<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/NCT02991703</url>
  </required_header>
  <id_info>
    <org_study_id>RC16_0161</org_study_id>
    <nct_id>NCT02991703</nct_id>
  </id_info>
  <brief_title>Simplified Pulse Wave Velocity Measurement, Validation Study of the pOpmètre in Children</brief_title>
  <acronym>EPIPOP</acronym>
  <sponsors>
    <lead_sponsor>
      <agency>Nantes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nantes University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Arterial stiffness is an important marker of cardiovascular risk. It is measured by pulse&#xD;
      wave velocity. The reference device to measure pulse wave velocity is the Sphygmocor which&#xD;
      uses applanation tonometry. It is used in adults and children. An easier method called&#xD;
      pOpmètre using saturation sensors is validated in adults but not in children. The objective&#xD;
      of this study is to compare the pulse wave velocity values measured with the pOpmètre® with&#xD;
      those of the SphygmoCor® to validate the pOpmètre in children between 4 and 8 years old.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prematurity is associated with an increased risk of developing cardio-vascular diseases in&#xD;
      adulthood : a low birth weight linked to prematurity is correlated to a higher coronary&#xD;
      disease mortality rate, a higher blood pressure level in adulthood, to abnormal glucose&#xD;
      metabolism regulation, and to signs of nephron reduction. An independent marker of&#xD;
      cardiovascular risk is arterial stiffness: it is associated with a higher risk of major&#xD;
      cardiovascular events including stroke, acute coronary syndrome and complications of&#xD;
      end-stage renal disease. It is measured by pulse wave velocity which is the gold standard in&#xD;
      adulthood. Pulse wave velocity is also correlated to cardiovascular risk in childhood.&#xD;
      National cohort EPIPAGE II is made of 4290 premature babies born in 2011. A study is&#xD;
      scheduled at 5 years old and a half including a medical examination and a neuropsychological&#xD;
      evaluation. An ancillary study lengthening medical consultation for 15 minutes is scheduled&#xD;
      with 750 to 1000 of these children for a more precise vascular evaluation including pulse&#xD;
      wave velocity. Different methods can be used to measure pulse wave velocity in children:&#xD;
      these include applanation tonometry devices such as the SphygmoCor ® system. Its reference&#xD;
      values are well known in adulthood and were determined more recently in childhood. It is the&#xD;
      reference device but it is expensive, can be used only in expert health centres and time of&#xD;
      measurement is long. In children, an easier-to-use and faster device would be more&#xD;
      advantageous. The pOpmètre® uses 2 distal oxygen saturation sensors on finger and toe to&#xD;
      deduce pulse wave velocity. This device has already been validated in adults. The aim of this&#xD;
      study is to validate the pOpmètre in children between 4 and 8 years old. In that purpose,&#xD;
      patients are installed in the supine position, at rest. The child's mensurations are&#xD;
      measured. The two pOpmètre sensors are put on finger and toe. Blood pressure is measured by&#xD;
      an armband on the right limb. Then another armband is put around the thigh and a tonometer is&#xD;
      applied on the right carotid which allows pulse wave velocity measuring by the Sphygmocor.&#xD;
      Pulse wave velocity is measured with the pOpmètre using the time delay between finger pulse&#xD;
      signal and toe pulse signal. The values got with the two devices are compared using a Bland&#xD;
      and Altman graph. The pOpmètre is considered to be validated if the 95% confidence interval&#xD;
      of the bias is included between -0.5 m/sec and 0.5 m/sec that is about 10% of the normal&#xD;
      value at that age (5.0 m/s +/-0.13).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">November 2017</completion_date>
  <primary_completion_date type="Anticipated">November 2017</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>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference between the two simultaneous measurements of velocity of the pulse wave by the pOpmeter® and the Sphygmocor®.</measure>
    <time_frame>Day One</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Cardiovascular Diseases</condition>
