<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/NCT03840265</url>
  </required_header>
  <id_info>
    <org_study_id>SemmelweisUHVC</org_study_id>
    <nct_id>NCT03840265</nct_id>
  </id_info>
  <brief_title>Evaluation of Cerebrovascular Events in Patients With Occlusive Carotid Artery Disorders</brief_title>
  <official_title>Evaluation of Cerebrovascular Events in Patients With Occlusive Carotid Artery Disorders Based on Morphological and Hemodynamical Features</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Semmelweis University Heart and Vascular Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Research, Development and Innovation Office</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Semmelweis University Heart and Vascular Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      As of today, no suitable multiparametric predictive method is available to properly estimate&#xD;
      stroke risk in patients with carotid artery stenosis. Carotid artery stenosis is one of the&#xD;
      proven risk factors of stroke incidence, but the indication of its intervention is merely the&#xD;
      grade of stenosis itself. The current international guidelines suggest intervention for&#xD;
      asymptomatic patients only with potentially high risk plaques but pharmacological treatment&#xD;
      is advised to low risk patients. Unfortunately there is no proven and widely accepted system&#xD;
      to distinguish these two categories of patients with carotid artery stenosis.&#xD;
&#xD;
      In this project the following parameters will be assessed both in asymptomatic and&#xD;
      symptomatic patients: 1, preoperative stroke risk prediction based on comparative analysis of&#xD;
      CT angiography (CTA) results of plaque morphology and ultrasound (US) based plaque&#xD;
      elastography analysis, 2) intracranial bloodflow will be measured by transcranial Doppler&#xD;
      sonography(TCD), 3) presence recent of silent brain ischemia on diffusion weighted imaging&#xD;
      (DWI) MR (magnetic resonance), 4) retinal perfusion measurement by optical coherence&#xD;
      tomography angiography (OCT). The investigators aim to establish a clinically meaningful and&#xD;
      more accurate (than stenosis grade) stroke risk prediction algorithm for asymptomatic carotid&#xD;
      stenosis patients based on these parameters.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Stroke is one of the leading causes of mortality in Hungary. While stroke mortality is&#xD;
      8-10/100.000 in the population under 50 years of age in Western European countries, the&#xD;
      mortality is 40/100.000 in women and 60/100.000 in men in Hungary. In the investigators'&#xD;
      country the stroke patients are 5-10 years younger as compared to other developed countries.&#xD;
      The total stroke mortality in the first 24 months in Hungary is approximately 30%,&#xD;
      furthermore 32-42% of the survivors need permanent help in completing their daily routine&#xD;
      tasks. Carotid artery disease of atherosclerotic origin is common in the elderly population.&#xD;
      The cause of cerebral ischemia in approximately half of the patients is due to the rupture of&#xD;
      atherosclerotic plaque with subsequent embolization of thrombus and/or plaque material in the&#xD;
      cerebral circulation. Prevention of cerebral ischemia is the goal of pharmacological or&#xD;
      surgical treatment. The decision for surgical treatment such as carotid endarterectomy (CEA)&#xD;
      or carotid artery stenting (CAS) is based on the degree of stenosis, but incorporating&#xD;
      non-invasive measures of plaque composition is expected to improve the selection of patients&#xD;
      that will benefit from surgical intervention. The number of asymptomatic patients with&#xD;
      carotid stenosis needed to treat to prevent one stroke with endarterectomy is 20, which is&#xD;
      quite high compared to 8 in the symptomatic patient group. There is a clear need to identify&#xD;
      asymptomatic individuals at high risk of developing future ischemic events to avoid&#xD;
      unnecessary surgery. It has been remarked, that the recent AHA (American Heart Association)&#xD;
      guideline on the management of significant asymptomatic carotid stenosis recommends that&#xD;
      surgery may be considered in highly selected patients. However, no guidance was provided as&#xD;
      to which patient is the &quot;highly selected&quot; one.&#xD;
&#xD;
      As of today, no suitable predictive method is available to properly estimate stroke risk in&#xD;
      patients with carotid artery stenosis. Carotid artery stenosis is one of the proven risk&#xD;
      factors of stroke incidence, but the indication of its intervention is merely the grade of&#xD;
      stenosis itself. The current international guidelines suggest intervention for asymptomatic&#xD;
      patients only with potentially high risk plaques, but pharmacological treatment is advised&#xD;
