<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/NCT04442074</url>
  </required_header>
  <id_info>
    <org_study_id>DIADOP</org_study_id>
    <nct_id>NCT04442074</nct_id>
  </id_info>
  <brief_title>Characteristics in Doppler Ultrasound of the Carotid Diaphragm Responsible for an Ischemic Stroke</brief_title>
  <acronym>DIADOP</acronym>
  <official_title>Characteristics in Doppler Ultrasound of the Carotid Diaphragm Responsible for an Ischemic Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondation Hôpital Saint-Joseph</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fondation Hôpital Saint-Joseph</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>
      Carotid diaphragms are a non-atheromatous arterial cause of cerebral infarction, especially&#xD;
      in young people (≤65 years old). This anomaly is more common in the African or&#xD;
      African-American population, although it is more and more often discovered in young&#xD;
      Caucasians. This cause of cerebrovascular accident (CVA), known until the 1970s, was later&#xD;
      forgotten until a recent revival of interest, probably in connection with the improvement of&#xD;
      imagery but also by the discovery that these lesions have a high rate of recurrence in the&#xD;
      absence of interventional care. In a Brazilian study, the carotid diaphragm was reported in&#xD;
      10% of patients under the age of 60.&#xD;
&#xD;
      The carotid diaphragm is a non-atheromatous overgrowth of the intima of the arterial wall. It&#xD;
      appears in imagery in the form of an endoluminal web wider than it is tall. Its preferred&#xD;
      seat is the carotid bulb. It is a source, by an embologenic mechanism, of cerebral infarction&#xD;
      starting from local thrombus developed within large cerebral arteries. In histology, the&#xD;
      lesions are different from atherosclerosis and characterized by a thickening of the intima&#xD;
      with proliferation of loose and strewed spindle cells mainly involving the intima.&#xD;
&#xD;
      An atheromatous plaque or dissection with detachment of the intima are the two main&#xD;
      differential diagnoses of the carotid web. However, the appearance of a diaphragm implanted&#xD;
      on a regular wall and the absence of any other localization of atheroma distinguish the&#xD;
      lesion of the carotid web from that of a focal atheromatous plate. In addition, the very&#xD;
      proximal localization of the carotid web, from the emergence of the internal carotid artery,&#xD;
      does not suggest a dissection, the localization of which is usually downstream of the bulb.&#xD;
&#xD;
      The baseline exam to detect a carotid diaphragm is a carotid angiography scan, but the&#xD;
      abnormalities are often inconspicuous, making diagnosis difficult. We can be led in case of&#xD;
      doubt to perform a conventional arteriography, which remains the &quot;gold standard&quot;. The latter,&#xD;
      dynamic examination compared to the CT scan, shows above all a stasis of blood flow in the&#xD;
      recess created by the diaphragm, stasis at the origin of the formation of thrombi. It has&#xD;
      been suspected that the maximum risk of infarction is upon waking, at the time of&#xD;
      verticalization, with mobilization of the thrombus.&#xD;
&#xD;
      Therapeutically, the discovery of a symptomatic carotid diaphragm (ischemic swallowing&#xD;
      accident) justifies radical treatment. The risk of recurrence of a patient on antithrombotic&#xD;
      (antiplatelet or anticoagulant) being too high, it is proposed either surgery, or carotid&#xD;
      angioplasty with stent placement. No comparative study of the 2 techniques has been carried&#xD;
      out.&#xD;
&#xD;
      Besides radiological examinations, ultrasound is another technique for studying the cervical&#xD;
      arteries. It is reputed to be of little contribution in the search for a carotid diaphragm,&#xD;
      but few publications exist to date even though the cervical Doppler is often the first&#xD;
      arterial examination carried out after an ischemic stroke. Two series reported Doppler&#xD;
      ultrasound data in the carotid diaphragm. A recent retrospective study evaluated, in&#xD;
      multimodal imaging [Doppler, CT scan of the Supra-Aortic Trunks (ASD) and conventional&#xD;
      arteriography], 30 patients (60 carotids) with diaphragm or atherosclerosis. The correlation&#xD;
      between conventional arteriography and CT angiography was perfect, but the correlation&#xD;
