A descriptive non-interventional study to evaluate the use of direct oral anticoagulants in UK clinical practice for patients with a first stroke attributable to nonvalvular atrial fibrillation.

Automatic Assessment of Gait Impairment and Recovery of Stroke using Smartwatch

A study to assess the clinical cost effectiveness of aphasia computer treatment versus usual stimulation or attention control long term post stroke (CACTUS)

Cavernomas A Randomised Effectiveness (CARE) pilot trial, to address the effectiveness of medical management versus medical and surgical management (with neurosurgery or stereotactic radiosurgery) in people with symptomatic brain cavernoma.

Stroke and Atrial fibrillation especially in South Wales are major diseases resulting in a significant social and economic burden. It has long been argued that AF and stroke unfavourably alter how the blood clots, however, there is no available test that can provide a numerical description of blood clotting quality in a clinical setting. The main goal of this observational study is to validate a novel test of clot quality, fractal dimension (df) in atrial fibrillation patients with and without stroke. This study aims to determine whether these patients are more likely to produce substantially modified clots that results in poorer clot quality and how these patients respond to anti coagulation (blood thinning) therapy. To do this a baseline blood sample will be taken for 2 different groups: atrial fibrillation patients suffering a stroke and atrial fibrillation patients without stroke. These patients will then receive oral anticoagulant therapy, following which a second sample will be taken to determine whether they improve clotting quality. The results of the second blood test will be compared to the results of their matched baseline for each participant to ascertain what effect oral anticoagulation has on clotting quality.

A Digital Speech Therapy Solution for Stroke, Brain Injury and Progressive Neurological Disorders: The Cog-Neuro Mobile Speech Therapy Solution

COMPOSEd is a study of patients’ and healthcare professionals’ experiences and opinions of diabetes and blood pressure management after a stroke.

This study evaluates the use of Colchicine in adults over 40 years of age who have suffered an ischaemic stroke or transient ischaemic attack NOT caused by cardiac embolism or other defined causes. Patients will be randomised to 0.5 mg/day of Colchicine plus usual care, or to usual care alone.
To investigate the efficacy of low dose colchicine (0.5mg/day) plus usual care (defined as antiplatelet, lipid-lowering, antihypertensive treatment, and appropriate lifestyle advice) compared with usual care alone to prevent non-fatal recurrent ischaemic stroke, myocardial infarction, cardiac arrest, hospitalization for unstable angina and vascular death after ischaemic stroke or transient ischaemic attack (TIA) not caused by cardiac embolism or other defined causes unrelated to atherosclerosis

CONVINCE – COLchicine for preventioN of Vascular Inflammation in Non-CardioEmbolic stroke) – a randomised clinical trial of low-dose colchicine for secondary prevention after stroke.

A Patient Reported Outcome Measure (PROM) is a questionnaire that asks patients for their views on their own health or the impact of healthcare they have received on their health and quality of life\n\nThere is a PROM (the PROMIS-10 Global Health) and a number of extra questions that are recommended for use in people who have had a stroke by the International Consortium for Health Outcomes Measurement, but the best way of delivering these questions for stroke survivors is unknown.\n\nAt present, the NHS in England, Scotland and Wales are required to offer every stroke survivors a 6 month post stroke follow-up appointment. Currently, the information collected at this 6 month review is not from the patient’s perspective and the best method of collecting this information has not been established.\n\nThe aim of this research is to understand if there is a difference between 4 methods of administration using a grouping of Patient Reported Health Status Questions (PRHSQs) in people who have had a stroke. \n\nThe four methods of administration are: \n\n-\tFace-to-Face\n-\tTelephone\n-\tOnline\n-\tPost\nTo conduct this research study four initial Principal Investigators in 4 sites have agreed to take part. Aneurin Bevan Health Board will hold 3 sites and Cwm Taf University Health Board will hold 1 site. Between each site a sample of 808 eligible stroke survivors will be asked to take part. From these 808 people, 202 participants will be randomly assigned to each method of administration. \n\nThe study data collection will run concurrent from 1st June 2017 to 31st December 2017. \n\nThe conclusions of this research will inform the roll-out of the most appropriate method of delivering the 6 month stroke follow-up review for stroke survivors.

The ELAN trial aims to estimate the net benefit of early versus late (current standard practice) initiation of direct oral anticoagulants (DOACs) in patients with acute ischaemic stroke related to atrial fibrillation.

