<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/NCT03041493</url>
  </required_header>
  <id_info>
    <org_study_id>17-071</org_study_id>
    <nct_id>NCT03041493</nct_id>
  </id_info>
  <brief_title>Investigation of the Effects of Electronic Cigarettes on Vascular Health</brief_title>
  <official_title>Investigation of the Effects of Electronic Cigarettes on Vascular Health</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Memorial Sloan Kettering Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Weill Medical College of Cornell University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Memorial Sloan Kettering Cancer Center</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal is find out if the use of Electronic cigarettes (EC) leads to the same changes that&#xD;
      we see in blood vessels of traditional cigarettes (TC) users. The investigators will also&#xD;
      enroll non-smokers as &quot;controls&quot;, against which they will measure changes in blood vessels in&#xD;
      TC and EC users.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Lack of accrual&#xD;
  </why_stopped>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Actual">June 11, 2021</completion_date>
  <primary_completion_date type="Actual">June 11, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>This is a prospective, non-randomized case controlled study of the effects of electronic cigarettes on vascular health. The study population will comprise the three groups based on the criteria EC users (experimental group), (TC) smokers (positive control) and nonsmokers (negative control).</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Differences in levels of F2-isoprostanes in participants</measure>
    <time_frame>2 years</time_frame>
    <description>F2-isoprostanes in blood and urine</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Vascular Health</condition>
  <arm_group>
    <arm_group_label>Electronic cigarettes (EC) smokers</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>traditional cigarette (TC) smokers</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>nonsmokers</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Electronic cigarette</intervention_name>
    <description>During the first encounter, blood pressure and endothelium-dependent relaxation (EDR) will be measured by flow mediated dilatation (FMD), and a small peripheral IV catheter will be placed in the participant's median antecubital or cephalic vein. A blood sample (10 mL) for EPCs and F2-isoprostanes will be collected. One urine sample will also be collected for measurement of urinary F2-isoprostanes, cotinine and creatinine. These will serve as both baseline measures for subsequent acute exposure to nicotine and as measures of chronic nicotine exposure. The second encounter will be scheduled 4 hours after the first encounter. At that time a blood sample (5 mL) for EPCs will be collected followed by harvesting of vascular endothelial cells for eNOS and NF-κB expression.</description>
    <arm_group_label>Electronic cigarettes (EC) smokers</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>traditional cigarette</intervention_name>
    <description>During the first encounter, blood pressure and endothelium-dependent relaxation (EDR) will be measured by flow mediated dilatation (FMD), and a small peripheral IV catheter will be placed in the participant's median antecubital or cephalic vein. A blood sample (10 mL) for EPCs and F2-isoprostanes will be collected. One urine sample will also be collected for measurement of urinary F2-isoprostanes, cotinine and creatinine. These will serve as both baseline measures for subsequent acute exposure to nicotine and as measures of chronic nicotine exposure. The second encounter will be scheduled 4 hours after the first encounter. At that time a blood sample (5 mL) for EPCs will be collected followed by harvesting of vascular endothelial cells for eNOS and NF-κB expression.</description>
    <arm_group_label>traditional cigarette (TC) smokers</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>(sham cigarette) - no actual exposure to cigarettes</intervention_name>
    <description>During the first encounter, blood pressure and endothelium-dependent relaxation (EDR) will be measured by flow mediated dilatation (FMD), and a small peripheral IV catheter will be placed in the participant's median antecubital or cephalic vein. A blood sample (10 mL) for EPCs and F2-isoprostanes will be collected. One urine sample will also be collected for measurement of urinary F2-isoprostanes, cotinine and creatinine. These will be compared to the second set of laboratory measurements done at the second encounter that will be scheduled 4 hours after the first encounter. At that time an additional blood sample (5 mL) for EPCs will be collected followed by harvesting of vascular endothelial cells for eNOS and NF-κB expression.</description>
    <arm_group_label>nonsmokers</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female between 18 and 50 years of age.&#xD;
&#xD;
          -  Good general health with no history of diabetes, coronary artery disease, peripheral&#xD;
             arterial disease, chronic disease or hypertension.&#xD;
&#xD;
          -  Ability to sign an informed consent.&#xD;
&#xD;
        Tobacco product users will have additional inclusion criteria:&#xD;
&#xD;
          -  For TC smokers, daily TC smoking in the past 6 months, at least 10 cigarettes per day,&#xD;
             with no EC exposure in the past 6 months&#xD;
&#xD;
          -  For EC users, daily EC use in the past 6 months, at least 10 sessions per day, with no&#xD;
             TC exposure in the past 6 month&#xD;
&#xD;
          -  For non-smokers, no significant lifetime exposure to any nicotine-containing product,&#xD;
             where significant exposure is defined as daily use of any nicotine-containing product&#xD;
             for more than one week or once monthly use for more than 6 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of renal disease, hypertension, diabetes, congestive heart failure or&#xD;
             emphysema&#xD;
&#xD;
          -  Use of ACE inhibitors, Angiotensin II receptor blockers, diuretics, aldosterone, renin&#xD;
             blockers, aspirin, statins, sildenafil (or other PDE5 inhibitors) and NSAIDs.&#xD;
&#xD;
          -  History of substance abuse&#xD;
&#xD;
          -  Currently using nicotine replacement or other tobacco cessation products or&#xD;
             intentionally abstaining from nicotine-containing products&#xD;
&#xD;
          -  IV contrast exposure in the past 1 month&#xD;
&#xD;
          -  Inability to place an IV catheter or draw blood for any reason&#xD;
&#xD;
          -  Pregnant women or breastfeeding&#xD;
&#xD;
               -  Potential subjects will be asked if they are pregnant. Verbal confirmation of&#xD;
                  pregnancy will be sufficient.&#xD;
&#xD;
          -  Fever of &gt;101°F or BP &gt;180/95&#xD;
&#xD;
          -  BMI ≥30&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Roman Shingarev, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mskcc.org/mskcc/html/44.cfm</url>
    <description>Memorial Sloan Kettering Cancer Center</description>
  </link>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>February 1, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <last_update_submitted>June 14, 2021</last_update_submitted>
  <last_update_submitted_qc>June 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Electronic Cigarettes</keyword>
  <keyword>17-071</keyword>
  <!-- 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/NCT03041493
org study id: 17-071
nct id: NCT03041493
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The goal is find out if the use of Electronic cigarettes (EC) leads to the same changes that
      we see in blood vessels of traditional cigarettes (TC) users. The investigators will also
      enroll non-smokers as "controls", against which they will measure changes in blood vessels in
      TC and EC users.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: This is a prospective, non-randomized case controlled study of the effects of electronic cigarettes on vascular health. The study population will comprise the three groups based on the criteria EC users (experimental group), (TC) smokers (positive control) and nonsmokers (negative control).
primary purpose: Diagnostic
masking: None (Open Label)
measure: Differences in levels of F2-isoprostanes in participants
time frame: 2 years
description: F2-isoprostanes in blood and urine
arm group label: Electronic cigarettes (EC) smokers
arm group type: Experimental
arm group label: traditional cigarette (TC) smokers
arm group type: Experimental
arm group label: nonsmokers
arm group type: Active Comparator
intervention type: Behavioral
intervention name: Electronic cigarette
description: During the first encounter, blood pressure and endothelium-dependent relaxation (EDR) will be measured by flow mediated dilatation (FMD), and a small peripheral IV catheter will be placed in the participant's median antecubital or cephalic vein. A blood sample (10 mL) for EPCs and F2-isoprostanes will be collected. One urine sample will also be collected for measurement of urinary F2-isoprostanes, cotinine and creatinine. These will serve as both baseline measures for subsequent acute exposure to nicotine and as measures of chronic nicotine exposure. The second encounter will be scheduled 4 hours after the first encounter. At that time a blood sample (5 mL) for EPCs will be collected followed by harvesting of vascular endothelial cells for eNOS and NF-κB expression.
arm group label: Electronic cigarettes (EC) smokers
intervention type: Behavioral
intervention name: traditional cigarette
description: During the first encounter, blood pressure and endothelium-dependent relaxation (EDR) will be measured by flow mediated dilatation (FMD), and a small peripheral IV catheter will be placed in the participant's median antecubital or cephalic vein. A blood sample (10 mL) for EPCs and F2-isoprostanes will be collected. One urine sample will also be collected for measurement of urinary F2-isoprostanes, cotinine and creatinine. These will serve as both baseline measures for subsequent acute exposure to nicotine and as measures of chronic nicotine exposure. The second encounter will be scheduled 4 hours after the first encounter. At that time a blood sample (5 mL) for EPCs will be collected followed by harvesting of vascular endothelial cells for eNOS and NF-κB expression.
arm group label: traditional cigarette (TC) smokers
intervention type: Behavioral
intervention name: (sham cigarette) - no actual exposure to cigarettes
description: During the first encounter, blood pressure and endothelium-dependent relaxation (EDR) will be measured by flow mediated dilatation (FMD), and a small peripheral IV catheter will be placed in the participant's median antecubital or cephalic vein. A blood sample (10 mL) for EPCs and F2-isoprostanes will be collected. One urine sample will also be collected for measurement of urinary F2-isoprostanes, cotinine and creatinine. These will be compared to the second set of laboratory measurements done at the second encounter that will be scheduled 4 hours after the first encounter. At that time an additional blood sample (5 mL) for EPCs will be collected followed by harvesting of vascular endothelial cells for eNOS and NF-κB expression.
arm group label: nonsmokers
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Roman Shingarev, MD
role: Principal Investigator
affiliation: Memorial Sloan Kettering Cancer Center
facility: 
country: United States
url: http://www.mskcc.org/mskcc/html/44.cfm
description: Memorial Sloan Kettering Cancer Center
responsible party type: Sponsor