Observational Study of Ischaemic Stroke (OSIS)

Experience of conducting a Phase I study of an advanced medicinal therapy for ischaemic stroke and planning a Phase II efficacy study for this indication has revealed a number of opportunities to facilitate future clinical trials for this important indication.

Two key issues were identified which could be easily addressed with forward planning of future trials in the ischaemic clinical setting:

• The population readily available for clinical trials of potentially useful new agents is limited, as many patients presenting with a stroke are treated in an acute unit but then may "drop-out" of the acute neurology or academic catchment populations when they are transferred to a variety of settings for subsequent management, such as long-term hospital care in a geriatric ward, residential care or home care by relatives with assistance from social support. Thus, establishing a pool of patients willing to be contacted about future clinical trials after they leave the acute stroke facility would facilitate future stroke studies. It would ensure such patients were offered the opportunity to participate in relevant clinical trials and any additional related care (e.g. additional physiotherapy).
• Despite a substantial amount of literature on the management of stroke, planning of Phase II studies is still handicapped by insufficient information to clearly identify which patients will be left with residual disability and the time-course of any improvement with current standards of care. Optimal populations and clinical trial methodology for screening potential new interventions for stroke have not been established. Building a robust dataset to better identify such populations would: 1) improve the speed and reduce the cost of screening candidates, 2) permit use of more efficient statistical methods to screen for activity, and 3) increase the opportunity to identify new treatments for post stroke disability.

A core dataset will be recorded including the patient's National Health Service number, age, gender and stroke outcome measured by four standard validated rating scales; Action Research Arm Test (ARAT), National Institute of Health Stroke Scale (NIHSS), modified Rankin Scale (mRS) and Barthel Index (BI). All patients consenting to participate in the program would also consent to being contacted to determine their interest in participating in future regulated clinical trials of interventions for patients with a history of ischaemic stroke. The consent form for this study would make it clear that the patient is under no obligation to participate in any other study.

In addition to the core dataset, participating centres may elect to add additional sub-protocols to this study to collect additional non-core data: for example, assessment of cognitive or visual function, mood, fatigue or other measures of performance, structural or functional MRI imaging or other investigations related to the patient's progress following the presenting stroke. Additional assessment criteria outside the core dataset of this study would be the subject of centre-specific sub-protocols and must be approved as required by national and local requirements.

Co-recruitment of patients into other studies is allowable, if permitted within the other study protocol.