<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02257333</url>
  </required_header>
  <id_info>
    <org_study_id>HEART VISION</org_study_id>
    <nct_id>NCT02257333</nct_id>
  </id_info>
  <brief_title>Retinal Thrombosis and Atherosclerosis</brief_title>
  <acronym>HEART-VISION</acronym>
  <official_title>High Focused Evaluation of Atherosclerotic Risk Profile in Retinal Thrombosis: Vascular Events Incidence, Sex Involvement and Interventional Outcomes Assessed by Ophthalmologists and Internists Network</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Roma La Sapienza</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Florence</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Roma La Sapienza</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The retinal vein occlusion (RVO) is the second most common retinal disease after diabetic&#xD;
      retinopathy, and is a common cause of unilateral visual loss. The risk factors that&#xD;
      predispose to RVO are many and are generally the same as those found in vascular alterations&#xD;
      involving other parts of the body, as in the case of stroke or coronary heart disease.&#xD;
      Several authors have attempted to determine whether the pathogenesis of RVO can be of&#xD;
      arterial type, considering the disease as consequent to atherosclerosis, rather than&#xD;
      resulting from venous disease. Although less frequent than the other diseases RVO affects&#xD;
      considerably on health care costs. Direct medical costs showed that in one year a patient&#xD;
      with this disease has a higher than average cost for a patient with hypertension or glaucoma.&#xD;
      Knowing the prevalence of the disease in Italy and identify modifiable risk factors,&#xD;
      recognizing additional risk factors related to gender, genetic predisposition and especially&#xD;
      the social-economic and cultural background in the pathogenesis of RVO, are the objectives&#xD;
      that led to the planning of this study. In order to assess the prevalence of the disease and&#xD;
      the current &quot;clinical practice&quot; we aim to create an online register between Italian&#xD;
      specialist centers (ophthalmic emergency care and thrombosis centers) with immediate&#xD;
      portability and usability of the data.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The retinal vein occlusion (RVO) is the second most common retinal disease after diabetic&#xD;
      retinopathy, and is a common cause of unilateral visual loss. The occlusion of a branch of&#xD;
      the central retinal vein (BRVO) and central retinal vein occlusion (CRVO) are two topics&#xD;
      discussed and very deserving of further study, especially for the need of greater clarity&#xD;
      arising from the availability of new diagnostic and especially therapeutic opportunities.&#xD;
&#xD;
      The literature on the prevalence of RVO is not particularly rich, and the results of the&#xD;
      available studies are very heterogeneous because such studies are conducted on a few cases,&#xD;
      using different methodologies and are mainly characterized by a different distribution of&#xD;
      risk factors among the different populations. In this regard, it was particularly interesting&#xD;
      a publication of 2010 which proposed a combined analysis of the main study population&#xD;
      (population based study).&#xD;
&#xD;
      The sample of the final analysis was of 49 869 subjects, and the results showed that the&#xD;
      retinal vein occlusion overall prevalence, standardized for age and sex, is 5.2 per 1000, of&#xD;
      which 4.42 and 0.80 to BRVO and CRVO respectively. Despite the slightly higher prevalence in&#xD;
      females, this difference wasn't statistically significant.&#xD;
&#xD;
      In contrast, the prevalence of venous occlusion increases with increasing age in a&#xD;
      statistically significant manner, both in the overall analysis of the occlusions of branch&#xD;
      and central, that for the individual entities. This pattern is characteristic of chronic&#xD;
      degenerative diseases and in fact the RVO has a behavior very similar to that of these&#xD;
      diseases, probably because the risk factors (especially those such as atherosclerosis and&#xD;
      systemic hypertension) increases with age.&#xD;
&#xD;
      The results provided by these systematic analysis are particularly important because they&#xD;
      provide a reliable estimate of RVO prevalence in general population; must be considered,&#xD;
      however, the inherent limitations mainly concerning potential sources of heterogeneity, such&#xD;
      as different methodologies used, the fact that most of the studies were carried out on a&#xD;
      single ethnic group, often with different distribution of risk factors and therefore were not&#xD;
      suitable to capture these differences.&#xD;
&#xD;
      The risk factors predisposing to RVO are many and are generally the same as those found in&#xD;
      vascular alterations involving other parts of the body as in the case of stroke or coronary&#xD;
      heart disease. Several authors have attempted to determine whether the disease can be&#xD;
      consequent to atherosclerosis and therefore caused by arterial disease rather than the&#xD;
      pathogenesis of venous disease.&#xD;
&#xD;
      There is a very variable delay between the onset of symptoms and initiation of treatment; the&#xD;
      excessive delay of treatment was considered an exclusion criterion in only a minority of the&#xD;
      studies considered. Although it is very difficult to estimate the age of the thrombotic&#xD;
      event, early identification is surely preferable and the treatment time is a critical factor&#xD;
      to evaluate the efficacy of a therapeutic strategy. Because of the relatively small number of&#xD;
      patients is not possible to determine which therapy is more effective.&#xD;
&#xD;
      Recently new experimental therapeutic approaches have been proposed, such as intravitreal&#xD;
      administration of various drugs (steroids, anti-VEGF). It is not yet clear whether these&#xD;
      approaches can eliminate the need for anticoagulant therapy during the acute phase of the&#xD;
      disease. Surely antithrombotic drugs may have a role in the treatment of the acute phase of&#xD;
      the RVO, at least in some categories of patients, and can be used in association with&#xD;
      intravitreal drugs. Future studies should also explore the possibility of combined&#xD;
      approaches. The retinal vein occlusion is a disease related to age and surely there will be&#xD;
      an increase in social-economic impact of this disease due to the increase in population of&#xD;
      the most advanced age group.&#xD;
&#xD;
      To assess the social-economic impact should be considered in addition to visual impairment&#xD;
      related to the disease, the impact on quality of life of the patient and the direct medical&#xD;
      costs of retinal vein thrombosis have shown that in one year a patient with this disease has&#xD;
      an average cost 20% higher than a hypertensive patient (BRVO: + 16%; CRVO: + 22%) or glaucoma&#xD;
      ones (BRVO: + 18%; CRVO: + 24%); Therefore, although it is less frequent than the other&#xD;
      diseases RVO affects considerably on health care costs. The data available in the literature&#xD;
      show that in the overall one year management, direct costs that have the greatest impact, in&#xD;
      percentage terms, are the costs associated with ocular pathology caused by acute event&#xD;
      (thrombosis) and diagnostic tests. After three years, however, the cost is linked to systemic&#xD;