      for low risk patients. Unfortunately there is no proven and widely accepted system to&#xD;
      distinguish these two categories of patients with carotid artery stenosis.&#xD;
&#xD;
      Aims:&#xD;
&#xD;
      The investigators' aim is to establish a stroke risk prediction score system -based on CTA&#xD;
      and US plaque morphology and blood sample biomarkers- for asymptomatic carotid artery&#xD;
      stenosis patients. A more specific and more accurate system -than the currently applied&#xD;
      stroke risk score systems- would allow for the selection of the potentially high risk plaques&#xD;
      in asymptomatic patients with borderline grade stenosis.These patients would benefit more&#xD;
      from surgical treatment while asymptomatic patients with low risk plaques could avoid the&#xD;
      risk of an invasive treatment.&#xD;
&#xD;
        1. Morphological features related to surgical related cerebrovascular events: The&#xD;
           investigators plan to overview the clinical records retrospectively to find&#xD;
           morphological, hemodynamical and clinical predictors of intra- and early postoperative&#xD;
           cause of the cerebrovascular events. An isolated middle cerebral artery carries higher&#xD;
           risk of immediate neurological event after carotid endarterectomy with cross-clamping&#xD;
           without shunt protection. This project's secondary aims are the following: to compare&#xD;
           the accuracy of the CTA and MR imaging in the assessment of the Circle of Willis (CoW)&#xD;
           morphology in all patients before CEA and to evaluate changes in CoW morphology before&#xD;
           and after CEA, to compare ischemic changes before and after CEA regarding CoW&#xD;
           morphology, shunt usage and to evaluate the impact of contralateral carotid occlusion on&#xD;
           immediate neurological event (INE) regarding CoW and other supra-aortic morphology.&#xD;
           Retrospective assessment of the correlation between intracranial vascular morphology&#xD;
           with CTA and intraoperative stroke risk would provide help in perioperative stroke risk&#xD;
           prediction and planning of optimal surgical technique.&#xD;
&#xD;
        2. Micro-embolization and carotid plaque analysis: The investigators aim is to define a&#xD;
           group of patients in the study cohort, who are clinically asymptomatic, but suffered&#xD;
           silent brain ischemia (SBI) before surgery, and to analyze their plaque using a&#xD;
           dedicated software for plaque assessment (Medis QAngioCT) and compare to asymptomatic&#xD;
           without SBI and symptomatic patients plaques. In Hungary the gold standard of the&#xD;
           preoperative imaging of carotid artery stenosis in asymptomatic and symptomatic patients&#xD;
           is CTA. These images can be used for plaque analysis that is to identify vulnerable&#xD;
           plaque morphology in coronary arteries. The identification of preoperative plaque&#xD;
           vulnerability based on the comparison of the ultrasound plaque elastography and contrast&#xD;
           enhanced plaque analysis, the transcranial Doppler ultrasound (which can detect&#xD;
           microembolisation), cranial DWI-MR for verification of silent recent ischaemic lesions&#xD;
           and the histopathology of surgically removed plaques with CTA and US based plaque&#xD;
           morphology can define vulnerable plaques related to adverse events.&#xD;
&#xD;
        3. Evaluation of retinal perfusion changes following carotid interventions using OCT&#xD;
           angiography in patients with carotid stenosis to assess the influence of carotid&#xD;
           stenting and carotid endarterectomy on retinal perfusion using OCTA in patients with&#xD;
           significant carotid artery stenosis. Furthermore, this study evaluates the predictive&#xD;
           accuracy of retinal microvasculature alterations on the development of postoperative&#xD;
           stroke. Carotid artery occlusive disease may result in different vision threatening&#xD;
           ocular manifestations, for instance, retinal vascular occlusions and ocular ischemic&#xD;
           syndrome (OIS). The diagnosis of carotid stenosis is critical as it is an important risk&#xD;
           factor of serious cerebrovascular disease. OCT angiography could be a useful&#xD;
           non-invasive method for early diagnosis of patients with carotid stenosis and to&#xD;
           evaluate the outcome of carotid interventions. Better identification of patients with&#xD;
           carotid stenosis is crucial for the prevention of vision loss and stroke.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 6, 2019</start_date>
  <completion_date type="Anticipated">November 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">November 30, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Neurological event</measure>
    <time_frame>Periprocedural (0-78h after the carotid endarterectomy)</time_frame>