ENCHANTED is an independent, investigator initiated, international collaborative, quasi-factorial randomised controlled trial involving a package of 2 linked comparative randomised treatment arms, which aims to address 4 key questions in patients eligible for thrombolysis in the acute phase of ischaemic stroke. (1) Does low-dose (0.6 mg/kg) intravenous (i.v.) recombinant tissue plasminogen activator (rtPA) provide equivalent benefits compared to standard-dose (0.9 mg/kg) rtPA? (2) Does intensive blood pressure (BP) lowering (130-140 mmHg systolic target) improve outcomes compared to the current guideline recommended level of BP control (180 mmHg systolic target)? (3) Does low-dose (0.6 mg/kg) intravenous (i.v.) recombinant tissue plasminogen activator (rtPA) reduce the risk of symptomatic intracerebral haemorrhage (sICH)? (4) Does the addition of intensive BP lowering to thrombolysis with rtPA reduce the risk of any intracerebral haemorrhage (ICH)?

EdoxabaN foR IntraCranial Haemorrhage survivors with atrial fibrillation (ENRICH-AF)

After a severe stroke, prognosis is often poor and consequently high quality end-of-life care is very important. Recognising that a person may be in the final phase of life is very difficult and end-of-life care conversations can be delayed. This means that peoples’ end-of-life care wishes and needs may not be identified until the very end of life. Yet at this point it may be too late address particular wishes and/or needs. The transition to end-of-life care could be eased through excellent, sensitive communication and advance care planning. At a time when life expectancy may be cut short this may improve patients’ and families’ experiences of care, enhance care quality, quality of life and family outcomes.

This study aims to understand end-of-life care in severe stoke in the stroke ward setting from the standpoint of bereaved family members of people who died before and after the introduction of an advance care planning staff training intervention. We will use face-to-face interviews with up to 16 bereaved family members of people who died in the hospital stroke ward following a severe stroke. Interviews will take place either in participants’ own homes or in the University. We hope the findings will help us to better understand bereaved families’ experiences of end-of-life care and the effect, if any, of staff training to improve advance care planning. This is important as currently we know very little about end of life care in stroke wards and the extent to which this care is consistent with UK and Welsh Government policy and guidance. This study will enable a foundation for enhancing end-of-life care in severe stroke in acute hospital settings and use of advance care planning and the new All Wales Care Decisions for the Last Days of Life guidance.

Stroke in Young Adults: What is the metabolic and mechanical cost of walking of working and what are the implications for rehabilitation?

This research study led by Dr Hannah Jarvis and Professor Neil Reeves from Manchester Metropolitan University and funded by the Stroke Hub Wales aims to investigate how a stroke in young adults affects the energy required to walk (known as the metabolic cost of walking) compared to able-bodied age-matched controls that have not experienced a stroke and to understand the underlying mechanisms for potential impairments in their gait pattern. This research study has captured energy expenditure, joint kinematics and kinetics during walking and quality of life of young adults who have had a stroke and compared to healthy able-bodied controls. The outcome of this research will be used to inform rehabilitation guidelines specific for younger adults following stroke. This research study is registered on the NIHR portfolio (CPMS – 39832).

A mixed-methods evaluation of an adapted Acceptance and Commitment Therapy (ACT) group for stroke survivors and their carers: ACTivate Your Life After Stroke.\n\nN.B. Please note change of name from ’ACTion after Stroke’ to ’ACTivate your life after stroke’. The former name appears on the sponsors letter, however the documents provided for review are the same. The name was changed to remain consistent across all research sites.

A study of the predictive nature of Extracellular Vesicles in a transient ischemic attach patient cohort.

The FOCUS trial is aims to establish whether a six month course of fluoxetine, started within the first 15 days after an acute stroke, improves patients recovery over the first year. Also whether the treatment is cost effective (i.e. that any costs associated with the treatment are offset by health gains, and or reductions in healthcare and social care costs. This research aims to improve the care received by NHS patients and the use of NHS resources. Recruitment to the trial closed on the 31st March 2017. 3127 participants were recruited to the trial. The final patient and GP follow-ups for the patients recruited on the 31st March 2017 are due on 31st March 2018.

Genetic risk factors for cerebral small vessel disease.

This study is an investigator-initiated and conducted, international collaborative, regionally organised, multicentre, prospective, cluster randomised, crossover, blinded outcome assessment study to compare the effectiveness of the lying flat (0°) head position with the sitting up (=30°) head position, in the first 24 hours of admission to hospital for patients with acute stroke, on the poor outcome of death or disability over the subsequent 90 days.

Liverpool-Heart and bRain Project

Given the advances in the management of atrial fibrillation (an irregular heart rhythm), especially the new medications for stroke prevention, and the availability of new European Society of Cardiology (ESC) clinical guidelines, there is a need for the systematic collection of contemporary data regarding the management and treatment of atrial fibrillation. There is currently a registry collecting data on how cardiologists (specialists in conditions of the heart) manage and treat patients with atrial fibrillation in 55 countries in Europe. Data is being collected on how cardiologists in the UK manage patients with atrial fibrillation. However, in the UK, patients with atrial fibrillation are also managed by other doctors, particularly their general practitioner (GPs), accident and emergency (A&E) doctors (when admitted to hospital), stroke doctors (when atrial fibrillation is diagnosed after a stroke has occurred) and by acute medicine doctors (as atrial fibrillation is more common among people aged 65 years and older). This study will allow us to compare how patients with atrial fibrillation are managed by heart specialists (cardiologists) and other doctors (non-heart specialists). The purpose of collecting this data is to see if atrial fibrillation patients are managed in line with clinical guidelines. In this UK extension study we will recruit up to 1650 atrial fibrillation managed by GPs, cardiologists, A&E, stroke, and acute medicine doctors. Demographic (e.g. age, sex, ethnicity etc.) and clinical (e.g. other health problems, medications, operations etc.) information will be recorded at baseline and then the patient will be followed up 12 months later to see how their healthcare is managed over time. The follow-up will involve the patient visiting the hospital and/or review of their medical records and/or telephone call with the patient or their GP, according to the usual practice of the medical specialty who is managing the patient.

This feasibility study is the 5th of five work streams funded by an NIHR Programme Grant to develop and evaluate key aspects of a replicable system of longer-term service delivery ‘care strategy’. The emphasis is on improving quality of life by addressing unmet needs and enhancing participation. In previous workstreams, work has focused on development of an intervention, to be delivered by community-based staff, called ‘New Start’

The Metoclopramide for Avoiding Pneumonia after Stroke (MAPS-2) Trial: a single-blind, randomized controlled trial of metoclopramide for the prevention of pneumonia in patients with dysphagia after an acute stroke.

OPTIMAS is a large, prospective, partially blinded randomised controlled trial of early (within ≤4 days [96hrs]) or standard (between day 7 and day 14 after stroke onset) initiation of anticoagulation after stroke in patients with atrial fibrillation (AF), using any licensed dose of a direct oral anticoagulant (DOAC). The trial will use a non-inferiority gatekeeper approach to test for non-inferiority of early anticoagulation followed by a test for superiority, if non-inferiority is established.

HPS-4/TIMI 65/ORION-4: A double-blind randomized placebo-controlled trial assessing the effects of inclisiran on clinical outcomes among people with atherosclerotic cardiovascular disease.

Paramedic Acute Stroke Treatment Assessment – This research study is a clinical trial to determine whether a Paramedic Acute Stroke Treatment Assessment (PASTA) pathway can speed up access to emergency stroke treatments, especially thrombolysis treatment, and so improve recovery after stroke. Participants receive either usual emergency stroke care or the additional PASTA pathway.

PREPARE: imPRoving End of life care Practice in stroke cARE.

https://www.nottingham.ac.uk/research/groups/stroke/clinical-stroke-trials/index.aspx

Publication link:

Restart or stop antithrombotics randomised trial. For adults surviving spontaneous (non-traumatic) intracerebral haemorrhage (ICH) who had taken and antithrombotic (ie anticoagulant or antiplatelet) drug for the prevention of vaso-occlusive disease before ICH, does a policy of starting antiplatelet therapy result in a beneficial net reduction of all serious vascular events over two years compared with a policy of avoiding antiplatelet therapy?

The RETAKE study is a four-year study that aims to determine whether early stroke specific vocational rehabilitation (ESSVR) in addition to usual NHS rehabilitation (UC) is more effective and cost effective at returning stroke survivors to work and keeping them there at 12 months post-randomisation than UC alone.

Rapid intervention with glyceryl trinitrate in hypertensive stroke trial – assessment of safety and efficacy of transdermal GTN, and the feasibility of a multicentre ambulance-based stroke trial

To discover outcomes of patients treated with Rivaroxaban with atrial fibrillation with at least one additional investigator-determined risk factor for stroke in real-life practice.

In patients receiving a factor Xa inhibitor who are experiencing an acute major bleed, the objectives of this study are to demonstrate the decrease in anti-fXa activity and to evaluate hemostatic efficacy following andexanet treatment.

The SC IL-1Ra in SAH study aims to test whether a drug called Kineret^® can improve recovery following aSAH. This has the potential to make a profound difference to quality of life following haemorrhagic stroke.

Bleeding within the skull, also known as brain haemorrhage, affects 3 million people in the world each year.

One in five people who survive brain haemorrhage have an irregular heart rhythm called ‘atrial fibrillation’, which puts them at risk of stroke and other blood clots.

