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Bayraktutan Dunhill Medical Trust EPC Study

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ClinicalTrials.gov Identifier: NCT02980354
Recruitment Status : Recruiting
First Posted : December 2, 2016
Last Update Posted : May 3, 2019
Sponsor:
Collaborator:
The Dunhill Medical Trust
Information provided by (Responsible Party):
University of Nottingham

Brief Summary:
Stroke is a life-threatening medical condition that occurs due to a sudden disruption of blood supply to the brain. Although it may affect all age groups including children, the elderly are at a greater risk of having strokes. Indeed, three-quarter of all strokes are seen in people over the age of 65. Unfortunately, due to short therapeutic window (4.5 h of stroke onset), only 2-3% of patients can receive the currently available single medical therapy with rt-PA, a clot-busting agent. As recent studies show that bone marrow-derived endothelial progenitor cells, a type of stem cells, may migrate to the site of injury to repair the damaged brain vessels and tissue, it is possible that their numbers and functional capacity may determine the clinical outcome of stroke patients i.e. severely disabled, moderately disabled or no signs at all. This study will assess these parameters in elderly stroke patients compared to their age-matched stroke-free counterparts and healthy young volunteers.

Condition or disease
Stroke

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Endothelial Progenitor Cells: Potential Biomarkers for Diagnosis and Prognosis of Ischaemic Stroke
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : January 2020

Group/Cohort
Lacunar stroke
Blood samples will be taken from 50 patients who have been diagnosed to have lacunar stroke and are 65 years of age or above.
Cortical stroke
Blood samples will be taken from 50 patients who have been diagnosed to have cortical stroke and are 65 years of age or above.
Elderly healthy volunteers
Blood samples will be taken from 50 healthy individuals who are 65 years of age or above.
Young healthy volunteers
Blood samples will be taken from 50 healthy individuals who are between 18 and 64 years of age.



Primary Outcome Measures :
  1. Detection of disability or dependence in the daily activities [ Time Frame: On day 90 after stroke ]
    to be assessed by modified Rankin scale


Secondary Outcome Measures :
  1. Changes in circulating EPC numbers in elderly patients with lacunar or cortical stroke [ Time Frame: within the first 48 h of stroke and on days 7, 30 and 90 after stroke ]
    to be assessed by flow cytometry

  2. Changes in EPC functional capacity in elderly patients with lacunar or cortical stroke [ Time Frame: within the first 48 h of stroke and on days 7, 30 and 90 after stroke ]
    to be assessed by mobility, proliferation, colony forming unit and matrigel tube formation assays

  3. Changes in circulating EPC numbers in stroke patients vs healthy controls [ Time Frame: patients - within the first 48 h of stroke and on days 7, 30 and 90 after stroke vs controls - once ]
    to be assessed by flow cytometry

  4. Changes in EPC functional capacity in stroke patients vs healthy controls [ Time Frame: patients - within the first 48 h of stroke and on days 7, 30 and 90 after stroke vs controls - once ]
    to be assessed by mobility, proliferation, colony forming unit and matrigel tube formation assays


Other Outcome Measures:
  1. Changes in plasma VEGF levels between stroke patients and healthy controls [ Time Frame: within the first 48 h of stroke and on days 7, 30 and 90 after stroke vs controls - once ]
    VEGF levels will be reported as pg/ml.

  2. Changes in plasma inflammatory cytokine levels between stroke patients and healthy controls [ Time Frame: within the first 48 h of stroke and on days 7, 30 and 90 after stroke vs controls - once ]
    Levels of all cytokines (TNF-alpha, TGF-beta, MCP-1) will be reported as pg/ml.

  3. Changes in EPC eNOS activity between stroke patients and healthy controls [ Time Frame: within the first 48 h of stroke and on days 7, 30 and 90 after stroke vs controls - once ]
    eNOS activity in EPC homogenates will be reported as mU/mg protein.


Biospecimen Retention:   Samples Without DNA
plasma


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients admitted to Nottingham University Hospitals Stroke Service will be recruited for the study. Similar age patients' relatives, friends or carers will be recruited as age-matched healthy volunteers. Staff and students working at the Clinical Sciences Building (where the study will be performed) will be recruited as young healthy volunteers.
Criteria

Inclusion Criteria:

  • Participants with Stroke:

Patients with anterior circulation IS and aged 65 years or older. Independence prior to stroke (mRS<3). Ability to give informed consent (directly or via consultee).

  • Age Matched Controls (Healthy Volunteers) Individuals aged 65 years or above. No previous history of stroke. Ability to give consent to take part in the study.
  • Young Healthy Volunteers Individuals aged between 18 to 64 years of age. No previous history of stroke. Ability to give consent to take part in the study.

Exclusion Criteria:

  • Participants with Stroke:

Patients with posterior circulation IS and aged below 65 years of age. Patients with recent recurrent IS. Patients with transient ischaemic attack or IS within the last 3 months. Patients with primary intracerebral haemorrhage.

  • Age Matched Controls (Healthy Volunteers) Individuals aged below 65 years of age. Previous history of stroke.
  • Young Healthy Volunteers (18-64):

Individuals aged below 18 years or are 65 years of age or above. Previous history of stroke.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02980354


Contacts
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Contact: Ulvi Bayraktutan, PhD +44 115 8231764 ulvi.bayraktutan@nottingham.ac.uk
Contact: Nikola Sprigg, MD +44 115 8231778 nikola.sprigg@nottingham.ac.uk

Locations
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United Kingdom
Clinical Sciences Building, University of Nottingham Recruiting
Nottingham, United Kingdom, NG5 1PB
Contact: Ulvi Bayraktutan, PhD    +44 115 8231764    ulvi.bayraktutan@nottingham.ac.uk   
Nottingham University Hospitals NHS Trust Recruiting
Nottingham, United Kingdom, NG5 1PB
Contact: Nikola Sprigg, MD    +44 115 8231778    nikola.sprigg@nottingham.ac.uk   
Contact: Amanda Buck    +44 115 8231772    amanda.buck@nottingham.ac.uk   
Sponsors and Collaborators
University of Nottingham
The Dunhill Medical Trust
Investigators
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Principal Investigator: Ulvi Bayraktutan, PhD University of Nottingham

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Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT02980354     History of Changes
Other Study ID Numbers: 16057
First Posted: December 2, 2016    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified IPD will be made available to other researchers after publication of the research findings. De-identified IPD underlying the results presented in these articles including tables, figures or supplementary material, will be shared as per the regulations of the University of Nottingham indicated on https://www.nottingham.ac.uk/fabs/rgs/research-data-management/data-sharing-and-archiving/sharing-data.aspx.
Time Frame: Data will be shared 12 months after the publication of all relevant research findings.
Access Criteria: All requests regarding the data share should be directed to the chief investigator by email.
URL: https://www.nottingham.ac.uk/fabs/rgs/research-data-management/data-sharing-and-archiving/sharing-data.aspx
Keywords provided by University of Nottingham:
endothelial progenitor cells, ischaemic stroke, aging
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases