<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/NCT04468412</url>
  </required_header>
  <id_info>
    <org_study_id>NL2020-6555</org_study_id>
    <nct_id>NCT04468412</nct_id>
  </id_info>
  <brief_title>Influence of COVID-19 on Vascular Endothelial Function</brief_title>
  <acronym>COVAS</acronym>
  <official_title>Influence of COVID-19 on Vascular Endothelial Function</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Radboud University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bernhoven Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Radboud University Medical 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>
      Rationale: Infection with severe acute respiratory syndrome coronavirus (SARS-CoV) 2 could&#xD;
      result in endothelial dysfunction with increased risk of arterial thrombotic events by&#xD;
      downregulating the expression of angiotensin converting enzyme 2 (ACE2). Endothelial function&#xD;
      can be easily and non-invasively determined by carotid artery reactivity (CAR) testing.&#xD;
&#xD;
      Objective: To investigate the predictive value of endothelial dysfunction, measured by&#xD;
      carotid artery reactivity testing, for 1-year cardiovascular events in patients with past&#xD;
      COVID-19 infection.&#xD;
&#xD;
      Study design: A prospective observational longitudinal cohort study.&#xD;
&#xD;
      Study population: Patients recovered from confirmed infection with SARS-CoV2.&#xD;
&#xD;
      Main study parameters/endpoints: macrovascular endothelial function measured by carotid&#xD;
      artery reactivity testing.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">July 14, 2020</start_date>
  <completion_date type="Anticipated">March 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">March 30, 2022</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Endothelial dysfunction</measure>
    <time_frame>CAR will be measures between 6 and 20 weeks and 1 year after recovery from COVID-19.</time_frame>
    <description>Change in endothelial dysfunction as determined by CAR test.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Major adverse cardiovascular events (MACE)</measure>
    <time_frame>1 year</time_frame>
    <description>MACE include non-fatal myocardial infarction, non-fatal ischemic stroke, acute limb ischemia, need for revascularization, amputation and cardiovascular death.</description>
  </secondary_outcome>
  <enrollment type="Actual">203</enrollment>
  <condition>COVID</condition>
  <condition>Vascular; Damage</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Carotid Artery Reactivity Testing</intervention_name>
    <description>The carotid artery reactivity (CAR) test assesses macrovascular endothelial function by measuring the carotid artery diameter in response to sympathetic stimulation. Participants are in the supine position with the neck extended for assessment of the carotid artery. Left carotid artery diameter is recorded continuously during baseline (30 seconds) and during immersion of the right hand up to the wrist in icy water (4°C) for 3 minutes. CAR can either represent a dilatory response (normal endothelial function) or a constrictive response (endothelial dysfunction) of the carotid artery.</description>
    <other_name>Cold pressor test</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with past COVID-19 infection will be recruited at Bernhoven hospital, the&#xD;
        Netherlands.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Confirmed SARS-CoV2 infection by polymerase chain reaction on nasopharyngeal swab,&#xD;
             sputum or bronchoalveolar lavage.&#xD;
&#xD;
          -  At least 6 and no more than 20 weeks after resolution of COVID-19 related symptoms&#xD;
&#xD;
          -  ≥ 16 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Recent (&lt;3 months) angina pectoris, myocardial infarction, stroke, or heart failure&#xD;
&#xD;
          -  Raynaud syndrome, scleroderma, complex regional pain syndrome of the upper extremity&#xD;
             or presence of arteriovenous fistula or open wounds on both the upper extremities.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michiel C Warle, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Radboud University Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Andre S van Petersen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Benhoven</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bernhoven</name>
      <address>
        <city>Uden</city>
        <zip>5406 PT</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>January 17, 2022</last_update_submitted>
  <last_update_submitted_qc>January 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT04468412
org study id: NL2020-6555
nct id: NCT04468412
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Rationale: Infection with severe acute respiratory syndrome coronavirus (SARS-CoV) 2 could
      result in endothelial dysfunction with increased risk of arterial thrombotic events by
      downregulating the expression of angiotensin converting enzyme 2 (ACE2). Endothelial function
      can be easily and non-invasively determined by carotid artery reactivity (CAR) testing.

      Objective: To investigate the predictive value of endothelial dysfunction, measured by
      carotid artery reactivity testing, for 1-year cardiovascular events in patients with past
      COVID-19 infection.

      Study design: A prospective observational longitudinal cohort study.

      Study population: Patients recovered from confirmed infection with SARS-CoV2.

      Main study parameters/endpoints: macrovascular endothelial function measured by carotid
      artery reactivity testing.
observational model: Cohort
time perspective: Prospective
measure: Endothelial dysfunction
time frame: CAR will be measures between 6 and 20 weeks and 1 year after recovery from COVID-19.
description: Change in endothelial dysfunction as determined by CAR test.
measure: Major adverse cardiovascular events (MACE)
time frame: 1 year
description: MACE include non-fatal myocardial infarction, non-fatal ischemic stroke, acute limb ischemia, need for revascularization, amputation and cardiovascular death.
intervention type: Diagnostic Test
intervention name: Carotid Artery Reactivity Testing
description: The carotid artery reactivity (CAR) test assesses macrovascular endothelial function by measuring the carotid artery diameter in response to sympathetic stimulation. Participants are in the supine position with the neck extended for assessment of the carotid artery. Left carotid artery diameter is recorded continuously during baseline (30 seconds) and during immersion of the right hand up to the wrist in icy water (4°C) for 3 minutes. CAR can either represent a dilatory response (normal endothelial function) or a constrictive response (endothelial dysfunction) of the carotid artery.
other name: Cold pressor test
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Michiel C Warle, PhD
role: Principal Investigator
affiliation: Radboud University Medical Center
last name: Andre S van Petersen, PhD
role: Principal Investigator
affiliation: Benhoven
facility: 
country: Netherlands
responsible party type: Sponsor
sharing ipd: No