Study Results
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Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2020-03-01
2020-10-01
Brief Summary
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Detailed Description
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Most patients who suffer TOSs have an anatomical predisposition and sport activities of upper limbs may contribute to TOS onset. Disability and postintervention recovery related to TOS treatment and possible surgery can have a significant effect in the overall performance abilities of affected patients, and little has been published specifically about the risk of TOS athletes. Computational fluid dynamics (CFD) analysis is one of the key analysis methods used in bioengineering applications in studying the cardiovascular system. In this context a typical fluid dynamics analysis involves evaluation of basic fluid properties like flow velocity, and pressure, in relation to time and space.
This study aims to study CFD factors in thoracic outlet region (cervicothoracobrachial region) in order to evaluate the fluid - structure interactions between muscles, bones and vessels in this region in sporty subjects that participate in the following sports: baseball, tennis, swimming, rowing, volleyball, rugby football, weightlifting.
A cohort of healthy sporty subjects will be recruited and will undergo to diagnostic tests in order to assess the thoracic outlet region. For this reason, a Magnetic Resonance scan of the cervicothoracobrachial region and a duplex ultrasound of the upper limbs will be performed.
COMSOL Multiphysics ® cross-platform will be used for elements analysis, in the simulation study. The simulation will be implemented with FreeCAD 3d modeling in order to 3D geometry of studied elements.
The primary endpoint of this study is to calculate the risk of TOS onset in sporty subjects in order to prevent a disabling disease in this kind of subjects.
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Healthy sporty subjects
Healthy sporty subjects that participate in the following sports: baseball, tennis, swimming, rowing, volleyball, rugby football, weightlifting.
Magnetic Resonance Scan of Thoracic outlet region
Both groups will undergo Magnetic Resonance Scan of cervicothoracobrachial region in order to study the anatomy of this region.
Duplex Ultrasound assessment of Upper limbs
Both groups will undergo Duplex Ultrasound assessment of Upper limbs, in order to study diameters and flow of the vascular system of the upper limbs.
Healthy non-sporty subjects
Healthy subjects that do not partecipate in sport activities.
Magnetic Resonance Scan of Thoracic outlet region
Both groups will undergo Magnetic Resonance Scan of cervicothoracobrachial region in order to study the anatomy of this region.
Duplex Ultrasound assessment of Upper limbs
Both groups will undergo Duplex Ultrasound assessment of Upper limbs, in order to study diameters and flow of the vascular system of the upper limbs.
Interventions
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Magnetic Resonance Scan of Thoracic outlet region
Both groups will undergo Magnetic Resonance Scan of cervicothoracobrachial region in order to study the anatomy of this region.
Duplex Ultrasound assessment of Upper limbs
Both groups will undergo Duplex Ultrasound assessment of Upper limbs, in order to study diameters and flow of the vascular system of the upper limbs.
Eligibility Criteria
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Inclusion Criteria
sporty subjects that participate in the following sports: baseball, tennis, swimming, rowing, volleyball, rugby football, weightlifting
For "Non-Sporty" Group:
Subject not involved in sport activities
For both groups:
Exclusion Criteria
* presence of peripheral arterial disease,
* presence of malignant tumors,
* presence of serious cardiovascular and cerebrovascular pathologies,
* presence of renal and hepatic insufficiency
* subjects diagnosed with thoracic outlet syndrome or with symptoms related to the aforementioned syndrome.
18 Years
ALL
Yes
Sponsors
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University of Catanzaro
OTHER
Responsible Party
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Prof. Raffaele Serra, MD, Ph.D.
Associate Professor of Vascular Surgery
Principal Investigators
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Raffaele Serra, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University Magna Graecia of Catanzaro
Locations
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University Magna Graecia of Catanzaro
Catanzaro, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Chandra V, Little C, Lee JT. Thoracic outlet syndrome in high-performance athletes. J Vasc Surg. 2014 Oct;60(4):1012-7; discussion 1017-8. doi: 10.1016/j.jvs.2014.04.013. Epub 2014 May 14.
Duwayri YM, Emery VB, Driskill MR, Earley JA, Wright RW, Paletta GA Jr, Thompson RW. Positional compression of the axillary artery causing upper extremity thrombosis and embolism in the elite overhead throwing athlete. J Vasc Surg. 2011 May;53(5):1329-40. doi: 10.1016/j.jvs.2010.11.031. Epub 2011 Jan 26.
Melby SJ, Vedantham S, Narra VR, Paletta GA Jr, Khoo-Summers L, Driskill M, Thompson RW. Comprehensive surgical management of the competitive athlete with effort thrombosis of the subclavian vein (Paget-Schroetter syndrome). J Vasc Surg. 2008 Apr;47(4):809-820; discussion 821. doi: 10.1016/j.jvs.2007.10.057. Epub 2008 Feb 14.
Epidemiology, diagnosis and treatment of thoracic outlet syndrome: A systematic review. Acta Phlebol. 2015;16(2):59-68.
Other Identifiers
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ER.ALL.2018.17
Identifier Type: -
Identifier Source: org_study_id
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