Ignite Creation Date:
2024-05-06 @ 8:29 AM
Last Modification Date:
2024-10-26 @ 12:00 PM
Study NCT ID:
NCT02745665
Status:
UNKNOWN
Last Update Posted:
2018-01-11
First Post:
2016-04-06
Brief Title:
A Pilot Case Control Study of Vascular Function in Cyclists
Sponsor:
St Georges University of London
Organization:
St Georges University of London
Study Overview
Official Title:
A Pilot Case Control Study of Endothelial Function and Arterial Stiffness in Male Cyclists and Healthy Subjects
Status:
UNKNOWN
Status Verified Date:
2018-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a pilot study with the purpose of measuring vascular function assessed by evaluating arterial stiffness pulse wave velocity and augmentation index and endothelial function flow mediated dilatation in eliteamateur symptomatic male cyclists with unilateral Endofibrosis EF compared to asymptomatic males cyclists and to a group of age matched healthy males non-athletes
Detailed Description:
Endofibrosis EF of the iliac arteries is a non-atheromatous flow-limiting condition specific to highly trained athletes Although the pathophysiology is not well understood haemodynamic injury and mechanical stress are considered to play a key role in developing EF Recurrent exposure to these factors could trigger an arterial remodelling process that results in an intravascular lesion such as EF that more resembles an adaptive intimal thickening Although the natural history of this condition is not known it is believed to be progressive with increasing numbers of reports of limb threatening ischaemia due to dissection andor thrombosis of the arterial lumen Therefore it is imperative to understand the pathophysiological mechanism behind this condition in order to develop accurate diagnostic and screening criteriatools for an early identification and characterization of EF As there are no data in the literature supporting this hypothesis the investigators have designed this pilot study to evaluate this hypothesis as to whether athletes with EF have evidence of vascular dysfunction in their arteries There are currently no data on whether athletes who develop EF have underlying arterial disease or abnormalities It is quite possible that people who develop EF have an underlying systemic endothelial dysfunction and that this may represent a risk factor for the development of the disease Therefore the investigators will study non-invasively endothelial function measured as flow mediated dilatation as well as arterial stiffness measured as pulse wave velocity and augmentation index to improve the understanding about the structural and mechanical characteristics of the vascular tree in this cohort of patients
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