      disease (hospitalization) has a bigger impact in percentage terms, as if to indicate that&#xD;
      retinal vein thrombosis is nothing more than an epiphenomenon of systemic disease.&#xD;
&#xD;
      Operating Modes The study will be divided into 4 phases: Step 1: establishment of the&#xD;
      network: identification of specialized facilities (ophthalmic emergency care and thrombosis&#xD;
      centers), which may accept patients with suspected RVO, which will participate in the&#xD;
      establishment of the register online; Step 2: Create the registry and recruitment of patients&#xD;
      cohort; Step 3: Follow-up planned (1 month) for instrumental tests to confirm the diagnosis&#xD;
      of RVO; Step 4: Observational follow-up supported by dedicated web platform for the&#xD;
      identification of major adverse cardiovascular events, in order to export in the context of&#xD;
      clinical acquisitions epidemiological and disease management in real time.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 1, 2015</start_date>
  <completion_date type="Anticipated">September 2020</completion_date>
  <primary_completion_date type="Anticipated">September 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>2 Years</target_duration>
  <primary_outcome>
    <measure>Retinal Venous Occlusion Prevalence</measure>
    <time_frame>Baseline</time_frame>
    <description>The primary outcome result is about the description of RVO prevalence among the study population.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Atherosclerotic Risk Profile in RVO</measure>
    <time_frame>Baseline</time_frame>
    <description>The second primary outcome is to identify and describe the atherosclerotic burden and the atherosclerosis risk factors prevalence among RVO patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Acuity</measure>
    <time_frame>2 Years</time_frame>
    <description>To evaluate visual acuty in a long time frame after RVO. Visual acuity will be assessed according to Snellen and ETDRS scales.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major Adverse Cardiovascular Events</measure>
    <time_frame>2 Years</time_frame>
    <description>Evaluate incidence and prevalence of MACE among patients with RVO</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>RVO Recurrence</measure>
    <time_frame>2 Years</time_frame>
    <description>It will be evaluated wheter the first RVO episode could be a risk factor for the occurence of a new RVO.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Retinal Vein Occlusion</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Adult subjects with clinical suspicion of Retinal Venous Occlusion, consecutively enrolled&#xD;
        at specialized ophthalmologic centers afferent to the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical Suspicion of Retinal Vein Occlusion&#xD;
&#xD;
          -  Written Informed Consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Short Life Expectancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stefania Basili, MD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Roma La Sapienza</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Elena Pacella, MD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Roma La Sapienza</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Enzo M Vingolo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Roma La Sapienza</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Valeria Raparelli, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Roma La Sapienza</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Marco Proietti, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Roma La Sapienza</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Stefania Basili, MD</last_name>
    <phone>0649974678</phone>
    <phone_ext>+39</phone_ext>
    <email>stefania.basili@uniroma1.it</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Elena Pacella, MD</last_name>
    <email>elena.pacella@uniroma1.it</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Sapienza University of Rome - Policlinico Umberto I Roma</name>
      <address>
        <city>Rome</city>
        <state>I</state>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stefania Basili, MD</last_name>
      <phone>+390649974678</phone>
      <email>stefania.basili@uniroma1.it</email>
    </contact>
    <investigator>
      <last_name>Stefania Basili, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Elena Pacella, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Valeria Raparelli, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Marco Proietti, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Laura Napoleone, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Roberto Cangemi, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>September 26, 2014</study_first_submitted>
  <study_first_submitted_qc>October 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 6, 2014</study_first_posted>
  <last_update_submitted>December 11, 2018</last_update_submitted>
  <last_update_submitted_qc>December 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 13, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Roma La Sapienza</investigator_affiliation>
    <investigator_full_name>Stefania Basili</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Retinal Vein Occlusion</keyword>
  <keyword>Atherosclerosis</keyword>
  <keyword>Risk Factors</keyword>
  <keyword>Major Adverse Cardiovascular Events</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Retinal Vein Occlusion</mesh_term>
    <mesh_term>Thrombosis</mesh_term>
    <mesh_term>Atherosclerosis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02257333
org study id: HEART VISION
nct id: NCT02257333
lead sponsor: 
collaborator: 
has dmc: No
The retinal vein occlusion (RVO) is the second most common retinal disease after diabetic
      retinopathy, and is a common cause of unilateral visual loss. The risk factors that
      predispose to RVO are many and are generally the same as those found in vascular alterations
      involving other parts of the body, as in the case of stroke or coronary heart disease.
      Several authors have attempted to determine whether the pathogenesis of RVO can be of
      arterial type, considering the disease as consequent to atherosclerosis, rather than
      resulting from venous disease. Although less frequent than the other diseases RVO affects
      considerably on health care costs. Direct medical costs showed that in one year a patient
      with this disease has a higher than average cost for a patient with hypertension or glaucoma.
      Knowing the prevalence of the disease in Italy and identify modifiable risk factors,
      recognizing additional risk factors related to gender, genetic predisposition and especially
      the social-economic and cultural background in the pathogenesis of RVO, are the objectives
      that led to the planning of this study. In order to assess the prevalence of the disease and
      the current "clinical practice" we aim to create an online register between Italian
      specialist centers (ophthalmic emergency care and thrombosis centers) with immediate
      portability and usability of the data.
The retinal vein occlusion (RVO) is the second most common retinal disease after diabetic
      retinopathy, and is a common cause of unilateral visual loss. The occlusion of a branch of
      the central retinal vein (BRVO) and central retinal vein occlusion (CRVO) are two topics
      discussed and very deserving of further study, especially for the need of greater clarity
      arising from the availability of new diagnostic and especially therapeutic opportunities.