  <condition>Arteriosclerosis</condition>
  <condition>Atherosclerosis</condition>
  <arm_group>
    <arm_group_label>SphygmoCor®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>pOpmètre®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>pOpmètre®</intervention_name>
    <description>the pOpmètre® uses saturation sensors,</description>
    <arm_group_label>pOpmètre®</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sphygmocor</intervention_name>
    <description>the Sphygmocor uses applanation tonometry</description>
    <arm_group_label>SphygmoCor®</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  children between 4 and 8 years old hospitalized in the Mother and Children Hospital in&#xD;
             Nantes during the study period.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Vasoconstrictor treatment,&#xD;
&#xD;
          -  compressive bandage on the measured area,&#xD;
&#xD;
          -  peripheral venous access on the measured side,&#xD;
&#xD;
          -  vascular surgery or pathology on the measured area,&#xD;
&#xD;
          -  significant pain or agitation,&#xD;
&#xD;
          -  parental or legal representative disapproval,&#xD;
&#xD;
          -  child disapproval.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>8 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jean-Christophe ROZE, Pr</last_name>
    <email>jeanchristophe.roze@chu-nantes.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Emma Allain-Launay, Dr</last_name>
    <phone>02 40 08 36 60</phone>
    <email>emma.allainlaunay@chu-nantes.fr</email>
  </overall_contact_backup>
  <link>
    <url>https://www.youtube.com/watch?v=4aFnQ_0_bOI</url>
    <description>Related Info</description>
  </link>
  <link>
    <url>http://www.axelife.fr/fr/index.php</url>
    <description>Related Info</description>
  </link>
  <reference>
    <citation>Willum-Hansen T, Staessen JA, Torp-Pedersen C, Rasmussen S, Thijs L, Ibsen H, Jeppesen J. Prognostic value of aortic pulse wave velocity as index of arterial stiffness in the general population. Circulation. 2006 Feb 7;113(5):664-70. doi: 10.1161/CIRCULATIONAHA.105.579342.</citation>
    <PMID>16461839</PMID>
  </reference>
  <reference>
    <citation>Urbina EM, Williams RV, Alpert BS, Collins RT, Daniels SR, Hayman L, Jacobson M, Mahoney L, Mietus-Snyder M, Rocchini A, Steinberger J, McCrindle B; American Heart Association Atherosclerosis, Hypertension, and Obesity in Youth Committee of the Council on Cardiovascular Disease in the Young. Noninvasive assessment of subclinical atherosclerosis in children and adolescents: recommendations for standard assessment for clinical research: a scientific statement from the American Heart Association. Hypertension. 2009 Nov;54(5):919-50. doi: 10.1161/HYPERTENSIONAHA.109.192639. Epub 2009 Sep 3. Erratum In: Hypertension. 2010 Sep;56(3):e36.</citation>
    <PMID>19729599</PMID>
  </reference>
  <reference>
    <citation>Ancel PY, Goffinet F; EPIPAGE 2 Writing Group. EPIPAGE 2: a preterm birth cohort in France in 2011. BMC Pediatr. 2014 Apr 9;14:97. doi: 10.1186/1471-2431-14-97.</citation>
    <PMID>24716860</PMID>
  </reference>
  <reference>
    <citation>Reference Values for Arterial Stiffness' Collaboration. Determinants of pulse wave velocity in healthy people and in the presence of cardiovascular risk factors: 'establishing normal and reference values'. Eur Heart J. 2010 Oct;31(19):2338-50. doi: 10.1093/eurheartj/ehq165. Epub 2010 Jun 7.</citation>
    <PMID>20530030</PMID>
  </reference>
  <reference>
    <citation>Reusz GS, Cseprekal O, Temmar M, Kis E, Cherif AB, Thaleb A, Fekete A, Szabo AJ, Benetos A, Salvi P. Reference values of pulse wave velocity in healthy children and teenagers. Hypertension. 2010 Aug;56(2):217-24. doi: 10.1161/HYPERTENSIONAHA.110.152686. Epub 2010 Jun 21.</citation>
    <PMID>20566959</PMID>
  </reference>
  <reference>
    <citation>Curcio S, Garcia-Espinosa V, Arana M, Farro I, Chiesa P, Giachetto G, Zocalo Y, Bia D. Growing-Related Changes in Arterial Properties of Healthy Children, Adolescents, and Young Adults Nonexposed to Cardiovascular Risk Factors: Analysis of Gender-Related Differences. Int J Hypertens. 2016;2016:4982676. doi: 10.1155/2016/4982676. Epub 2016 Feb 18.</citation>
    <PMID>26989504</PMID>
  </reference>
  <reference>
