Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06626659
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-02
Brief Title:
Lipoprotein a and Vascular Regenerative Cell Content
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Lipoprotein a and Vascular Regenerative Cell Content
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Lpa-VRCE
Brief Summary:
Lpa-VRCE is an observational cross sectional study looking at vessel reparative stem cell content in people with and without elevated lipoprotein a Lpa Specifically the type and number of these cells in peripheral blood samples will be measured in participants with Lpa 100 nmolL and compared to participants with Lpa 100 nmolL Determining the presence or absence of specific cells with blood vessel repair capacity in participants with high Lpa will further our knowledge of potential mechanisms through which Lpa influences cardiovascular health
Detailed Description:
Lipoprotein a Lpa is an independent genetically determined causal risk factor for the development of atherosclerotic cardiovascular disease It is estimated that 20-30 of the global population have elevated Lpa and recent multinational guideline endorsements strongly advise the routine measuring of Lpa at least once in a persons life Current Lpa risk level thresholds are described as 75 nmolL for low risk and 125 nmolL for high risk individuals Despite ongoing clinical trials there exists no approved therapeutic medication to specifically lower Lpa
Vascular regenerative cell exhaustion VRCE is described as the depletion of circulating pro-vascular reparative cells responsible for angiogenesis vasculogenesis and arteriogenesis Evidence in recent years has implicated VRCE as a novel mechanistic factor contributing to the aberrant cardiometabolic state present in type 2 diabetes obesity and in people of South Asian descent It has been demonstrated that the VRCE phenotype can be reversed by treatment with sodium glucose co-transporter 2 inhibitors or bariatric surgery
Lpa-VRCE is a cross-sectional observational two arm study enrolling 20 patients with elevated Lpa 100 nmolL and 20 patients with non-elevated Lpa 100 nmolL From peripheral blood mononuclear cells are isolated and enumerated via a multi-parametric flow cytometry assay utilizing aldehyde dehydrogenase activity and side scatter properties The hypothesis is that people with elevated Lpa have comparatively different progenitor cell phenotypes to people with normal Lpa levels
Vascular regenerative cell exhaustion VRCE is described as the depletion of circulating pro-vascular reparative cells responsible for angiogenesis vasculogenesis and arteriogenesis Evidence in recent years has implicated VRCE as a novel mechanistic factor contributing to the aberrant cardiometabolic state present in type 2 diabetes obesity and in people of South Asian descent It has been demonstrated that the VRCE phenotype can be reversed by treatment with sodium glucose co-transporter 2 inhibitors or bariatric surgery
Lpa-VRCE is a cross-sectional observational two arm study enrolling 20 patients with elevated Lpa 100 nmolL and 20 patients with non-elevated Lpa 100 nmolL From peripheral blood mononuclear cells are isolated and enumerated via a multi-parametric flow cytometry assay utilizing aldehyde dehydrogenase activity and side scatter properties The hypothesis is that people with elevated Lpa have comparatively different progenitor cell phenotypes to people with normal Lpa levels
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None