A Pilot Case Control Study of Vascular Function in Cyclists

• Conditions: Endothelial Function and Arterial Stiffness

• Registration Number: NCT02745665
• Lead Sponsor: St George's, University of London

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 elite/amateur 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 and/or 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 criteria/tools 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 Timeline

• Study First Submitted: 2016-04-06
• Study First Submitted QC: 2016-04-15
• Study First Posted: 2016-04-20
• Study Start: 2017-01-10
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-10
• Last Update Posted: 2018-01-11
• Primary Completion: 2018-06
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

• Males + 18 years elite or amateur racing cyclists with more than 3 years of training

Exclusion Criteria

• • Subjects with a previous history of acute coronary syndrome (including myocardial infarction), stroke, transient ischaemic attack, cardiac surgery, other major cardiovascular (CV) surgery, or percutaneous coronary intervention (PCI), carotid surgery or carotid angioplasty, valvular heart, dysrhythmia
• subjects treated with cardiovascular medication for blood pressure, or cholesterol
• subjects with any clinical condition (diabetes, dyslipidaemia, obesity) that in the opinion of the investigator, may have a possible unfavourable effect on patient risk if included in the study, or is likely to interfere with the requirements of the study
• subject with characteristics that may interfere with adherence to the study protocol, such as dementia, substance abuse, history of non-compliance with prescribed medications, or medical appointment
• subject participating in another trial of an investigational drug or device within 30 days prior to screening will be excluded.
• subject that previously underwent surgery for iliac EF
• female subjects
• smokers

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Flow Mediated Dilatation	6 months	is the gold standard to measure endothelial function with a High Definition Imaging 3000 ultrasound system (ATL, Bothell, WA, USA) equipped with a 12.5 MHz linear array transducer
pulse wave velocity	6 months	is the gold standard o assess arterial stiffness using the non invasive system of Complior (Arthec Medical)

Secondary Outcome Measures

Name	Time	Method
augmentation index	6 months	measurement to assess arterial stiffness using the non invasive system of Complior (Arthec Medical)

Trial Locations

Locations (1)

St George's University Hospitals NHS Foundation Trust; 🇬🇧 Tooting, London, United Kingdom