    <citation>Alivon M, Vo-Duc Phuong T, Vignon V, Bozec E, Khettab H, Hanon O, Briet M, Halimi JM, Hallab M, Plichart M, Mohammedi K, Marre M, Boutouyrie P, Laurent S. A novel device for measuring arterial stiffness using finger-toe pulse wave velocity: Validation study of the pOpmetre(R). Arch Cardiovasc Dis. 2015 Apr;108(4):227-34. doi: 10.1016/j.acvd.2014.12.003. Epub 2015 Feb 11.</citation>
    <PMID>25682547</PMID>
  </reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>November 23, 2016</study_first_submitted>
  <study_first_submitted_qc>December 9, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>December 9, 2016</last_update_submitted>
  <last_update_submitted_qc>December 9, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 13, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Arterial stiffness</keyword>
  <keyword>pulse wave velocity</keyword>
  <keyword>Sphygmocor</keyword>
  <keyword>applanation tonometry</keyword>
  <keyword>pOpmètre</keyword>
  <keyword>children</keyword>
  <keyword>EPIPAGE cohort</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Atherosclerosis</mesh_term>
    <mesh_term>Arteriosclerosis</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/NCT02991703
org study id: RC16_0161
nct id: NCT02991703
lead sponsor: 
has dmc: No
Arterial stiffness is an important marker of cardiovascular risk. It is measured by pulse
      wave velocity. The reference device to measure pulse wave velocity is the Sphygmocor which
      uses applanation tonometry. It is used in adults and children. An easier method called
      pOpmètre using saturation sensors is validated in adults but not in children. The objective
      of this study is to compare the pulse wave velocity values measured with the pOpmètre® with
      those of the SphygmoCor® to validate the pOpmètre in children between 4 and 8 years old.
Prematurity is associated with an increased risk of developing cardio-vascular diseases in
      adulthood : a low birth weight linked to prematurity is correlated to a higher coronary
      disease mortality rate, a higher blood pressure level in adulthood, to abnormal glucose
      metabolism regulation, and to signs of nephron reduction. An independent marker of
      cardiovascular risk is arterial stiffness: it is associated with a higher risk of major
      cardiovascular events including stroke, acute coronary syndrome and complications of
      end-stage renal disease. It is measured by pulse wave velocity which is the gold standard in
      adulthood. Pulse wave velocity is also correlated to cardiovascular risk in childhood.
      National cohort EPIPAGE II is made of 4290 premature babies born in 2011. A study is
      scheduled at 5 years old and a half including a medical examination and a neuropsychological
      evaluation. An ancillary study lengthening medical consultation for 15 minutes is scheduled
      with 750 to 1000 of these children for a more precise vascular evaluation including pulse
      wave velocity. Different methods can be used to measure pulse wave velocity in children:
      these include applanation tonometry devices such as the SphygmoCor ® system. Its reference
      values are well known in adulthood and were determined more recently in childhood. It is the
      reference device but it is expensive, can be used only in expert health centres and time of
      measurement is long. In children, an easier-to-use and faster device would be more
      advantageous. The pOpmètre® uses 2 distal oxygen saturation sensors on finger and toe to
      deduce pulse wave velocity. This device has already been validated in adults. The aim of this
      study is to validate the pOpmètre in children between 4 and 8 years old. In that purpose,
      patients are installed in the supine position, at rest. The child's mensurations are
      measured. The two pOpmètre sensors are put on finger and toe. Blood pressure is measured by
      an armband on the right limb. Then another armband is put around the thigh and a tonometer is
      applied on the right carotid which allows pulse wave velocity measuring by the Sphygmocor.
      Pulse wave velocity is measured with the pOpmètre using the time delay between finger pulse
      signal and toe pulse signal. The values got with the two devices are compared using a Bland
      and Altman graph. The pOpmètre is considered to be validated if the 95% confidence interval
      of the bias is included between -0.5 m/sec and 0.5 m/sec that is about 10% of the normal
      value at that age (5.0 m/s +/-0.13).
