1301728 / Enhanced Control of Hypertension and Thrombolysis Stroke Trial
Analysis of specimens from patients with painful metal on metal hip replacements (Study due to close 30/04/2018)
1407967 / Predicting Language Outcome and Recovery After Stroke
The aim of the study is to provide a clinical protocol that will Predict Language Outcome and Recovery After Stroke (PLORAS). The system we are developing takes a structural brain image of a new patient with language difficulties (aphasia) and produces probabilistic estimates of long term outcome, based on whether, when, and in what respects, other patients with “matching” lesions recovered their speech and language abilities.
The project rests on a database that records three types of information from many hundreds of stroke patients: language scores (from standardised assessment), structural MRI, and demographic information (age, time post stroke etc). Critical lesion sites for aphasic symptoms are identified by linking structural MRI and language scores. A combination of all data types then enters the PLORAS system, which predicts recovery from aphasia in new patients. In order to be successful, we need to study large numbers of patients who have had a stroke, some of whom have continuing problems with their language and some who don’t. The information from this study will enable us to make predictions about likely recovery patterns in patients who suffer strokes in the future. This will help guide both clinical and experimental therapeutic interventions. (Study due to close 30/07/2022)
1411004 / Investigation of the Prevalence of Anderson- Fabry Disease in at risk populations
A national, multicentre, prospective study to screen populations of patients defined as ‘at risk’ for Lysosomal Storage Disease, Fabry disease.
Given the phenotypic heterogeneity of patients with Fabry disease it is likely that some patients with isolated manifestations may remain undiagnosed in organ specific specialist clinics. This study aims to investigate the prevalence of the condition in defined high risk groups and to identify patients who may benefit from specialized management in the context of lysosomal storage disorders unit. This is a diagnostic study. Once consented, patients will be required to see their Study Doctor for one study visit. Clinical presentation data and a blood sample will be taken for analysis for diagnosis of Fabry disease. Any patient given a provisional diagnosis of AFD will be referred to a national Lysosomal Storage Disorders unit for clinical assessment, counselling, and confirmation of the diagnosis and appropriate management. (Study due to close 31/12/2018)
1411009 / ECST 2
ECST 2: The 2nd European Carotid Surgery Trial (Study due to close 31/03/2022)
1605252 / TASTE
The primary objective of this study is to test the hypothesis that patients with acute hemispheric ischaemic stroke who have a penumbra on perfusion CT or MRI within 4.5 hours of symptom onset will have less disability at 3 months when treated with IV TNK compared to IV tPA. (Study due to close 31/12/2019)
1703392 / PD COMM
Parkinson’s disease (PD) is a common movement disorder, affecting approximately 120,000 people in the UK. Over two thirds of people with PD report having speech related problems which has a great impact on their lives, leading to increased physical and mental demands during conversation, reduced independence and social withdrawal. (Study due to close 30/11/2018)
1707455 / Start or STop Anticoagulants
Start or STop Anticoagulants (Study due to close 22/07/2022)
1711531 / SPA
Beyond language function, people with aphasia (PWA) report a range of health problems which negatively affect wellbeing, including reduced confidence and social isolation. These psychosocial outcomes of aphasia are not sufficiently met by healthcare services: improvements in language function do not appear to lead to improvements in wellbeing. National clinical guidelines for stroke reflect this observation and highlight the need for community integration and participation of people with aphasia. This research is about singing groups for people with aphasia (SPA) and is intended to address this need by focusing on the wellbeing and social participation needs of people with aphasia after stroke.
Our engagement activities and early development project provided strong impetus for the proposed study: people with aphasia who we spoke with repeatedly told us that singing in groups may help them to reconnect with society, and that this will improve their wellbeing.
We have planned a pilot study that will allow us to assess the extent to which the study processes and the singing groups themselves are feasible to run and are acceptable to participants. The information we get from this work will help us to decide whether we can go on to conduct a larger randomised controlled trial (RCT) which would be a fair test of whether SPA can improve the lives of individuals with post stroke aphasia. (Study due to close 30/06/2018)
1711537 / Genetic risk factors for cerebral small vessel disease
Disease of the small blood vessels in the brain (SVD) is an important cause of stroke, cognitive impairment and dementia. Therefore SVD is a major public health problem. Researchers do not yet fully understand what causes SVD and this is an important reason why there are no specific therapies to delay its progression. Genetic studies provide the opportunity to identify entirely novel disease mechanisms and thereby may allow us to develop new treatment approaches. In addition, the identification of novel genes might allow us to identify individuals at high risk in whom we could institute specific treatments or particularly intensive risk factor prevention.
