Vascular DiseasesHUVECNCT04122794
The Role of Unsteady Wall Shears Stress Stimuli on Human Umbilical Vein Endothelial Cells Harvested From Umbilical Cords
An observational study of Vascular Diseases, run by University Hospital of Limerick at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Vascular Diseases
- How many people
- 13 participants
- Where
- 1 siteIreland
- Study dates
- 20 Nov 2019to 22 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Unsteady Wall Shears Stress Stimuli on Human Umbilical Vein Endothelial Cells (HUVECs) Harvested From Umbilical Cords
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.
Read the 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
- Keywords
- Endothelial Cells
- Medical subject headings
- Vascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start20 Nov 2019
- Primary completion22 Mar 2023
- Study completion22 Mar 2024
Why it stopped: Impact of Covid-19 and staffing has required us to suspend this study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Limerick
- Sponsor type
- University, hospital or other
- Collaborators
- University of Limerick
- Responsible party
- Principal investigator, Fiona Leahy, University Hospital of Limerick
- Investigators
- Eamon Kavanagh, MD FRCSI, Principal investigator, University Hospital of Limerick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04122794
- Sponsor's protocol ID
- DVS006
- Acronym
- HUVEC
- Status last verified
- Apr 2024
- First submitted
- 9 Oct 2019
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Unsteady Wall Shears Stress Stimuli on Human Umbilical Vein Endothelial Cells (HUVECs) Harvested From Umbilical Cords
- ClinicalTrials.gov ID
- NCT04122794
- Acronym / sponsor ID
- HUVEC / DVS006
- Conditions
- Vascular Diseases
- Keywords
- Endothelial Cells
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Impact of Covid-19 and staffing has required us to suspend this study
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University Hospital of LimerickUniversity, hospital or other
- Collaborators
- University of Limerick
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- 22 Mar 2023 (actual)
- Study completion
- 22 Mar 2024 (actual)
- First posted
- 10 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Age groups
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study was stopped early (reason given: Impact of Covid-19 and staffing has required us to suspend this study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eamon Kavanagh, MD FRCSI principal investigator
University Hospital of Limerick
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Diseases, run by University Hospital of Limerick at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Impact of Covid-19 and staffing has required us to suspend this study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The identification of Endothelial Cell phenotype (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.