External Iliac Artery Endofibrosis in Cycling

N/AActive Not RecruitingNCT07194330

Jesus Torres1 enrolled

Overview

A data request will be made regarding the tests conducted by the subject related to their performance, as well as the results of the medical diagnostic tests performed. The requested data/variables pertain to physical performance: power output on the pedals during training sessions, tests, and competitions, as well as medical tests during the diagnostic process.

The medical tests include those performed during the diagnostic process of the pathophysiology of external iliac artery endofibrosis: imaging tests (Doppler ultrasound), exercise stress tests, computed tomography (CT) imaging, and intravascular ultrasound (IVUS). Data collection will be carried out prior to analysis and processing of the results; all data will be anonymized.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Iliac Artery Occlusive Disease Blood Flow Velocity Performance Cycling

Interventions

None-placeboDIAGNOSTIC_TEST

Not be displayed, only retrospective data will be required

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: Clinical diagnosis of external iliac artery endofibrosis confirmed by medical imaging (e.g., Doppler ultrasound, CT scan, or IVUS). Age between 18 and 65 years. Must be a regular cyclist (at least 500 training sessions per year for the past 5 years). Ability to complete physical performance tests (e.g., cycling power output measurements, Lactate Threshold test). No prior surgical intervention for external iliac artery endofibrosis or other lower extremity diseases Willingness to provide informed consent and participate in the study. Exclusion Criteria: History of major cardiovascular disease (e.g., heart attack, stroke). Pregnancy or breastfeeding. Use of medications that significantly affect vascular health (e.g., anticoagulants, steroids). Uncontrolled diabetes or other chronic metabolic disorders. Recent lower extremity surgery (within the last 6 months). Any condition that could interfere with the performance tests (e.g., neurological disorders, severe joint pain). Diagnosis of other vascular diseases (e.g., deep vein thrombosis, atherosclerosis) that could affect arterial function. History of systemic or local infections that may impact the vascular system. History of significant trauma or injury to the lower extremities (e.g., fractures, ligament tears). Any condition preventing safe participation in physical tests, including severe cardiovascular or musculoskeletal limitations.

Locations (1)

C San Bartolome 4

Estella-Lizarra, Navarre, Spain

Outcomes

Primary Outcomes

Eco-Doppler with colour

The results of distal systolic flow at rest and after a performance claudication test will be assessed. These will be measured using imaging to provide qualitative control of the results, as well as by evaluating the peak systolic flow velocity in the external iliac artery in centimeters per second (cm/s).

Time frame: 12 months pre-intervention/procedure/surgery; 12 months post-intervention/procedure/surgery.

Performance data in training and competition

Data of power applied on pedals´powermeter will be collected, data will be from 2022 to 2025 training and competitive seasons, it will be collected as power in watts applied by cyclist during pedal stroke, conidered as external load. External load developed by participant during trainings and competitions will be collected in raw format, as watts applied by participant meassured by his powermeter installed in his bicycle second by second.

Time frame: 3 years "pre" and 2 years "post intervention/surgery", and during study completion, a total of 5 years of time frame

Distal systolic and dyastolic pressure

Distal systolic and diastolic pressure will be assessed before and after a specific claudication test, and it will be recorded in millimeters of mercury (mmHg).

Time frame: 12 months pre-intervention/procedure/surgery; 12 months post-intervention/procedure/surgery.

Angiography

The angiography test will be carried out using computed tomography and intravascular ultrasound examinations via catheterization. Imaging results from angiography will be collected, the thickness of the arterial wall will be measured in millimeters, and a qualitative structural assessment of the imaging will be performed."

Time frame: 12 months pre-intervention/procedure/surgery

Outcomes during surgery

During the surgery, the results obtained from the procedure, as well as the applied technique, will be presented, potentially in the form of images or explanatory diagrams of the process.

Data from ClinicalTrials.gov

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