However, previous large-scale genetic studies have been largely unsuccessful in SVD, which is probably due to inadequate phenotyping of SVD, disease heterogeneity and relatively small sample sizes.
This study is part of a larger project, recently funded by a British Heart Foundation programme grant awarded to Professor Hugh Markus. We are going to study the genetic basis of SVD defined using detailed phenotyping. We are going to perform a Genome Wide Association Study, which can identify up to one million variants across somebody’s genomes. In addition we are going to apply powerful new computer methods that make efficient use of disease heterogeneity. In this study we aim to increase the sample size by recruiting another 1000 MRI-defined SVD stroke cases and thereby to increase the ability to detect novel genes. Details about the stroke, cardiovascular risk factors, family history and other health details will be collected and 10 ml of blood will be taken from a vein. (Study due to close 01/11/2021)
1803562 / ESUS
Design: Investigator Initiated Longitudinal Prospective Observational Patient Registry
Background: Around 20% of strokes are investigated and no cause found. It has been suggested that these can be characterised as ‘Embolic Stroke of Undetermined Source’ or ESUS. Currently little is known about this type of stroke, especially in young people.
Aims: The purpose of the registry is to better understand the characteristics of ESUS in young patients, to determine; how often a second stroke occurs; mortality rate; and if possible what factors contribute to a second stroke.
Population and Location: We will recruit between 500-1000 patients from approximately 100 hospitals in 13 countries around the world. Between 80- 130 of these patients are expected to be recruited in the UK across 13 sites.
Methods: Patients will be approached when they are in hospital or when they are seen in stroke follow up clinics. If they consent to take part then information about them and their stroke will be collected in a short interview and from their medical notes. Patients will be contacted by telephone every 6 months, up to 18 months post stroke. The follow
up phone calls will be brief and will just be to see how they are recovering from their stroke and if they have had any further events or relevant new diagnosis. The patients recruited will not undergo any additional treatment, diagnostic tests or have any change in their medical care due to taking part. (Study due to close 30/09/2019)
1807653 / SIGNUM
Stroke is the third most common cause of death and the most common cause of adult disability world-wide. It is a sudden interruption of blood supply to part of the brain, either due to blockage (ischaemia) or bleeding (haemorrhage), resulting in damage to the brain. The consequence of this will be disability, be it in thinking, movement or speech.
Fundamental questions remain unanswered in stroke. First, stroke is still thought of in the broad categories of ischaemia and haemorrhage.
However, it is well known that many subtypes exist within these categories. We can now reliably identify these with advanced scanning techniques. We now need to investigate if the biological causes and consequences of these subtypes are different. Understanding this will help us prevent stroke from occurring and help us limit damage at the time of a stroke (therefore limiting disability).
The second and related question is addressing recovery from stroke, which is a focus of this project. There may be differences in the way in which different subtypes of stroke recover. Moreover there may be treatments that could be particularly beneficial for one subtype compared to another. We now need to redefine stroke according to subtype, map prognosis and identify time points at which interventions may be most useful to improve disability. In this study we will establish a collection of stroke patients; we will use health information collected as part of routine care on the clinical stroke service.
We will follow-up patients to map trajectories of recovery according to stroke subtype. We will then assess factors, both behavioural and blood based, that may affect prognosis of stroke by subtype. If these factors can be manipulated at the right time, either by behaviours or drugs, we may be able to discover and offer new treatments for stroke (Study due to close 31/08/2019)
1807654 / CONVINCE
CONVINCE-A randomised clinical trial of low dose colchicine for secondary prevention after stroke.
Patients who have recently had a stroke or transient ischemic attack may be invited to take part in the CONVINCE Study.