      The literature on the prevalence of RVO is not particularly rich, and the results of the
      available studies are very heterogeneous because such studies are conducted on a few cases,
      using different methodologies and are mainly characterized by a different distribution of
      risk factors among the different populations. In this regard, it was particularly interesting
      a publication of 2010 which proposed a combined analysis of the main study population
      (population based study).

      The sample of the final analysis was of 49 869 subjects, and the results showed that the
      retinal vein occlusion overall prevalence, standardized for age and sex, is 5.2 per 1000, of
      which 4.42 and 0.80 to BRVO and CRVO respectively. Despite the slightly higher prevalence in
      females, this difference wasn't statistically significant.

      In contrast, the prevalence of venous occlusion increases with increasing age in a
      statistically significant manner, both in the overall analysis of the occlusions of branch
      and central, that for the individual entities. This pattern is characteristic of chronic
      degenerative diseases and in fact the RVO has a behavior very similar to that of these
      diseases, probably because the risk factors (especially those such as atherosclerosis and
      systemic hypertension) increases with age.

      The results provided by these systematic analysis are particularly important because they
      provide a reliable estimate of RVO prevalence in general population; must be considered,
      however, the inherent limitations mainly concerning potential sources of heterogeneity, such
      as different methodologies used, the fact that most of the studies were carried out on a
      single ethnic group, often with different distribution of risk factors and therefore were not
      suitable to capture these differences.

