TIMES: Timed Interval Measurement of Eotaxin in Stroke Study

Sponsor

Royal Devon and Exeter NHS Foundation Trust (Other)

Overall Status

Completed

CT.gov ID

NCT03521882

Collaborator

(none)

Enrollment

Location

24.2

Actual Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke, Acute

Study Design

Study Type:

Observational

Actual Enrollment :

80 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Timed Interval Measurement of Eotaxin in Stroke Study

Actual Study Start Date :

May 22, 2017

Actual Primary Completion Date :

May 30, 2019

Actual Study Completion Date :

May 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Stroke Symptom Participants
Healthy Controls

Outcome Measures

Primary Outcome Measures

Primary Outcome [0 to 7 days]
Plasma Eotaxin Concentration

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Royal Devon & Exeter NHS Foundation Trust	Exeter	Devon	United Kingdom	EX2 5DW

Sponsors and Collaborators

Royal Devon and Exeter NHS Foundation Trust

Investigators

Principal Investigator: Salim Elyas, PhD MRCP, Royal Devon and Exeter NHS Foundation Trust

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Royal Devon and Exeter NHS Foundation Trust

ClinicalTrials.gov Identifier:

NCT03521882

Other Study ID Numbers:

Protocol v5 15/05/17

First Posted:

May 11, 2018

Last Update Posted:

Nov 6, 2020

Last Verified:

Nov 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Stroke

Study Results

No Results Posted as of Nov 6, 2020