    <description>Neurological event can be definitive stroke or transient ischemic attack (TIA). Any neurological events, which can occur in the postoperative 0-78 hours is defined as neurological event. The patients with neurological event will be scored in Rankin scale and will undergo cranial CT and CTA to verify the acute brain ischemia. Patients without any neurological event, who has silent new DWI lesions in postoperative cranial MR, count to be asymptomatic and do not fulfill the positive outcome criteria. Patients with peripheral nerve damage (common complication of cervical operations) count to be asymptomatic and do not fulfill the positive outcome criteria.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Carotid Stenosis</condition>
  <condition>Carotid Artery Plaque</condition>
  <condition>Cerebrovascular Embolism and Thrombosis</condition>
  <arm_group>
    <arm_group_label>Carotid endarterectomy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>All patients in this study will undergo carotid endarterectomy procedure</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>carotid endarterectomy</intervention_name>
    <description>In this project the following parameters will be assessed both in asymptomatic and symptomatic patients underwent carotid endarterectomy: 1) hemodynamic modeling of effect of the supraaortic arteries anatomic variations and pathologies 2, preoperative stroke risk prediction based on comparative analysis of CTA results of plaque morphology and ultrasound-based plaque elastography analysis, 3) cerebral flow measurement by transcranial Doppler sonography(TCD), 4) presence recent of silent brain ischemia on DWI-MRI, 5) OCT angiography could be a useful non-invasive method for evaluation of the outcome of carotid interventions</description>
    <arm_group_label>Carotid endarterectomy</arm_group_label>
    <other_name>Cranial MR</other_name>
    <other_name>Transcranial Doppler Ultrasound</other_name>
    <other_name>Optical coherence tomography angiography</other_name>
    <other_name>Carotid CT angiography</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  signed informed consent,&#xD;
&#xD;
          -  significant carotid artery stenosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age under 50 years&#xD;
&#xD;
          -  Neurological event 15 days before operation&#xD;
&#xD;
          -  Chronic kidney disease&#xD;
&#xD;
          -  Pacemaker or ICD implantation&#xD;
&#xD;
          -  Atrial fibrillation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Péter Sótonyi, MD PhD</last_name>
    <role>Study Director</role>
    <affiliation>Semmelweis University Heart and Vascular Centre</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Zsuzsanna Mihály, MD</last_name>
    <phone>+36-20-666-3673</phone>
    <email>zsuzsannamihaly@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Claudia Halász</last_name>
    <phone>+36-20-666-3227</phone>
    <email>halasz.claudia@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Semmelweis University Heart and Vascular Centre</name>
      <address>
        <city>Budapest</city>
        <state>Budapest XII</state>
        <zip>1122</zip>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zsuzsanna Mihály</last_name>
      <phone>+36-20-666-3673</phone>
      <email>zsuzsannamihaly@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Hungary</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>February 12, 2019</study_first_submitted>
  <study_first_submitted_qc>February 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>March 18, 2020</last_update_submitted>
  <last_update_submitted_qc>March 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Semmelweis University Heart and Vascular Center</investigator_affiliation>
    <investigator_full_name>Prof. Dr. Sótonyi Péter</investigator_full_name>
    <investigator_title>MD, PhD, Head of Vascular Surgery Department of Semmelweis University</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carotid Stenosis</mesh_term>
    <mesh_term>Carotid Artery Diseases</mesh_term>
    <mesh_term>Thrombosis</mesh_term>
    <mesh_term>Embolism</mesh_term>
    <mesh_term>Embolism and Thrombosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03840265
org study id: SemmelweisUHVC
nct id: NCT03840265
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
As of today, no suitable multiparametric predictive method is available to properly estimate
      stroke risk in patients with carotid artery stenosis. Carotid artery stenosis is one of the
      proven risk factors of stroke incidence, but the indication of its intervention is merely the
      grade of stenosis itself. The current international guidelines suggest intervention for
      asymptomatic patients only with potentially high risk plaques but pharmacological treatment
      is advised to low risk patients. Unfortunately there is no proven and widely accepted system
      to distinguish these two categories of patients with carotid artery stenosis.

