Timed Interval Measurement of Eotaxin in Stroke Study

NCT03521882 | Completed

• 1 other identifier: Protocol v5 15/05/17
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke is caused by sudden changes in blood flow in the brain. This can be fatal or can result in permanent disability. A fast diagnosis is essential to initiate effective interventions and optimize benefits to patients. There are other diseases that can look like a stroke and these are called "stroke mimics". The quicker that stroke mimics can be ruled out the faster a stroke can be diagnosed and treatment can be given. The investigators may be able to use chemicals in the blood to rapidly confirm that a person has had a stroke. One such chemical is called eotaxin. Eotaxin has been found to be changed in sufferers of a stroke but not in those with stroke mimics. However, more research is needed to confirm the usefulness of eotaxin. This feasibility study aims to provide the foundations to allow a large scale trial of this test. The study aims to recruit participants that have had a stroke or a stroke mimic from the Acute Stroke Unit and Stroke clinic at the Royal Devon and Exeter Hospital. Up to 6 blood samples will be taken from each participant at different times over one week. Eotaxin will be measured in these samples and in participant's leftover samples taken for clinical care. This is needed because the investigators know that the amount of eotaxin changes in the blood after a stroke but we do not know how quickly this change happens and for how long the change occurs. The study will also allow the investigators to understand how many participants will be needed for a large scale trial and the challenges that may be faced in recruiting participants.

Conditions

Stroke, Acute

Outcome Measures

Primary Outcomes (1)

• Primary Outcome

  Plasma Eotaxin Concentration

  0 to 7 days

Study Arms (2)

Stroke Symptom Participants

Healthy Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals presenting to hospital with focal neurological symptoms suggestive of stroke aged over 18 years.

You may qualify if:

• Presenting with focal neurological symptoms suggestive of stroke
• Aged over 18 years

You may not qualify if:

• Presenting later than 12 hours after symptom onset
• Under 18 years of age
• History of cardiovascular disease (Healthy Controls)
• History of neurological disease (Healthy Controls)
• History of stroke mimics (Healthy Controls)

Sponsors & Collaborators

• Royal Devon and Exeter NHS Foundation Trust: lead

Study Sites (1)

Royal Devon & Exeter NHS Foundation Trust

Exeter, Devon, EX2 5DW, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Salim Elyas, PhD MRCP

  Royal Devon and Exeter NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2018
• First Posted: May 11, 2018
• Study Start: May 22, 2017
• Primary Completion: May 30, 2019
• Study Completion: May 30, 2019
• Last Updated: November 6, 2020

Record last verified: 2020-11

Locations

GB (1)