A Pilot Case Control Study of Vascular Function in Cyclists

NCT02745665 | Unknown

• 1 other identifier: 16.0065
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Endothelial Function and Arterial Stiffness

Outcome Measures

Primary Outcomes (2)

• 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

• pulse wave velocity

  is the gold standard o assess arterial stiffness using the non invasive system of Complior (Arthec Medical)

  6 months

Secondary Outcomes (1)

• augmentation index

  6 months

Study Arms (3)

1-Elite Cyclist

10 symptomatic cyclists with unilateral diagnosis of iliac EF, FLOW MEDIATED DILATION Ankle brachial pressure index (ABPI) PULSE WAVE VELOCITY AND AUGMENTATION INDEX Blood pressure RAMP Test

Other: flow mediated dilation (endothelial function); Other: ABPI; Other: Pulse wave velocity and augmentation index; Other: blood pressure; Other: ramp test

2-Amateur Cyclist

10 asymptomatic cyclists with no evidence of EF FLOW MEDIATED DILATION ABPI PULSE WAVE VELOCITY AND AUGMENTATION Blood pressure RAMP Test

Other: flow mediated dilation (endothelial function); Other: ABPI; Other: Pulse wave velocity and augmentation index; Other: blood pressure; Other: ramp test

3-Control

10 age-matched healthy male group FLOW MEDIATED DILATION ABPI PULSE WAVE VELOCITY AND AUGMENTATION Blood pressure RAMP Test

Other: flow mediated dilation (endothelial function); Other: ABPI; Other: Pulse wave velocity and augmentation index; Other: blood pressure; Other: ramp test

Interventions

flow mediated dilation (endothelial function) OTHER

Also known as: vascular function assessment

1-Elite Cyclist; 2-Amateur Cyclist; 3-Control

ABPI OTHER

Also known as: Duplex ultrasound and ankle brachial pressure index

1-Elite Cyclist; 2-Amateur Cyclist; 3-Control

Pulse wave velocity and augmentation index OTHER

Also known as: Arterial stiffness

1-Elite Cyclist; 2-Amateur Cyclist; 3-Control

blood pressure OTHER

1-Elite Cyclist; 2-Amateur Cyclist; 3-Control

ramp test OTHER

Also known as: 20 minute static cycle ride to exhaustion

1-Elite Cyclist; 2-Amateur Cyclist; 3-Control

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Elite Cyclists with diagnosis of unilateral iliac EF - symptomatic Amateur racing cyclists with at least 3 years training asymptomatic Healthy males (age matched)

You may qualify if:

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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• St George's, University of London: lead

Study Sites (1)

St George's University Hospitals NHS Foundation Trust

Tooting, London, SW17 0QT, United Kingdom

RECRUITING

Related 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.

  PMID: 22186674 BACKGROUND

MeSH Terms

Interventions

Vascular Stiffness; Blood Pressure

Intervention Hierarchy (Ancestors)

Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Hemodynamics

Study Officials

• Rob Hinchliffe

  St George's, University of London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cristiana Vitale, Md, PhD

CONTACT

07702288177; cristinan.vitale@gmail.com

Fabrizio D'Abate, MSc

CONTACT

07730441382; fabrizio.d'abate@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2016
• First Posted: April 20, 2016
• Study Start: January 10, 2017
• Primary Completion: June 1, 2018
• Study Completion: September 1, 2018
• Last Updated: January 11, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)