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The Role of Unsteady Wall Shears Stress Stimuli on Human Umbilical Vein Endothelial Cells Harvested From Umbilical Cords (HUVEC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04122794
Recruitment Status : Recruiting
First Posted : October 10, 2019
Last Update Posted : October 10, 2019
Sponsor:
Collaborator:
University of Limerick
Information provided by (Responsible Party):
Fiona Leahy, University Hospital of Limerick

Brief Summary:
The aim of this study is to obtain and test endothelial cells (EC's) from umbilical cords to examine specific properties of these cells which make up the inner lining of blood vessels.

Condition or disease
Vascular Diseases

Detailed Description:

Mechanical testing will be performed on the Ec's to see how the cells reacts and ultimately how the blood vessel is affected.

A central role in the mechanism that defines the nature of vessel remodelling is played by endothelial cells. EC's are extremely sensitive to the frictional forces exerted on a unit of the endothelial area by blood flow. This mechanical stimulus is known as wall shear stress (WSS). WSS experienced by EC's in-vivo is unsteady due to the unsteady nature of blood flow produced during the cardiac cycle and due to the complex nature of the vascular tree.

The extent to which this applies to venous cells and tissue remains unknown and it is the focus of this study.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: The Role of Unsteady Wall Shears Stress Stimuli on Human Umbilical Vein Endothelial Cells (HUVECs) Harvested From Umbilical Cords
Estimated Study Start Date : October 14, 2019
Estimated Primary Completion Date : October 14, 2020
Estimated Study Completion Date : October 14, 2021



Primary Outcome Measures :
  1. The identification of Endothelial Cell phenotype [ Time Frame: 2 years ]
    To identify this phenotype by assessing the endothelial identity markers, the endothelial to mesenchymal transition markers and the regulation of genes involved in EC quiescence.


Biospecimen Retention:   Samples Without DNA
Endothelial cells will be retrieved from the endothelial vein of human umbilical cord tissue that would be otherwise discarded.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Probability Sample
Study Population
Women attending Maternity Services in Limerick who are pregnant and due for routine delivery that meet all the inclusion and exclusion criteria.
Criteria

Inclusion Criteria:

  • Patients who are attending the Maternity Services who are pregnant and due for routine delivery.
  • Aged 18- 40 years.
  • Are willing and capable to voluntarily sign a statement of informed consent to take part in this investigation.
  • Patients due to give birth to twins will be included in this study. Women having both "normal" delivery and caesarean section delivery will be included in this study.

Exclusion Criteria:

  • Patients unable to provide informed consent.
  • Patients who are under the age of 18 and over the age of 40 years.
  • Patients who are deemed unsuitable due to any circumstances as deemed appropriate by the Consultant.
  • Patients with a Blood Borne Virus (HIV Type 1, HIV Type 2, Hepatitis B, Hepatitis C) will be excluded from the study.
  • Patients with diabetes that is not gestational in nature will be excluded from this study.
  • Patients due to deliver triplets or more will be excluded from this study.
  • Patients who deliver their baby before 37 weeks gestation will not have umbilical cord tissue retained for study purposes.

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): NCT04122794


Contacts
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Contact: Fiona Leahy, CNM Research 061588394 fionac.leahy@hse.ie

Locations
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Ireland
University Hospital Limerick Recruiting
Limerick, Ireland
Sponsors and Collaborators
University Hospital of Limerick
University of Limerick
Investigators
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Principal Investigator: Eamon Kavanagh, MD FRCSI University Hospital of Limerick

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Responsible Party: Fiona Leahy, Professor Eamon Kavanagh Prinicipal Investigator, University Hospital of Limerick
ClinicalTrials.gov Identifier: NCT04122794    
Other Study ID Numbers: CRSU020
First Posted: October 10, 2019    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fiona Leahy, University Hospital of Limerick:
Endothelial Cells
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases