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STUDY PROTOCOL
Year : 2018  |  Volume : 3  |  Issue : 3  |  Page : 101-105

High focused Evaluation of Atherosclerotic risk profile in Retinal Thrombosis: Vascular events Incidence, Sex involvement and Interventional outcomes assessed by Ophthalmologists and internists Network – HEART VISION study protocol


1 Department of Internal Medicine and Medical Specialties and Research Center on Gender and Evaluation and Promotion of Quality in Medicine (CEQUAM), Sapienza-University of Rome, Rome, Italy
2 Department of Sense Organs, Sapienza-University of Rome, Rome, Italy
3 Department of Computer, Control, and Management Engineering Antonio Ruberti, Sapienza-University of Rome, Rome, Italy
4 Centre for Outcomes Research and Evaluation (CORE) McGill University Health Centre Research Institute, Montreal, Canada; Department of Experimental Medicine, Sapienza-University of Rome, Rome, Italy

Correspondence Address:
Marco Proietti
IRCCS Istituto di Ricerche Farmacologiche “Mario Negri”, Milan
Italy
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Source of Support: This study was funded by Sapienza-University of Rome in 2014 -C26A147HC8., Conflict of Interest: None


DOI: 10.4103/2542-3975.235145

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Background and objectives: Retinal vein occlusion (RVO), one of the most relevant causes of vision loss, still represents an open issue in ophthalmology and vascular medicine. Its epidemiology and management approach have not been clearly characterized yet, with several grey zones requiring investigation. Significance of RVO on cardiovascular prognosis is also unclear. “High focused Evaluation of Atherosclerotic risk profile in Retinal Thrombosis: Vascular events Incidence, Sex involvement and Interventional outcomes assessed by Ophthalmologists and internists Network” (HEART VISION) is a longitudinal, prospective, multi-center study which aims at determining the epidemiology, potentially modifiable risk factors and the determinants of RVO in an Italian-based cohort. Methods: Enrollment of all the eligible patients presenting to recruiting centers (i.e. ophthalmology emergency room and thrombosis centers) with suspect of RVO. At baseline, all patients will undergo an opthalmologic evaluation and further investigations about cardiovascular co-morbidities and risk factors. Recruited patients will be followed for a 2-year period. Outcome measures: Data about adverse cardiovascular events and eye-related outcomes will be recorded. Discussion: HEART VISION will present data on prevalence and will inform on the prognosis of RVO in an Italian-based cohort. Characterization and prospective evaluation of these patients will be useful in developing novel strategies for management of RVO and their cardiovascular-related risk factors. Ethics and dissemination: This study protocol (n. 1.0, 01.07.2014) was approved by the Sapienza-University of Rome, Ethics Board (Protocol No. 1076/14). This study will be performed in accordance with the Declaration of Helsinki. Dissemination plans include presentations at scientific conferences and publication in scientific journals. Trial registration: ClinicalTrials.gov Identifier: NCT02257333 on October 6, 2014.


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