prevention; however, cyanocobalamin (a form of vitamin B12) can accelerate decline in renal function and increase the risk of cardiovascular events in patients with impaired renal function. Although early trials did not show benefit in reduction of stroke, these results might have been due to harm in participants with impaired renal function. In patients with diabetic nephropathy, cyanocobalamin is harmful, whereas B vitamins appear to reduce cardiovascular events in study participants with normal renal function...

Traditional methods of sample size and power calculations in clinical trials with a time-to-event end point are based on the logrank test (and its variations), Cox proportional hazards (PH) assumption, or comparison of means of 2 exponential distributions. Of these, sample size calculation based on PH assumption is likely the most common and allows adjusting for the effect of one or more covariates. However, when designing a trial, there are situations when the assumption of PH may not be appropriate. Additionally, when it is known that there is a rapid decline in the survival curve for a control group, such as from previously conducted observational studies, a design based on the PH assumption may confer only a minor statistical improvement for the treatment group that is neither clinically nor practically meaningful...

BACKGROUND: Treadmill training, with or without body weight support using a harness, is used in rehabilitation and might help to improve walking after stroke. This is an update of the Cochrane review first published in 2003 and updated in 2005 and 2014. OBJECTIVES: To determine if treadmill training and body weight support, individually or in combination, improve walking ability, quality of life, activities of daily living, dependency or death, and institutionalisation or death, compared with other physiotherapy gait-training interventions after stroke...

A significant number of clinical trials have been undertaken to explore the use of mesenchymal stem cells (MSCs) for the treatment of several diseases such as Crohn's disease, diabetes, bone defects, myocardial infarction, stroke etc., Due to their efficiency in homing to the tissue injury sites, their differentiation potential, the capability to secrete a large amount of trophic factors and their immunomodulatory effects, MSCs are becoming increasingly popular and expected to be one of the promising therapeutic approaches...

Background: Lipid metabolites may partially explain the inverse association between the Mediterranean diet (MedDiet) and cardiovascular disease (CVD).Objective: We evaluated the associations between 1) lipid species and the risk of CVD (myocardial infarction, stroke, or cardiovascular death); 2) a MedDiet intervention [supplemented with extra virgin olive oil (EVOO) or nuts] and 1-y changes in these molecules; and 3) 1-y changes in lipid species and subsequent CVD.Design: With the use of a case-cohort design, we profiled 202 lipid species at baseline and after 1 y of intervention in the PREDIMED (PREvención con DIeta MEDiterránea) trial in 983 participants [230 cases and a random subcohort of 790 participants (37 overlapping cases)]...

BACKGROUND: Sodium-glucose co-transporter 2 (SGLT2) inhibitors are a new pharmacotherapeutic class for the treatment of type 2 diabetes mellitus (T2DM). OBJECTIVE: To evaluate beneficial effects of the SGLT2 inhibitors on metabolic, cardiovascular, and renal outcomes. METHODS: A Pub-Med search (1966 to July 2017) was performed of published English articles using keywords sodium-glucose co-transporter 2 inhibitors, canagliflozin, dapagliflozin, and empagliflozin...

Stroke patients often suffer from severe upper limb paresis. Rehabilitation treatment typically targets motor impairments as early as possible, however, muscular contractions, particularly in the wrist and fingers, are often too weak to produce overt movements, making the initial phase of rehabilitation training difficult. Here we propose a new training tool whereby electromyographic (EMG) activity is measured in the wrist extensors and serves as a proxy of voluntary corticomotor drive. We used the Myo armband to develop a proportional EMG controller which allowed volunteers to perform a simple visuomotor task by modulating wrist extensor activity...