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Observational Study of Ischaemic Stroke (OSIS)

2016年12月16日 更新者:ReNeuron Limited

A Non-interventional Observational Study to Document the Clinical Course of Patients Following Ischaemic Stroke and to Establish a Pool of Patients for Future Trials in the Ischaemic Stroke Setting

The rationale for this study is to facilitate future Phase II/III clinical trials and improve outcome for patients suffering residual disability after an ischaemic stroke. Main study objectives are to document and better define the prognostic characteristics of residual disability in patients following an ischaemic stroke, to inform the design of small efficient Phase II studies when screening potentially efficacious interventions for signals of activity which merit further development and to establish a pool of patients who may be approached to participate in future clinical trials in the ischaemic stroke setting.

調査の概要

状態

完了

詳細な説明

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.

研究の種類

観察的

入学 (実際)

110

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

      • Glasgow、イギリス、G51 4TF
        • Glasgow Southern General Hospital

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

The group consists of consenting patients who survive the first 7 days following their first ischaemic stroke in participating stroke units

説明

Inclusion Criteria:

  • Capacity to give informed consent or witnessed informed consent in the event that the patient is unable to sign informed consent due to physical impairments
  • Clinical diagnosis of cortical and/or subcortical ischaemic stroke in an area perfused by the middle cerebral artery (i.e. stroke due to ischaemia resulting in infarct located in the basal ganglia, internal capsule or corona radiata)
  • Survived first 7 days following ischaemic stroke.
  • A motor handicap 7 days after the onset of the ischaemic stroke, which includes as a minimum, the inability to extend an arm to a horizontal position with the palm upward against gravity and to maintain the arm extended horizontally against gravity without obvious downward drift for 30 seconds.

Exclusion Criteria:

  • Prior history of stroke resulting in permanent, moderate to severe disability (i.e. Rankin Scale greater than 2) (other than the presenting ischaemic stroke)
  • Stroke due to haemorrhage
  • History of neurological or other disease resulting in significant functional impairment of the paretic arm impairing potential ability to pick up, lift and place a 2.5 cm3 block (e.g. Parkinson's disease, motor neuron disease, arthritis, Dupuytren's contracture or fixed anatomical abnormality)
  • Patient with a severe comorbid disorder, not expected to survive more than 12 months
  • Considered unlikely to be able to attend for all follow-up visits

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

この研究は何を測定していますか?

主要な結果の測定

結果測定
時間枠
Action Research Arm Test (ARAT)
時間枠:6 months
6 months
National Institute of Health Stroke Scale (NIHSS)
時間枠:6 months
6 months
modified Rankin Scale (mRS)
時間枠:6 months
6 months
Barthel Index (BI)
時間枠:6 months
6 months

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2014年2月1日

一次修了 (実際)

2016年3月1日

研究の完了 (実際)

2016年5月1日

試験登録日

最初に提出

2013年5月15日

QC基準を満たした最初の提出物

2013年5月17日

最初の投稿 (見積もり)

2013年5月22日

学習記録の更新

投稿された最後の更新 (見積もり)

2016年12月19日

QC基準を満たした最後の更新が送信されました

2016年12月16日

最終確認日

2016年12月1日

詳しくは

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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