Bayraktutan Dunhill Medical Trust EPC Study

NCT02980354 | Unknown DMC

• 1 other identifier: 16057
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Stroke

Keywords

endothelial progenitor cells, ischaemic stroke, aging

Outcome Measures

Primary Outcomes (1)

• Detection of disability or dependence in the daily activities

  to be assessed by modified Rankin scale

  On day 90 after stroke

Secondary Outcomes (4)

• Changes in circulating EPC numbers in elderly patients with lacunar or cortical stroke

  within the first 48 h of stroke and on days 7, 30 and 90 after stroke

• Changes in EPC functional capacity in elderly patients with lacunar or cortical stroke

  within the first 48 h of stroke and on days 7, 30 and 90 after stroke

• Changes in circulating EPC numbers in stroke patients vs healthy controls

  patients - within the first 48 h of stroke and on days 7, 30 and 90 after stroke vs controls - once

• Changes in EPC functional capacity in stroke patients vs healthy controls

  patients - within the first 48 h of stroke and on days 7, 30 and 90 after stroke vs controls - once

Other Outcomes (3)

• Changes in plasma VEGF levels between stroke patients and healthy controls

  within the first 48 h of stroke and on days 7, 30 and 90 after stroke vs controls - once

• Changes in plasma inflammatory cytokine levels between stroke patients and healthy controls

  within the first 48 h of stroke and on days 7, 30 and 90 after stroke vs controls - once

• Changes in EPC eNOS activity between stroke patients and healthy controls

  within the first 48 h of stroke and on days 7, 30 and 90 after stroke vs controls - once

Study Arms (4)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nottingham: lead
• The Dunhill Medical Trust: collaborator

Study Sites (2)

Clinical Sciences Building, University of Nottingham

Nottingham, NG5 1PB, United Kingdom

RECRUITING

Nottingham University Hospitals NHS Trust

Nottingham, NG5 1PB, United Kingdom

RECRUITING

Related Publications (4)

• Kadir RRA, Alwjwaj M, Rakkar K, Othman OA, Sprigg N, Bath PM, Bayraktutan U. Outgrowth Endothelial Cell Conditioned Medium Negates TNF-alpha-Evoked Cerebral Barrier Damage: A Reverse Translational Research to Explore Mechanisms. Stem Cell Rev Rep. 2023 Feb;19(2):503-515. doi: 10.1007/s12015-022-10439-4. Epub 2022 Sep 2.

  PMID: 36056287 DERIVED

• Reskiawan A Kadir R, Alwjwaj M, Ahmad Othman O, Rakkar K, Sprigg N, Bath PM, Bayraktutan U. Inhibition of oxidative stress delays senescence and augments functional capacity of endothelial progenitor cells. Brain Res. 2022 Jul 15;1787:147925. doi: 10.1016/j.brainres.2022.147925. Epub 2022 Apr 22.

  PMID: 35469846 DERIVED

• Rakkar K, Othman O, Sprigg N, Bath P, Bayraktutan U. Endothelial progenitor cells, potential biomarkers for diagnosis and prognosis of ischemic stroke: protocol for an observational case-control study. Neural Regen Res. 2020 Jul;15(7):1300-1307. doi: 10.4103/1673-5374.269028.

  PMID: 31960816 DERIVED

• Bayraktutan U. Endothelial progenitor cells: Potential novel therapeutics for ischaemic stroke. Pharmacol Res. 2019 Jun;144:181-191. doi: 10.1016/j.phrs.2019.04.017. Epub 2019 Apr 17.

  PMID: 31004788 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Ulvi Bayraktutan, PhD

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ulvi Bayraktutan, PhD

CONTACT

+44 115 8231764; ulvi.bayraktutan@nottingham.ac.uk

Nikola Sprigg, MD

CONTACT

+44 115 8231778; nikola.sprigg@nottingham.ac.uk

Study Design

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

Study Record Dates

• First Submitted: November 15, 2016
• First Posted: December 2, 2016
• Study Start: February 1, 2017
• Primary Completion: November 1, 2019
• Study Completion: January 1, 2020
• Last Updated: May 3, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share
• 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.

Locations

GB (2)