To reduce the risk of another stroke, the standard care often includes medicine that slows clotting (e.g aspirin), reduces cholesterol (e.g statins), and lowers blood pressure. The purpose of this study is to compare an anti-inflammatory medication called colchicine used with standard treatment to standard treatment is no placebo medication
This is a research study because colchicine has not yet been proven to prevent stroke/heart attack after stroke. It is expected that about 2623 patients from at least 5 countries will participate.
The study medicine is colchicine. It works by blocking the action of proteins (tubilins) that play important roles in inflammation. Inflammation increases the risk of stroke and heart attack.
At low doses similar to the dose in this study, colchicine has been safely used for many years in the treatment of joint diseases, such as gout and Familial Mediterranean Fever. It is taken by mouth, once a day with a glass of water. The dose in the study is 0.5 mg (one tablet per day)
Participants will be followed for 12-60 months.
Participants will be asked to attend clinic visits at 1 month and every 6 months until the end of the study. At each visit study staff will:
If assigned to colchicine, check that the participant is taking it and other medicines.
Collect information about any new medical problems , or possible side effects from medicines.
Provide the participant with a new supply of colchicine, if they are assigned to it.
Check heart rate, blood pressure and level of independence.
A blood test will be taken at the first visit and once per year thereafter.
This research is funded by the Health Research Board of Ireland. (Study due to close 30/10/2021)
1808655 / TRIDENT
Intracerebral haemorrhage (ICH) is the most serious and least treatable form of stroke. It affects at least 1 in 10 out of the 20 million new strokes that occur in the world each year. Survivors of ICH are at risk of another stroke. Blood pressure (BP) lowering is an important method to prevent another stroke but – despite strong evidence in support of
BP lowering – data show that BP is poorly controlled in these patients.
TRIDENT will investigate whether an approach that uses a ‘Triple Pill’ strategy (a single capsule containing three low dose BP-lowering drugs) in ICH patients with mild to moderate hypertension can reduce the risk of recurrent stroke when compared with placebo medication in adults (≥18 years) with a history of CT-confirmed primary ICH of up to 6 months after the onset of symptoms. 4,200 participants will be randomised in this international trial to either a Triple Pill or Placebo Pill for 36 months follow-up
after a 14 day active run-in phase in which all potential participants will receive the Triple Pill. (Study due to close 01/05/2020)
1808670 / STROLLERS
Stroke is a major cause of death and disability worldwide. In the UK, there are over 1.2 million people living with the consequences of a stroke. Post-stroke impairments have a profound impact on quality of life after stroke, with around two thirds of stroke survivors reporting reduced participation in pre-stroke valued leisure activities. Although the importance of return to pre-stroke valued activities is recognised in national clinical guidelines for stroke, there is evidence to suggest that the focus of stroke rehabilitation remains oriented towards recovery of physical function (e.g. improving activities of daily living (ADLs) and mobility), rather than supporting individuals to return to previously valued social and leisure activities.
The aim of this study is to examine changes in leisure participation after stroke. People experiencing a new first or recurrent transient ischaemic attack (TIA) or stroke will be invited to take part in the study whilst an in-patient, or at a first post event TIA clinic appointment. Consenting patients will be asked to complete two questionnaires (i) a baseline questionnaire to gather data on frequency of participation in leisure activities in the few weeks prior to their stroke and (ii) a six month follow-up questionnaire to gather data on frequency of participation in leisure activities in the few weeks prior to completion of the questionnaire.
The Shortened Nottingham Leisure Questionnaire is the primary measure for the study. A sub-sample of consenting participants, who return both baseline and follow-up questionnaires, will be invited to take part in a telephone interview to discuss in greater detail their responses in the questionnaires. Maximum variation sampling will be employed to ensure that a range of experiences of return to leisure for people after stroke are represented. (Study due to close 01/12/2018)
1808672 / FIRST Registry
We intend to study the incidence of long term complications (venous thromboembolism (VTE), post thrombotic syndrome and chronic thrmoboembolic pulmonary hypertension) for VTE patients treated with rivaroxaban without bridging heparin (up to 5 years) in routine clinical practice (no additional actions will be required other than routine clinical practice of the treating hospital or GP practice). (Study due to close 31/10/2020)