An Ischaemic Stroke Observational Study

NCT ID: NCT03333980

Last Updated: 2017-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

39 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-01

Study Completion Date

2017-11-06

Brief Summary

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A non-interventional observational clinical study to document the clinical course of patients at 12 months or more following an ischaemic stroke

Detailed Description

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Primary objective:

To document and better define the prognostic characteristics of residual disability 12 months or more following an ischaemic stroke in patients that originally participated in the preceding clinical study RN-CS-0001.

Other objective:

To inform the design of efficient Phase 2/3 studies when screening potentially efficacious interventions for signals of activity which merit further development.

Conditions

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Stroke

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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.
* Participation in the preceding study RN-CS-0001
* Completion of at least one of the 4 functional assessment tests (ARAT, BI, NIHSS, mRS) at any time point on the previous study RN-CS-0001
* Ability to participate in all assessments and attend all visits

Exclusion Criteria

* Any additional incidence of stroke (Ischaemic or Haemorrhagic) since participation in the previous study RN-CS-0001 (since the last CS-0001 assessment visit date).
* Incidence of significant other disease that judged by the investigator would confound completion of all functional assessments (not excluding patients that can complete at least one functional assessment with no confounding factor from significant other disease).
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ReNeuron Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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New Queen Elizabeth Hospital

Birmingham, , United Kingdom

Site Status

Ninewells Hospital & Medical School

Dundee, , United Kingdom

Site Status

Queen Elizabeth University Hospital.

Glasgow, , United Kingdom

Site Status

University College London Hospital Stroke Research Centre

London, , United Kingdom

Site Status

The University of Manchester Institute of Cardiovascular Research

Manchester, , United Kingdom

Site Status

Nottingham City Hospital

Nottingham, , United Kingdom

Site Status

University Hospital Southampton NHS Foundation Trust

Southampton, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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RN-CS-0002

Identifier Type: -

Identifier Source: org_study_id