      In this project the following parameters will be assessed both in asymptomatic and
      symptomatic patients: 1, preoperative stroke risk prediction based on comparative analysis of
      CT angiography (CTA) results of plaque morphology and ultrasound (US) based plaque
      elastography analysis, 2) intracranial bloodflow will be measured by transcranial Doppler
      sonography(TCD), 3) presence recent of silent brain ischemia on diffusion weighted imaging
      (DWI) MR (magnetic resonance), 4) retinal perfusion measurement by optical coherence
      tomography angiography (OCT). The investigators aim to establish a clinically meaningful and
      more accurate (than stenosis grade) stroke risk prediction algorithm for asymptomatic carotid
      stenosis patients based on these parameters.
Stroke is one of the leading causes of mortality in Hungary. While stroke mortality is
      8-10/100.000 in the population under 50 years of age in Western European countries, the
      mortality is 40/100.000 in women and 60/100.000 in men in Hungary. In the investigators'
      country the stroke patients are 5-10 years younger as compared to other developed countries.
      The total stroke mortality in the first 24 months in Hungary is approximately 30%,
      furthermore 32-42% of the survivors need permanent help in completing their daily routine
      tasks. Carotid artery disease of atherosclerotic origin is common in the elderly population.
      The cause of cerebral ischemia in approximately half of the patients is due to the rupture of
      atherosclerotic plaque with subsequent embolization of thrombus and/or plaque material in the
      cerebral circulation. Prevention of cerebral ischemia is the goal of pharmacological or
      surgical treatment. The decision for surgical treatment such as carotid endarterectomy (CEA)
      or carotid artery stenting (CAS) is based on the degree of stenosis, but incorporating
      non-invasive measures of plaque composition is expected to improve the selection of patients
      that will benefit from surgical intervention. The number of asymptomatic patients with
      carotid stenosis needed to treat to prevent one stroke with endarterectomy is 20, which is
      quite high compared to 8 in the symptomatic patient group. There is a clear need to identify
      asymptomatic individuals at high risk of developing future ischemic events to avoid
      unnecessary surgery. It has been remarked, that the recent AHA (American Heart Association)
      guideline on the management of significant asymptomatic carotid stenosis recommends that
      surgery may be considered in highly selected patients. However, no guidance was provided as
      to which patient is the "highly selected" one.

      As of today, no suitable predictive method is available to properly estimate stroke risk in
      patients with carotid artery stenosis. Carotid artery stenosis is one of the proven risk
      factors of stroke incidence, but the indication of its intervention is merely the grade of
      stenosis itself. The current international guidelines suggest intervention for asymptomatic
      patients only with potentially high risk plaques, but pharmacological treatment is advised
      for low risk patients. Unfortunately there is no proven and widely accepted system to
      distinguish these two categories of patients with carotid artery stenosis.

      Aims:

      The investigators' aim is to establish a stroke risk prediction score system -based on CTA
      and US plaque morphology and blood sample biomarkers- for asymptomatic carotid artery
      stenosis patients. A more specific and more accurate system -than the currently applied
      stroke risk score systems- would allow for the selection of the potentially high risk plaques
      in asymptomatic patients with borderline grade stenosis.These patients would benefit more
      from surgical treatment while asymptomatic patients with low risk plaques could avoid the
      risk of an invasive treatment.

        1. Morphological features related to surgical related cerebrovascular events: The
           investigators plan to overview the clinical records retrospectively to find
           morphological, hemodynamical and clinical predictors of intra- and early postoperative
           cause of the cerebrovascular events. An isolated middle cerebral artery carries higher
           risk of immediate neurological event after carotid endarterectomy with cross-clamping
           without shunt protection. This project's secondary aims are the following: to compare
           the accuracy of the CTA and MR imaging in the assessment of the Circle of Willis (CoW)
           morphology in all patients before CEA and to evaluate changes in CoW morphology before
           and after CEA, to compare ischemic changes before and after CEA regarding CoW
           morphology, shunt usage and to evaluate the impact of contralateral carotid occlusion on
           immediate neurological event (INE) regarding CoW and other supra-aortic morphology.
           Retrospective assessment of the correlation between intracranial vascular morphology
           with CTA and intraoperative stroke risk would provide help in perioperative stroke risk
           prediction and planning of optimal surgical technique.