      between Doppler and CT angiography for diaphragm diagnosis was moderate. In another series&#xD;
      studying 15 diaphragms diagnosed by CT angiography, the retrospective analysis of doppler&#xD;
      reports revealed that 40% were considered normal and 60% mentioned nonspecific hyperechoic&#xD;
      lesions, but this work remained in the form of a presentation. at a congress. With the&#xD;
      improvement of the technique and the resolution of the Doppler ultrasound as well as the&#xD;
      knowledge of the particular ultrasound characteristics, it seems to us that this examination&#xD;
      could regain a place in the diagnosis of the pathology. The carotid diaphragm is also largely&#xD;
      unknown to vascular doctors practicing cervical Doppler ultrasound.&#xD;
&#xD;
      This descriptive study of the diagnostic contribution of the echo-doppler for a carotid&#xD;
      diaphragm has for perspective the establishment of a prospective study of the contribution of&#xD;
      a combined expertise angiologist-neurologist in the echo-Doppler for patients &lt;60 years&#xD;
      hospitalized for an ischemic stroke.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 13, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Doppler ultrasound sensitivity for the carotid diaphragm</measure>
    <time_frame>Day 1</time_frame>
    <description>This outcome corresponds to the number of echo-doppler reports for which the diagnosis of carotid diaphragm is mentioned, correlated to the number of echo-doppler images presenting anomalies suggestive of carotid diaphragm.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Description of Anomalies suggestive of carotid diaphragm on Doppler ultrasound</measure>
    <time_frame>Day 1</time_frame>
    <description>This outcome corresponds to the description of the evocative anomalies visualized in echo-dopple (visualization of an intimal spur, of an associated thrombus, of a morphological / hemodynamic stenosis, of turbulence of the flow).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensitivity of the Doppler ultrasound with that of the reference vascular examinations</measure>
    <time_frame>Day 1</time_frame>
    <description>This outcome corresponds to to the comparison of the number of patients with a diagnosis of carotid diaphragm according to the examination carried out using the review of the additional imagery carried out and the anatomopathological result when this was carried out.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">15</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Stroke Patients</arm_group_label>
    <description>These patients were hospitalized in the neurology / neurovascular department of the Paris Saint-Joseph Hospital Group, for the management of a transient ischemic infarction or accident for which the diagnosis of ipsilateral carotid diaphragm was accepted, between April 2017 and April 2020.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients were hospitalized in the neurology / neurovascular department of the Paris&#xD;
        Saint-Joseph Hospital Group, for the management of a transient ischemic infarction or&#xD;
        accident for which the diagnosis of ipsilateral carotid diaphragm was accepted, between&#xD;
        April 2017 and April 2020.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient whose age is&gt; 18 years old and ≤65 years old&#xD;
&#xD;
          -  Patients treated in the neurology department for an infarction or transient ischemic&#xD;
             attack for which the diagnosis of ipsilateral carotid diaphragm was accepted, between&#xD;
             April 2017 and April 2020&#xD;
&#xD;
          -  French speaking patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient under guardianship or curatorship&#xD;
&#xD;
          -  Patient deprived of liberty&#xD;
&#xD;
          -  Patient objecting to the use of his data for this research&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ruben Tamazyan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fondation Hôpital Saint-Joseph</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ruben Tamazyan, MD</last_name>
    <phone>0144128794</phone>
    <phone_ext>+33</phone_ext>
    <email>rtamazyan@hpsj.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Helene BEAUSSIER, PharmD, pHD</last_name>
    <phone>0144127883</phone>
    <phone_ext>+33</phone_ext>
    <email>hbeaussier@hpsj.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Groupe Hospitalier Paris Saint-Joseph</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ruben TAMAZYAN, MD</last_name>