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Difference between the two simultaneous measurements of velocity of the pulse wave by the pOpmeter® and the Sphygmocor®.
time frame: Day One
arm group label: SphygmoCor®
arm group type: Active Comparator
arm group label: pOpmètre®
arm group type: Experimental
intervention type: Device
intervention name: pOpmètre®
description: the pOpmètre® uses saturation sensors,
arm group label: pOpmètre®
intervention type: Device
intervention name: Sphygmocor
description: the Sphygmocor uses applanation tonometry
arm group label: SphygmoCor®
criteria: 
gender: All
minimum age: 4 Years
maximum age: 8 Years
healthy volunteers: No
last name: Jean-Christophe ROZE, Pr
email: jeanchristophe.roze@chu-nantes.fr
last name: Emma Allain-Launay, Dr
phone: 02 40 08 36 60
email: emma.allainlaunay@chu-nantes.fr
url: https://www.youtube.com/watch?v=4aFnQ_0_bOI
description: Related Info
url: http://www.axelife.fr/fr/index.php
description: Related Info
citation: Willum-Hansen T, Staessen JA, Torp-Pedersen C, Rasmussen S, Thijs L, Ibsen H, Jeppesen J. Prognostic value of aortic pulse wave velocity as index of arterial stiffness in the general population. Circulation. 2006 Feb 7;113(5):664-70. doi: 10.1161/CIRCULATIONAHA.105.579342.
PMID: 16461839
citation: Urbina EM, Williams RV, Alpert BS, Collins RT, Daniels SR, Hayman L, Jacobson M, Mahoney L, Mietus-Snyder M, Rocchini A, Steinberger J, McCrindle B; American Heart Association Atherosclerosis, Hypertension, and Obesity in Youth Committee of the Council on Cardiovascular Disease in the Young. Noninvasive assessment of subclinical atherosclerosis in children and adolescents: recommendations for standard assessment for clinical research: a scientific statement from the American Heart Association. Hypertension. 2009 Nov;54(5):919-50. doi: 10.1161/HYPERTENSIONAHA.109.192639. Epub 2009 Sep 3. Erratum In: Hypertension. 2010 Sep;56(3):e36.
PMID: 19729599
citation: Ancel PY, Goffinet F; EPIPAGE 2 Writing Group. EPIPAGE 2: a preterm birth cohort in France in 2011. BMC Pediatr. 2014 Apr 9;14:97. doi: 10.1186/1471-2431-14-97.
PMID: 24716860
citation: Reference Values for Arterial Stiffness' Collaboration. Determinants of pulse wave velocity in healthy people and in the presence of cardiovascular risk factors: 'establishing normal and reference values'. Eur Heart J. 2010 Oct;31(19):2338-50. doi: 10.1093/eurheartj/ehq165. Epub 2010 Jun 7.
PMID: 20530030
citation: Reusz GS, Cseprekal O, Temmar M, Kis E, Cherif AB, Thaleb A, Fekete A, Szabo AJ, Benetos A, Salvi P. Reference values of pulse wave velocity in healthy children and teenagers. Hypertension. 2010 Aug;56(2):217-24. doi: 10.1161/HYPERTENSIONAHA.110.152686. Epub 2010 Jun 21.
PMID: 20566959
citation: Curcio S, Garcia-Espinosa V, Arana M, Farro I, Chiesa P, Giachetto G, Zocalo Y, Bia D. Growing-Related Changes in Arterial Properties of Healthy Children, Adolescents, and Young Adults Nonexposed to Cardiovascular Risk Factors: Analysis of Gender-Related Differences. Int J Hypertens. 2016;2016:4982676. doi: 10.1155/2016/4982676. Epub 2016 Feb 18.
PMID: 26989504
citation: Alivon M, Vo-Duc Phuong T, Vignon V, Bozec E, Khettab H, Hanon O, Briet M, Halimi JM, Hallab M, Plichart M, Mohammedi K, Marre M, Boutouyrie P, Laurent S. A novel device for measuring arterial stiffness using finger-toe pulse wave velocity: Validation study of the pOpmetre(R). Arch Cardiovasc Dis. 2015 Apr;108(4):227-34. doi: 10.1016/j.acvd.2014.12.003. Epub 2015 Feb 11.
PMID: 25682547
responsible party type: Sponsor
mesh term: Cardiovascular Diseases
mesh term: Atherosclerosis
mesh term: Arteriosclerosis