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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03333980

Enrollment

Registered

2017-11-07

Start date

2017-05-01

Completion date

2017-11-06

Last updated

2017-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Brief summary

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

Detailed description

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

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).

Design outcomes

Primary

Measure	Time frame	Description
Compare functional assessment scores collected in this study with the preceding RN-CS-0001 study	12-months	Compare functional assessment scores collected in RN-CS-0002 with the preceding RN-CS-0001 study to better understand stroke symptom recovery and progress

Countries

United Kingdom

Outcome results