      <phone>0144128794</phone>
      <phone_ext>+33</phone_ext>
      <email>rtamazyan@hpsj.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <results_reference>
    <citation>Haussen DC, Grossberg JA, Bouslama M, Pradilla G, Belagaje S, Bianchi N, Allen JW, Frankel M, Nogueira RG. Carotid Web (Intimal Fibromuscular Dysplasia) Has High Stroke Recurrence Risk and Is Amenable to Stenting. Stroke. 2017 Nov;48(11):3134-3137. doi: 10.1161/STROKEAHA.117.019020. Epub 2017 Oct 10.</citation>
    <PMID>29018133</PMID>
  </results_reference>
  <results_reference>
    <citation>Coutinho JM, Derkatch S, Potvin AR, Tomlinson G, Casaubon LK, Silver FL, Mandell DM. Carotid artery web and ischemic stroke: A case-control study. Neurology. 2017 Jan 3;88(1):65-69. doi: 10.1212/WNL.0000000000003464. Epub 2016 Nov 18. Erratum In: Neurology. 2017 Aug 1;89(5):521.</citation>
    <PMID>27864523</PMID>
  </results_reference>
  <results_reference>
    <citation>Madaelil TP, Grossberg JA, Nogueira RG, Anderson A, Barreira C, Frankel M, Haussen DC. Multimodality Imaging in Carotid Web. Front Neurol. 2019 Mar 12;10:220. doi: 10.3389/fneur.2019.00220. eCollection 2019.</citation>
    <PMID>30915028</PMID>
  </results_reference>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>April 26, 2023</last_update_submitted>
  <last_update_submitted_qc>April 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Ischemic Stroke</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/NCT04442074
org study id: DIADOP
nct id: NCT04442074
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Carotid diaphragms are a non-atheromatous arterial cause of cerebral infarction, especially
      in young people (≤65 years old). This anomaly is more common in the African or
      African-American population, although it is more and more often discovered in young
      Caucasians. This cause of cerebrovascular accident (CVA), known until the 1970s, was later
      forgotten until a recent revival of interest, probably in connection with the improvement of
      imagery but also by the discovery that these lesions have a high rate of recurrence in the
      absence of interventional care. In a Brazilian study, the carotid diaphragm was reported in
      10% of patients under the age of 60.

      The carotid diaphragm is a non-atheromatous overgrowth of the intima of the arterial wall. It
      appears in imagery in the form of an endoluminal web wider than it is tall. Its preferred
      seat is the carotid bulb. It is a source, by an embologenic mechanism, of cerebral infarction
      starting from local thrombus developed within large cerebral arteries. In histology, the
      lesions are different from atherosclerosis and characterized by a thickening of the intima
      with proliferation of loose and strewed spindle cells mainly involving the intima.

      An atheromatous plaque or dissection with detachment of the intima are the two main
      differential diagnoses of the carotid web. However, the appearance of a diaphragm implanted
      on a regular wall and the absence of any other localization of atheroma distinguish the
      lesion of the carotid web from that of a focal atheromatous plate. In addition, the very
      proximal localization of the carotid web, from the emergence of the internal carotid artery,
      does not suggest a dissection, the localization of which is usually downstream of the bulb.

      The baseline exam to detect a carotid diaphragm is a carotid angiography scan, but the
      abnormalities are often inconspicuous, making diagnosis difficult. We can be led in case of
      doubt to perform a conventional arteriography, which remains the "gold standard". The latter,
      dynamic examination compared to the CT scan, shows above all a stasis of blood flow in the
      recess created by the diaphragm, stasis at the origin of the formation of thrombi. It has
      been suspected that the maximum risk of infarction is upon waking, at the time of
      verticalization, with mobilization of the thrombus.

      Therapeutically, the discovery of a symptomatic carotid diaphragm (ischemic swallowing
      accident) justifies radical treatment. The risk of recurrence of a patient on antithrombotic
      (antiplatelet or anticoagulant) being too high, it is proposed either surgery, or carotid
      angioplasty with stent placement. No comparative study of the 2 techniques has been carried
      out.

