Endothelial Function and Arterial StiffnessNCT02745665
A Pilot Case Control Study of Vascular Function in Cyclists
An observational study of Endothelial Function and Arterial Stiffness, run by St George's, University of London at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Endothelial Function and Arterial Stiffness
- What is being tested?
- flow mediated dilation (endothelial function), ABPI and Pulse wave velocity and augmentation index
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Jan 2017to Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
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)
Who may be able to join
- Males + 18 years elite or amateur racing cyclists with more than 3 years of training
Who cannot join
- - 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
St George's University Hospitals NHS Foundation Trust
Tooting, London, SW17 0QT
Rob Hinchliffe
About this study
Official title: A Pilot Case Control Study of Endothelial Function and Arterial Stiffness in Male Cyclists and Healthy Subjects
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).
Read the 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.
- Being tested
- flow mediated dilation (endothelial function), ABPI, Pulse wave velocity and augmentation index, blood pressure, ramp test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flow mediated dilation (endothelial function)Other
Also called vascular function assessment
ABPIOther
Also called Duplex ultrasound and ankle brachial pressure index
Pulse wave velocity and augmentation indexOther
Also called Arterial stiffness
blood pressureOther
ramp testOther
Also called 20 minute static cycle ride to exhaustion
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Other: flow mediated dilation (endothelial function); Other: ABPI; Other: Pulse wave velocity and augmentation index; Other: blood pressure; Other: ramp test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
pulse wave velocity
is the gold standard o assess arterial stiffness using the non invasive system of Complior (Arthec Medical)
Measured: 6 months
Secondary outcomes (1)
augmentation index
measurement to assess arterial stiffness using the non invasive system of Complior (Arthec Medical)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study start10 Jan 2017
- Primary completionJun 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endothelial Function and Arterial StiffnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St George's, University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rob Hinchliffe, Principal investigator, St George's, University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02745665
- Sponsor's protocol ID
- 16.0065
- Status last verified
- Jan 2018
- First submitted
- 6 Apr 2016
- Last updated
- 11 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 22186674
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Case Control Study of Endothelial Function and Arterial Stiffness in Male Cyclists and Healthy Subjects
- ClinicalTrials.gov ID
- NCT02745665
- Acronym / sponsor ID
- 16.0065
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- St George's, University of LondonUniversity, hospital or other
- Study start
- 10 Jan 2017 (actual)
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 20 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1-Elite Cyclist | – | Other: flow mediated dilation (endothelial function), Other: ABPI, Other: Pulse wave velocity and augmentation index, Other: blood pressure, Other: ramp test10 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 |
| 2-Amateur Cyclist | – | Other: flow mediated dilation (endothelial function), Other: ABPI, Other: Pulse wave velocity and augmentation index, Other: blood pressure, Other: ramp test10 asymptomatic cyclists with no evidence of EF FLOW MEDIATED DILATION ABPI PULSE WAVE VELOCITY AND AUGMENTATION Blood pressure RAMP Test |
| 3-Control | – | Other: flow mediated dilation (endothelial function), Other: ABPI, Other: Pulse wave velocity and augmentation index, Other: blood pressure, Other: ramp test10 age-matched healthy male group FLOW MEDIATED DILATION ABPI PULSE WAVE VELOCITY AND AUGMENTATION Blood pressure RAMP Test |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (1 listed)
- Males + 18 years elite or amateur racing cyclists with more than 3 years of training
Key exclusion criteria (8 listed)
- - 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| flow mediated dilation (endothelial function)Also: vascular function assessment | Other | 1-Elite Cyclist, 2-Amateur Cyclist, 3-Control |
| ABPIAlso: Duplex ultrasound and ankle brachial pressure index | Other | 1-Elite Cyclist, 2-Amateur Cyclist, 3-Control |
| Pulse wave velocity and augmentation indexAlso: Arterial stiffness | Other | 1-Elite Cyclist, 2-Amateur Cyclist, 3-Control |
| blood pressure | Other | 1-Elite Cyclist, 2-Amateur Cyclist, 3-Control |
| ramp testAlso: 20 minute static cycle ride to exhaustion | Other | 1-Elite Cyclist, 2-Amateur Cyclist, 3-Control |
Primary outcome
Flow Mediated Dilatation
Time frame: 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
Time frame: 6 months
is the gold standard o assess arterial stiffness using the non invasive system of Complior (Arthec Medical)
1 secondary outcome
augmentation index
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2018.
- Background: PubMed 22186674Peach 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rob Hinchliffe principal investigator
St George's, University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endothelial Function and Arterial Stiffness, run by St George's, University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cristiana Vitale, Md, PhD (07702288177, cristinan.vitale@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flow Mediated Dilatation (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02745665, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2018.