        2. Micro-embolization and carotid plaque analysis: The investigators aim is to define a
           group of patients in the study cohort, who are clinically asymptomatic, but suffered
           silent brain ischemia (SBI) before surgery, and to analyze their plaque using a
           dedicated software for plaque assessment (Medis QAngioCT) and compare to asymptomatic
           without SBI and symptomatic patients plaques. In Hungary the gold standard of the
           preoperative imaging of carotid artery stenosis in asymptomatic and symptomatic patients
           is CTA. These images can be used for plaque analysis that is to identify vulnerable
           plaque morphology in coronary arteries. The identification of preoperative plaque
           vulnerability based on the comparison of the ultrasound plaque elastography and contrast
           enhanced plaque analysis, the transcranial Doppler ultrasound (which can detect
           microembolisation), cranial DWI-MR for verification of silent recent ischaemic lesions
           and the histopathology of surgically removed plaques with CTA and US based plaque
           morphology can define vulnerable plaques related to adverse events.

        3. Evaluation of retinal perfusion changes following carotid interventions using OCT
           angiography in patients with carotid stenosis to assess the influence of carotid
           stenting and carotid endarterectomy on retinal perfusion using OCTA in patients with
           significant carotid artery stenosis. Furthermore, this study evaluates the predictive
           accuracy of retinal microvasculature alterations on the development of postoperative
           stroke. Carotid artery occlusive disease may result in different vision threatening
           ocular manifestations, for instance, retinal vascular occlusions and ocular ischemic
           syndrome (OIS). The diagnosis of carotid stenosis is critical as it is an important risk
           factor of serious cerebrovascular disease. OCT angiography could be a useful
           non-invasive method for early diagnosis of patients with carotid stenosis and to
           evaluate the outcome of carotid interventions. Better identification of patients with
           carotid stenosis is crucial for the prevention of vision loss and stroke.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Neurological event
time frame: Periprocedural (0-78h after the carotid endarterectomy)
description: Neurological event can be definitive stroke or transient ischemic attack (TIA). Any neurological events, which can occur in the postoperative 0-78 hours is defined as neurological event. The patients with neurological event will be scored in Rankin scale and will undergo cranial CT and CTA to verify the acute brain ischemia. Patients without any neurological event, who has silent new DWI lesions in postoperative cranial MR, count to be asymptomatic and do not fulfill the positive outcome criteria. Patients with peripheral nerve damage (common complication of cervical operations) count to be asymptomatic and do not fulfill the positive outcome criteria.
arm group label: Carotid endarterectomy
arm group type: Other
description: All patients in this study will undergo carotid endarterectomy procedure
intervention type: Procedure
intervention name: carotid endarterectomy
description: In this project the following parameters will be assessed both in asymptomatic and symptomatic patients underwent carotid endarterectomy: 1) hemodynamic modeling of effect of the supraaortic arteries anatomic variations and pathologies 2, preoperative stroke risk prediction based on comparative analysis of CTA results of plaque morphology and ultrasound-based plaque elastography analysis, 3) cerebral flow measurement by transcranial Doppler sonography(TCD), 4) presence recent of silent brain ischemia on DWI-MRI, 5) OCT angiography could be a useful non-invasive method for evaluation of the outcome of carotid interventions
arm group label: Carotid endarterectomy
other name: Cranial MR
other name: Transcranial Doppler Ultrasound
other name: Optical coherence tomography angiography
other name: Carotid CT angiography
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Péter Sótonyi, MD PhD
role: Study Director
affiliation: Semmelweis University Heart and Vascular Centre
last name: Zsuzsanna Mihály, MD
phone: +36-20-666-3673
email: zsuzsannamihaly@gmail.com
last name: Claudia Halász
phone: +36-20-666-3227
email: halasz.claudia@gmail.com
facility: 
status: Recruiting
contact: 
country: Hungary
responsible party type: Principal Investigator
investigator affiliation: Semmelweis University Heart and Vascular Center
investigator full name: Prof. Dr. Sótonyi Péter
investigator title: MD, PhD, Head of Vascular Surgery Department of Semmelweis University
mesh term: Carotid Stenosis
mesh term: Carotid Artery Diseases
mesh term: Thrombosis
mesh term: Embolism
mesh term: Embolism and Thrombosis
sharing ipd: Undecided