      The risk factors predisposing to RVO are many and are generally the same as those found in
      vascular alterations involving other parts of the body as in the case of stroke or coronary
      heart disease. Several authors have attempted to determine whether the disease can be
      consequent to atherosclerosis and therefore caused by arterial disease rather than the
      pathogenesis of venous disease.

      There is a very variable delay between the onset of symptoms and initiation of treatment; the
      excessive delay of treatment was considered an exclusion criterion in only a minority of the
      studies considered. Although it is very difficult to estimate the age of the thrombotic
      event, early identification is surely preferable and the treatment time is a critical factor
      to evaluate the efficacy of a therapeutic strategy. Because of the relatively small number of
      patients is not possible to determine which therapy is more effective.

      Recently new experimental therapeutic approaches have been proposed, such as intravitreal
      administration of various drugs (steroids, anti-VEGF). It is not yet clear whether these
      approaches can eliminate the need for anticoagulant therapy during the acute phase of the
      disease. Surely antithrombotic drugs may have a role in the treatment of the acute phase of
      the RVO, at least in some categories of patients, and can be used in association with
      intravitreal drugs. Future studies should also explore the possibility of combined
      approaches. The retinal vein occlusion is a disease related to age and surely there will be
      an increase in social-economic impact of this disease due to the increase in population of
      the most advanced age group.

      To assess the social-economic impact should be considered in addition to visual impairment
      related to the disease, the impact on quality of life of the patient and the direct medical
      costs of retinal vein thrombosis have shown that in one year a patient with this disease has
      an average cost 20% higher than a hypertensive patient (BRVO: + 16%; CRVO: + 22%) or glaucoma
      ones (BRVO: + 18%; CRVO: + 24%); Therefore, although it is less frequent than the other
      diseases RVO affects considerably on health care costs. The data available in the literature
      show that in the overall one year management, direct costs that have the greatest impact, in
      percentage terms, are the costs associated with ocular pathology caused by acute event
      (thrombosis) and diagnostic tests. After three years, however, the cost is linked to systemic
      disease (hospitalization) has a bigger impact in percentage terms, as if to indicate that
      retinal vein thrombosis is nothing more than an epiphenomenon of systemic disease.

      Operating Modes The study will be divided into 4 phases: Step 1: establishment of the
      network: identification of specialized facilities (ophthalmic emergency care and thrombosis
      centers), which may accept patients with suspected RVO, which will participate in the
      establishment of the register online; Step 2: Create the registry and recruitment of patients
      cohort; Step 3: Follow-up planned (1 month) for instrumental tests to confirm the diagnosis
      of RVO; Step 4: Observational follow-up supported by dedicated web platform for the
      identification of major adverse cardiovascular events, in order to export in the context of
      clinical acquisitions epidemiological and disease management in real time.
observational model: Case-Only
time perspective: Prospective
measure: Retinal Venous Occlusion Prevalence
time frame: Baseline
description: The primary outcome result is about the description of RVO prevalence among the study population.
measure: Atherosclerotic Risk Profile in RVO
time frame: Baseline
description: The second primary outcome is to identify and describe the atherosclerotic burden and the atherosclerosis risk factors prevalence among RVO patients.
measure: Visual Acuity
time frame: 2 Years
description: To evaluate visual acuty in a long time frame after RVO. Visual acuity will be assessed according to Snellen and ETDRS scales.
measure: Major Adverse Cardiovascular Events
time frame: 2 Years
description: Evaluate incidence and prevalence of MACE among patients with RVO
measure: RVO Recurrence
time frame: 2 Years
description: It will be evaluated wheter the first RVO episode could be a risk factor for the occurence of a new RVO.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stefania Basili, MD
role: Study Chair
affiliation: University of Roma La Sapienza
last name: Elena Pacella, MD
role: Study Chair
affiliation: University of Roma La Sapienza
last name: Enzo M Vingolo, MD
role: Principal Investigator
affiliation: University of Roma La Sapienza
last name: Valeria Raparelli, MD, PhD
role: Principal Investigator
affiliation: University of Roma La Sapienza
last name: Marco Proietti, MD, PhD
role: Principal Investigator
affiliation: University of Roma La Sapienza
last name: Stefania Basili, MD
phone: 0649974678
phone ext: +39
email: stefania.basili@uniroma1.it
last name: Elena Pacella, MD
email: elena.pacella@uniroma1.it
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Roma La Sapienza
investigator full name: Stefania Basili
investigator title: Associate Professor
mesh term: Retinal Vein Occlusion
mesh term: Thrombosis
mesh term: Atherosclerosis