Blood-thinning medicines, known as ‘anticoagulant’ drugs, are used in everyday clinical practice to protect people with atrial fibrillation from developing blood clots. However, these drugs also increase the risk of bleeding and are usually stopped when the brain haemorrhage occurs.

But when patients recover from brain haemorrhage, they and their doctors are often uncertain about whether to start or stop these drugs to prevent further clots occurring, or whether to avoid them in case they increase the risk of brain haemorrhage happening again.

Investigators want to find out whether starting or not starting an anticoagulant drugs is better for those patients.

A network of hospital doctors, nurses, and other staff will identify people who survive brain haemorrhage and have atrial fibrillation. If a patient and their doctor are uncertain about whether to start an anticoagulant drug, they may invite the patient to participate.

In the pilot phase, investigators aim to recruit at least 60 participants to determine the feasibility of recruiting the target sample size of at least 800 participants in the main phase of the trial.

Investigators will follow-up all participants for at least one year to determine whether prescribing an anticoagulant drug reduces the occurrence of all serious vascular events like heart attack, stroke compared with a policy of avoiding oral anticoagulant.

Stroke in Young Adults: What is the metabolic and mechanical cost of walking of working and what are the implications for rehabilitation?

This research study led by Dr Hannah Jarvis and Professor Neil Reeves from Manchester Metropolitan University and funded by the Stroke Hub Wales aims to investigate how a stroke in young adults affects the energy required to walk (known as the metabolic cost of walking) compared to able-bodied age-matched controls that have not experienced a stroke and to understand the underlying mechanisms for potential impairments in their gait pattern. This research study has captured energy expenditure, joint kinematics and kinetics during walking and quality of life of young adults who have had a stroke and compared to healthy able-bodied controls. The outcome of this research will be used to inform rehabilitation guidelines specific for younger adults following stroke. This research study is registered on the NIHR portfolio (CPMS – 39832).

When someone has a stroke caused by bleeding into the brain (haemorrhagic stroke) permanent brain damage can occur and result in long-term disability. There is also a chance that the bleeding can increase, which may cause worse disability or be life threatening. This happens in approximately 20-30% of haemorrhagic stroke patients. At present there is no available treatment that is effective at reducing the bleeding in the brain and improving the recovery. In this trial, we want to test whether it is possible to give a drug (tranexamic acid) to people in the first few hours after a haemorrhagic stroke. We hope that we will be able to show that giving the drug may reduce the chances of dying and being left with disability after a haemorrhagic stroke. In this trial, the treatment we are testing is a drug, tranexamic acid, which encourages blood to clot to stop the bleeding. Continued or increased bleeding into the brain (haematoma expansion) is not uncommon in the first hours and days following a haemorrhagic stroke and increases the risk of the patient not recovering fully and being left with some disability. Stopping the bleeding in the first hours and days after stroke with medicine might help patients to recover better. Tranexamic acid is a tried and tested drug in other medical conditions that acts quickly to help the blood to clot and stop bleeding but is not given routinely after stroke. The aim of this study is to assess what effect tranexamic acid has on how people recover after a haemorrhagic stroke.

Treatment in Morning versus Evening (TIME) is a study to compare the treatment for high blood pressure using hypertensive drugs given in the evening with the usual morning medication. This is done using an online system to record any side effects or changes due to the change in their medication. This automated system has worked well in our initial phase of this study with good patient response. Record-linkage to hospitalisations and deaths will be carried out and events monitored. Heart attack, stroke or death will be recorded and analysed to see if the timing of the medication has any impact.
Publication link:

Quality of Life (QoL) for people with disabling neurological conditions is affected by a range of factors, which have received considerable previous research attention. However clinicians’ knowledge could be enhanced by two areas of additional enquiry.

Quality of Life (QoL) for people with disabling neurological conditions is affected by a range of factors, which have received considerable previous research attention. However clinicians’ knowledge could be enhanced by two areas of additional enquiry.

Quality of Life (QoL) for people with disabling neurological conditions is affected by a range of factors, which have received considerable previous research attention. However clinicians’ knowledge could be enhanced by two areas of additional enquiry.

A Sub-Study of an investigator initiated and conducted, multicentre, international, double-blinded, placebo-controlled, parallel-group, randomised controlled trial (TRIDENT) to determine the effect of more intensive long-term blood pressure control, provided by a fixed low-dose combination blood pressure lowering pill (“Triple Pill”) strategy on top of standard of care, for slowing memory decline as measured by Cambridge Neuropsychological Test Automated Battery (CANTAB), in patients with a history of acute stroke due to intracerebral haemorrhage (ICH).

A randomised controlled trial of scanning eye training as a rehabilitation choice for hemianopia after stroke (SEARCH).