The Role of Unsteady Wall Shears Stress Stimuli on Human... | NCT04122794

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

NCT04122794

Sponsor

University Hospital of Limerick

Status

Terminated

Last Update Posted

Apr 12, 2024Actual

Enrollment

13Actual

Phase

Not provided

Conditions

Vascular Diseases

Interventions

Not provided

Countries

Ireland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Impact of Covid-19 and staffing has required us to suspend this study

Expanded Access Info

Start Date

Nov 20, 2019Actual

Primary Completion Date

Mar 22, 2023Actual

Completion Date

Mar 22, 2024Actual

First Submitted Date

Oct 9, 2019

First Submission Date that Met QC Criteria

Oct 9, 2019

First Posted Date

Oct 10, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 11, 2024

Last Update Posted Date

Apr 12, 2024Actual

Name	Class
University of Limerick	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

13Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Women attending Maternity Services in Limerick who are pregnant and due for routine delivery that meet all the inclusion and exclusion criteria.

Sampling Method

Probability Sample

Name	Affiliation	Role
Eamon Kavanagh, MD FRCSI	University Hospital of Limerick	Principal Investigator

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided