An Ischaemic Stroke Observational Study
A Non-interventional Observational Clinical Study to Document the Clinical Course of Patients 12 Months or More Following an Ischaemic Stroke
1 other identifier
observational
39
1 country
7
Brief Summary
A non-interventional observational clinical study to document the clinical course of patients at 12 months or more following an ischaemic stroke
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2017
Shorter than P25 for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2017
CompletedFirst Submitted
Initial submission to the registry
September 26, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 6, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 6, 2017
CompletedFirst Posted
Study publicly available on registry
November 7, 2017
CompletedDecember 5, 2017
December 1, 2017
6 months
September 26, 2017
December 1, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Compare functional assessment scores collected in this study with the preceding RN-CS-0001 study
Compare functional assessment scores collected in RN-CS-0002 with the preceding RN-CS-0001 study to better understand stroke symptom recovery and progress
12-months
Eligibility Criteria
All patients assessed as part of the preceding study RN-CS-0001 which forms the list of potential patients for this study.
You may qualify if:
- 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
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ReNeuron Limitedlead
Study Sites (7)
New Queen Elizabeth Hospital
Birmingham, United Kingdom
Ninewells Hospital & Medical School
Dundee, United Kingdom
Queen Elizabeth University Hospital.
Glasgow, United Kingdom
University College London Hospital Stroke Research Centre
London, United Kingdom
The University of Manchester Institute of Cardiovascular Research
Manchester, United Kingdom
Nottingham City Hospital
Nottingham, United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2017
First Posted
November 7, 2017
Study Start
May 1, 2017
Primary Completion
November 6, 2017
Study Completion
November 6, 2017
Last Updated
December 5, 2017
Record last verified: 2017-12