External Iliac Artery Endofibrosis: Performance-Related Suspicion, Diagnosis, Treatment, and Management in a Cyclist
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Eco-Doppler with colour
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Eco-Doppler with colour
时间窗: 12 months pre-intervention/procedure/surgery; 12 months post-intervention/procedure/surgery.
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).
Performance data in training and competition
时间窗: 3 years "pre" and 2 years "post intervention/surgery", and during study completion, a total of 5 years of time frame
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.
Distal systolic and dyastolic pressure
时间窗: 12 months pre-intervention/procedure/surgery; 12 months post-intervention/procedure/surgery.
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).
Angiography
时间窗: 12 months pre-intervention/procedure/surgery
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."
Outcomes during surgery
时间窗: Perioperative/Periprocedural
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.
Lactate thresholds test
时间窗: Through study completion, an average of 2 years".
The lactate threshold test will be performed to assess the power (watts) developed by the participant. Data collected during this test will be analyzed alongside other study variables to understand the relationships between performance metrics and the diagnosis of the condition described.
次要结局
未报告次要终点
研究者
Jesus Torres
Jesús Torres-Pérez: BsC, MD.
University of the Basque Country (UPV/EHU)