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

NCT04122794 | Terminated

• 1 other identifier: DVS006
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Vascular Diseases

Keywords

Endothelial Cells

Outcome Measures

Primary Outcomes (1)

• The identification of Endothelial Cell phenotype

  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.

  2 years

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital of Limerick: lead
• University of Limerick: collaborator

Study Sites (1)

University Hospital Limerick

Limerick, Ireland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Endothelial cells will be retrieved from the endothelial vein of human umbilical cord tissue that would be otherwise discarded.

MeSH Terms

Conditions

Vascular Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Eamon Kavanagh, MD FRCSI

  University Hospital of Limerick

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Eamon Kavanagh Prinicipal Investigator

Study Record Dates

• First Submitted: October 9, 2019
• First Posted: October 10, 2019
• Study Start: November 20, 2019
• Primary Completion: March 22, 2023
• Study Completion: March 22, 2024
• Last Updated: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)