A Pilot Case Control Study of Vascular Function in Cyclists

Endothelial Function and Arterial Stiffness Clinical Trial

Official title:

A Pilot Case Control Study of Endothelial Function and Arterial Stiffness in Male Cyclists and Healthy Subjects

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02745665
• Other study ID #: 16.0065
• Status: Recruiting
• Phase: N/A
• First received: April 6, 2016
• Last updated: January 10, 2018
• Start date: January 10, 2017
• Est. completion date: September 2018

Study information

• Verified date: January 2018
• Source: St George's, University of London
• Contact: Cristiana Vitale, Md, PhD
• Phone: 07702288177
• Email: cristinan.vitale[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endothelial Function and Arterial Stiffness

Intervention

Other:
• flow mediated dilation (endothelial function)

• ABPI

• Pulse wave velocity and augmentation index

• blood pressure

• ramp test

Locations

Country	Name	City	State
United Kingdom	St George's University Hospitals NHS Foundation Trust	Tooting	London

Sponsors (1)

Lead Sponsor	Collaborator
St George's, University of London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Peach G, Schep G, Palfreeman R, Beard JD, Thompson MM, Hinchliffe RJ. Endofibrosis and kinking of the iliac arteries in athletes: a systematic review. Eur J Vasc Endovasc Surg. 2012 Feb;43(2):208-17. doi: 10.1016/j.ejvs.2011.11.019. Epub 2011 Dec 19. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flow Mediated Dilatation	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	6 months
Primary	pulse wave velocity	is the gold standard o assess arterial stiffness using the non invasive system of Complior (Arthec Medical)	6 months
Secondary	augmentation index	measurement to assess arterial stiffness using the non invasive system of Complior (Arthec Medical)	6 months