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

NCT ID: NCT04122794

Last Updated: 2024-04-12

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 13 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-11-20
• Study Completion Date: 2024-03-22

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.

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.

Conditions

Vascular Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Limerick

OTHER

Sponsor Role: collaborator

University Hospital of Limerick

OTHER

Sponsor Role: lead

Responsible Party

Fiona Leahy

Professor Eamon Kavanagh Prinicipal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eamon Kavanagh, MD FRCSI

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Limerick

Locations

University Hospital Limerick

Limerick, , Ireland

Countries

Ireland

Other Identifiers

DVS006

Identifier Type: -

Identifier Source: org_study_id