<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/NCT04428138</url>
  </required_header>
  <id_info>
    <org_study_id>ER.ALL.2018.30</org_study_id>
    <nct_id>NCT04428138</nct_id>
  </id_info>
  <brief_title>Inguinal Hernia and Arterial Disease</brief_title>
  <acronym>HEARD</acronym>
  <official_title>Observational Cross-sectional Study on the Association Between Inguinal Hernias and Arterial Diseases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Catanzaro</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Catanzaro</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Inguinal hernias are associated with problems related to the venous system by the linking to&#xD;
      extracellular matrix alterations (ECM). On the other hand, arterial diseases (arterial&#xD;
      aneurysms, carotid, stenosis, peripheral artery disease) are widespread in the general&#xD;
      population and may share others pathological pathways related to ECM impairment. Aim to this&#xD;
      study is to evaluate the prevalence of arterial diseases in patients with inguinal hernia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Previous studies showed the correlation between inguinal hernias and venous disease. The&#xD;
      common pathophysiological pathway between these clinical conditions is linked to&#xD;
      extracellular matrix (ECM) alterations. Arterial diseases, mainly represented by carotid&#xD;
      stenosis, peripheral artery disease and arterial aneurysms, are widespread in western&#xD;
      population and are responsible of high rates of morbidity and mortality. These diseases are&#xD;
      also related to some ECM alterations.&#xD;
&#xD;
      Aim of this cross-sectional study is to evaluate the prevalence of arterial disease among&#xD;
      patients with inguinal hernias. The primary endpoint of this study is to provide new&#xD;
      epidemiological evidences on this association that may help physicians in novel preventive&#xD;
      strategies. The study will consider the inclusion of consecutive patients assessed for&#xD;
      inguinal hernia over 1 year period in order to study the prevalence of concomitant arterial&#xD;
      disease, by means of office visit, echo duplex scan of the aorta and its main branches,&#xD;
      carotid arteries and lower limb arteries.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Anticipated">July 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of arterial disease in patients with inguinal hernia</measure>
    <time_frame>at 1 year</time_frame>
    <description>Patients with inguinal hernia will be assessed for the presence of arterial aneurysm, carotid stenosis, and peripheral artery disease in order to find any correlation between these pathological conditions.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Inguinal Hernia</condition>
  <condition>Arterial Disease</condition>
  <arm_group>
    <arm_group_label>Patients with Inguinal hernia</arm_group_label>
    <description>Patients presenting with inguinal hernia will undergo vascular in-office visit and echo duplex of aorta, carotid arteries and lower limb arteries in order to detect any abnormalities related to arterial disease (aneurysm, stenosis, flow alteration).</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>In-office vascular visit</intervention_name>
    <description>Every patient will undergo a complete physical examination in order to detect any clinical or sub clinical vascular disease.</description>
    <arm_group_label>Patients with Inguinal hernia</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Echo duplex scan of arterial system</intervention_name>
    <description>Every patient will undergo a complete echo duplex scan in order to detect any morphological or hemodynamic alteration of aorta, carotid arteries and lower limb arteries.</description>
    <arm_group_label>Patients with Inguinal hernia</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients of the general population presenting with inguinale hernia.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with inguinal hernia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with malignancies&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Raffaele Serra, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Magna Graecia of Catanzaro</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Raffaele Serra, M.D., Ph.D.</last_name>
    <phone>+3909613647380</phone>
    <email>rserra@unicz.it</email>
  </overall_contact>
  <location>
    <facility>
      <name>CIFL- Interuniversity Center of Phlebolymphology</name>
      <address>
        <city>Catanzaro</city>
        <zip>88100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Raffaele Serra, MD</last_name>
      <phone>+393387078043</phone>
      <email>rserra@unicz.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University Magna Graecia of Catanzaro</name>
      <address>
        <city>Catanzaro</city>
        <zip>88100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Raffaele Serra, M.D.; Ph.D.</last_name>
      <phone>+3909613647380</phone>
      <email>rserra@unicz.it</email>
    </contact>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Serra R, Buffone G, Costanzo G, Montemurro R, Scarcello E, Stillitano DM, Damiano R, de Franciscis S. Altered metalloproteinase-9 expression as least common denominator between varicocele, inguinal hernia, and chronic venous disorders. Ann Vasc Surg. 2014 Apr;28(3):705-9. doi: 10.1016/j.avsg.2013.07.026. Epub 2013 Oct 31.</citation>
    <PMID>24184457</PMID>
  </reference>
  <reference>
    <citation>Serra R, Buffone G, Costanzo G, Montemurro R, Perri P, Damiano R, de Franciscis S. Varicocele in younger as risk factor for inguinal hernia and for chronic venous disease in older: preliminary results of a prospective cohort study. Ann Vasc Surg. 2013 Apr;27(3):329-31. doi: 10.1016/j.avsg.2012.03.016. Epub 2012 Sep 19.</citation>
    <PMID>22998788</PMID>
  </reference>
  <reference>
    <citation>Rowse PG, Crestanello JA. Commentary: Abdominal wall hernia: An important risk association in aortic aneurysmal disease or just a dull ache? J Thorac Cardiovasc Surg. 2021 Dec;162(6):1678-1679. doi: 10.1016/j.jtcvs.2020.03.105. Epub 2020 Apr 6. No abstract available.</citation>
    <PMID>32448686</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 10, 2020</last_update_submitted>
  <last_update_submitted_qc>June 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Catanzaro</investigator_affiliation>
    <investigator_full_name>Prof. Raffaele Serra, MD, Ph.D.</investigator_full_name>
    <investigator_title>Associate Professor of Vascular Surgery</investigator_title>
  </responsible_party>
  <keyword>Inguinal Hernia</keyword>
  <keyword>Arterial Disease</keyword>
  <keyword>Peripheral artery disease</keyword>
  <keyword>Carotid stenosis</keyword>
  <keyword>Arterial aneurysm</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hernia</mesh_term>
    <mesh_term>Hernia, Inguinal</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04428138
org study id: ER.ALL.2018.30
nct id: NCT04428138
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Inguinal hernias are associated with problems related to the venous system by the linking to
      extracellular matrix alterations (ECM). On the other hand, arterial diseases (arterial
      aneurysms, carotid, stenosis, peripheral artery disease) are widespread in the general
      population and may share others pathological pathways related to ECM impairment. Aim to this
      study is to evaluate the prevalence of arterial diseases in patients with inguinal hernia.