      Besides radiological examinations, ultrasound is another technique for studying the cervical
      arteries. It is reputed to be of little contribution in the search for a carotid diaphragm,
      but few publications exist to date even though the cervical Doppler is often the first
      arterial examination carried out after an ischemic stroke. Two series reported Doppler
      ultrasound data in the carotid diaphragm. A recent retrospective study evaluated, in
      multimodal imaging [Doppler, CT scan of the Supra-Aortic Trunks (ASD) and conventional
      arteriography], 30 patients (60 carotids) with diaphragm or atherosclerosis. The correlation
      between conventional arteriography and CT angiography was perfect, but the correlation
      between Doppler and CT angiography for diaphragm diagnosis was moderate. In another series
      studying 15 diaphragms diagnosed by CT angiography, the retrospective analysis of doppler
      reports revealed that 40% were considered normal and 60% mentioned nonspecific hyperechoic
      lesions, but this work remained in the form of a presentation. at a congress. With the
      improvement of the technique and the resolution of the Doppler ultrasound as well as the
      knowledge of the particular ultrasound characteristics, it seems to us that this examination
      could regain a place in the diagnosis of the pathology. The carotid diaphragm is also largely
      unknown to vascular doctors practicing cervical Doppler ultrasound.

      This descriptive study of the diagnostic contribution of the echo-doppler for a carotid
      diaphragm has for perspective the establishment of a prospective study of the contribution of
      a combined expertise angiologist-neurologist in the echo-Doppler for patients <60 years
      hospitalized for an ischemic stroke.
observational model: Cohort
time perspective: Retrospective
measure: Doppler ultrasound sensitivity for the carotid diaphragm
time frame: Day 1
description: This outcome corresponds to the number of echo-doppler reports for which the diagnosis of carotid diaphragm is mentioned, correlated to the number of echo-doppler images presenting anomalies suggestive of carotid diaphragm.
measure: Description of Anomalies suggestive of carotid diaphragm on Doppler ultrasound
time frame: Day 1
description: This outcome corresponds to the description of the evocative anomalies visualized in echo-dopple (visualization of an intimal spur, of an associated thrombus, of a morphological / hemodynamic stenosis, of turbulence of the flow).
measure: Sensitivity of the Doppler ultrasound with that of the reference vascular examinations
time frame: Day 1
description: This outcome corresponds to to the comparison of the number of patients with a diagnosis of carotid diaphragm according to the examination carried out using the review of the additional imagery carried out and the anatomopathological result when this was carried out.
arm group label: Stroke Patients
description: These patients were hospitalized in the neurology / neurovascular department of the Paris Saint-Joseph Hospital Group, for the management of a transient ischemic infarction or accident for which the diagnosis of ipsilateral carotid diaphragm was accepted, between April 2017 and April 2020.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Ruben Tamazyan, MD
role: Principal Investigator
affiliation: Fondation Hôpital Saint-Joseph
last name: Ruben Tamazyan, MD
phone: 0144128794
phone ext: +33
email: rtamazyan@hpsj.fr
last name: Helene BEAUSSIER, PharmD, pHD
phone: 0144127883
phone ext: +33
email: hbeaussier@hpsj.fr
facility: 
status: Recruiting
contact: 
country: France
citation: Haussen DC, Grossberg JA, Bouslama M, Pradilla G, Belagaje S, Bianchi N, Allen JW, Frankel M, Nogueira RG. Carotid Web (Intimal Fibromuscular Dysplasia) Has High Stroke Recurrence Risk and Is Amenable to Stenting. Stroke. 2017 Nov;48(11):3134-3137. doi: 10.1161/STROKEAHA.117.019020. Epub 2017 Oct 10.
PMID: 29018133
citation: Coutinho JM, Derkatch S, Potvin AR, Tomlinson G, Casaubon LK, Silver FL, Mandell DM. Carotid artery web and ischemic stroke: A case-control study. Neurology. 2017 Jan 3;88(1):65-69. doi: 10.1212/WNL.0000000000003464. Epub 2016 Nov 18. Erratum In: Neurology. 2017 Aug 1;89(5):521.
PMID: 27864523
citation: Madaelil TP, Grossberg JA, Nogueira RG, Anderson A, Barreira C, Frankel M, Haussen DC. Multimodality Imaging in Carotid Web. Front Neurol. 2019 Mar 12;10:220. doi: 10.3389/fneur.2019.00220. eCollection 2019.
PMID: 30915028
responsible party type: Sponsor
mesh term: Stroke
mesh term: Ischemic Stroke