Previous studies showed the correlation between inguinal hernias and venous disease. The
      common pathophysiological pathway between these clinical conditions is linked to
      extracellular matrix (ECM) alterations. Arterial diseases, mainly represented by carotid
      stenosis, peripheral artery disease and arterial aneurysms, are widespread in western
      population and are responsible of high rates of morbidity and mortality. These diseases are
      also related to some ECM alterations.

      Aim of this cross-sectional study is to evaluate the prevalence of arterial disease among
      patients with inguinal hernias. The primary endpoint of this study is to provide new
      epidemiological evidences on this association that may help physicians in novel preventive
      strategies. The study will consider the inclusion of consecutive patients assessed for
      inguinal hernia over 1 year period in order to study the prevalence of concomitant arterial
      disease, by means of office visit, echo duplex scan of the aorta and its main branches,
      carotid arteries and lower limb arteries.
observational model: Cohort
time perspective: Cross-Sectional
measure: Prevalence of arterial disease in patients with inguinal hernia
time frame: at 1 year
description: Patients with inguinal hernia will be assessed for the presence of arterial aneurysm, carotid stenosis, and peripheral artery disease in order to find any correlation between these pathological conditions.
arm group label: Patients with Inguinal hernia
description: Patients presenting with inguinal hernia will undergo vascular in-office visit and echo duplex of aorta, carotid arteries and lower limb arteries in order to detect any abnormalities related to arterial disease (aneurysm, stenosis, flow alteration).
intervention type: Diagnostic Test
intervention name: In-office vascular visit
description: Every patient will undergo a complete physical examination in order to detect any clinical or sub clinical vascular disease.
arm group label: Patients with Inguinal hernia
intervention type: Diagnostic Test
intervention name: Echo duplex scan of arterial system
description: Every patient will undergo a complete echo duplex scan in order to detect any morphological or hemodynamic alteration of aorta, carotid arteries and lower limb arteries.
arm group label: Patients with Inguinal hernia
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Raffaele Serra, M.D., Ph.D.
role: Principal Investigator
affiliation: University Magna Graecia of Catanzaro
last name: Raffaele Serra, M.D., Ph.D.
phone: +3909613647380
email: rserra@unicz.it
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Italy
citation: Serra R, Buffone G, Costanzo G, Montemurro R, Scarcello E, Stillitano DM, Damiano R, de Franciscis S. Altered metalloproteinase-9 expression as least common denominator between varicocele, inguinal hernia, and chronic venous disorders. Ann Vasc Surg. 2014 Apr;28(3):705-9. doi: 10.1016/j.avsg.2013.07.026. Epub 2013 Oct 31.
PMID: 24184457
citation: Serra R, Buffone G, Costanzo G, Montemurro R, Perri P, Damiano R, de Franciscis S. Varicocele in younger as risk factor for inguinal hernia and for chronic venous disease in older: preliminary results of a prospective cohort study. Ann Vasc Surg. 2013 Apr;27(3):329-31. doi: 10.1016/j.avsg.2012.03.016. Epub 2012 Sep 19.
PMID: 22998788
citation: Rowse PG, Crestanello JA. Commentary: Abdominal wall hernia: An important risk association in aortic aneurysmal disease or just a dull ache? J Thorac Cardiovasc Surg. 2021 Dec;162(6):1678-1679. doi: 10.1016/j.jtcvs.2020.03.105. Epub 2020 Apr 6. No abstract available.
PMID: 32448686
responsible party type: Principal Investigator
investigator affiliation: University of Catanzaro
investigator full name: Prof. Raffaele Serra, MD, Ph.D.
investigator title: Associate Professor of Vascular Surgery
mesh term: Hernia
mesh term: Hernia, Inguinal
sharing ipd: No