<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/NCT03252652</url>
  </required_header>
  <id_info>
    <org_study_id>SNPCUETCDE</org_study_id>
    <nct_id>NCT03252652</nct_id>
  </id_info>
  <brief_title>Normal Parameters of Cranial Vessels Using Cranial Vascular Duplex Among Egyptian Population</brief_title>
  <official_title>Standardization of Normal Parameters of Cranial Vessels by Using Extra and Trans Cranial Vascular Duplex Among Egyptian Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</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 study will be carried out to standardize normal parameters of vascular duplex ultrasound&#xD;
      of the cranial vessels in the Egyptian population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Atherosclerosis is a major cause of ischemic stroke and a significant proportion of strokes&#xD;
      are thromboembolic in nature, arising from atherosclerotic plaques. Several studies have&#xD;
      reported racial differences in the severity and distribution of carotid atherosclerosis. In&#xD;
      the United States and Western communities, Extra-cranial carotid artery disease was estimated&#xD;
      to be responsible for 20-30% of strokes. Little is known about the prevalence and&#xD;
      distribution of carotid disease among the populations in the developing countries.&#xD;
&#xD;
      Vascular duplex ultrasound is a useful, cheap and available diagnostic tool for assessing&#xD;
      cranial vascular disease. Duplex ultrasound can be highly reliable with proper technique,&#xD;
      without the risk of radiation in other imaging modalities, is well tolerated by all patients&#xD;
      including those who are claustrophobic in MRI machines, and has much less risks compared to&#xD;
      conventional angiography studies.&#xD;
&#xD;
      Although vascular duplex has been used for years yet there is little researches had been done&#xD;
      on normal population in the developing countries to collect results and compare it to the&#xD;
      parameters that was collected and reviewed in the western developed populations.&#xD;
&#xD;
      The parameters that would be used in this study include both the data collected by static and&#xD;
      dynamic duplex scan which are the intimal-medial thickness, the vessels' diameter, peak flow&#xD;
      velocity and peak flow volume both systolic and diastolic for either extra- or intra-cranial&#xD;
      vessels.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 2017</start_date>
  <completion_date type="Anticipated">October 2019</completion_date>
  <primary_completion_date type="Anticipated">August 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Normal intimal-medial thickness measured in millimeter</measure>
    <time_frame>24 months</time_frame>
    <description>Estimation of the intimal-medial thickness for cranial vessels.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Normal vessels' diameter measured in millimeter</measure>
    <time_frame>24 months</time_frame>
    <description>Estimation of the vessels' diameter</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Normal peak flow velocity measured in cm/sec</measure>
    <time_frame>24 months</time_frame>
    <description>peak flow velocity both systolic and diastolic for cranial vessels</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Normal indices</measure>
    <time_frame>24 months</time_frame>
    <description>pulsatility index and resistance index for cranial vessels</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Early detection of subjects at risk of atherosclerosis</measure>
    <time_frame>24 months</time_frame>
    <description>detection of subjects with early atherosclerotic changes for further management</description>
  </secondary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Atherosclerosis</condition>
  <condition>Atheroma of Cerebral Arteries</condition>
  <condition>Atheroma; Carotid Artery</condition>
  <condition>Atheroma; Cerebral</condition>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>vascular duplex ultrasound imaging</intervention_name>
    <description>Duplex ultrasound is a non-invasive evaluation of blood flow through cranial arteries and veins.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Egyptian population&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Normal subjects between 20-40 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diabetic patients, hypertensive patients, any evidence of vascular disease either&#xD;
             peripheral or central, subjects refusing to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mostafa H Ghazally, MBChB</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Tarek A Rageh, PHD</last_name>
    <phone>+0201223849203</phone>
    <email>Tarek_rageh@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Khaled O Abosheira, PHD</last_name>
    <phone>+0201003012229</phone>
  </overall_contact_backup>
  <reference>
    <citation>Yadav JS, Wholey MH, Kuntz RE, Fayad P, Katzen BT, Mishkel GJ, Bajwa TK, Whitlow P, Strickman NE, Jaff MR, Popma JJ, Snead DB, Cutlip DE, Firth BG, Ouriel K; Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy Investigators. Protected carotid-artery stenting versus endarterectomy in high-risk patients. N Engl J Med. 2004 Oct 7;351(15):1493-501. doi: 10.1056/NEJMoa040127.</citation>
    <PMID>15470212</PMID>
  </reference>
  <reference>
    <citation>Grau AJ, Weimar C, Buggle F, Heinrich A, Goertler M, Neumaier S, Glahn J, Brandt T, Hacke W, Diener HC. Risk factors, outcome, and treatment in subtypes of ischemic stroke: the German stroke data bank. Stroke. 2001 Nov;32(11):2559-66. doi: 10.1161/hs1101.098524.</citation>
    <PMID>11692017</PMID>
  </reference>
  <reference>
    <citation>Timsit SG, Sacco RL, Mohr JP, Foulkes MA, Tatemichi TK, Wolf PA, Price TR, Hier DB. Early clinical differentiation of cerebral infarction from severe atherosclerotic stenosis and cardioembolism. Stroke. 1992 Apr;23(4):486-91. doi: 10.1161/01.str.23.4.486.</citation>
    <PMID>1561677</PMID>
  </reference>
  <reference>
    <citation>Svicero DJ, Doiche DP, Mamprim MJ, Heckler MC, Amorim RM. Ultrasound evaluation of common carotid artery blood flow in the Labrador retriever. BMC Vet Res. 2013 Oct 7;9:195. doi: 10.1186/1746-6148-9-195.</citation>
    <PMID>24094043</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>August 16, 2017</last_update_submitted>
  <last_update_submitted_qc>August 16, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Mostafa Mohammed Hamdy Ghazally</investigator_full_name>
    <investigator_title>principle investigator</investigator_title>
  </responsible_party>
  <keyword>Cranial vessels</keyword>
  <keyword>Normal parameters</keyword>
  <keyword>Carotid Duplex</keyword>
  <keyword>Egyptian</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atherosclerosis</mesh_term>
    <mesh_term>Plaque, Atherosclerotic</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/NCT03252652
org study id: SNPCUETCDE
nct id: NCT03252652
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
the study will be carried out to standardize normal parameters of vascular duplex ultrasound
      of the cranial vessels in the Egyptian population.
Atherosclerosis is a major cause of ischemic stroke and a significant proportion of strokes
      are thromboembolic in nature, arising from atherosclerotic plaques. Several studies have
      reported racial differences in the severity and distribution of carotid atherosclerosis. In
      the United States and Western communities, Extra-cranial carotid artery disease was estimated
      to be responsible for 20-30% of strokes. Little is known about the prevalence and
      distribution of carotid disease among the populations in the developing countries.

      Vascular duplex ultrasound is a useful, cheap and available diagnostic tool for assessing
      cranial vascular disease. Duplex ultrasound can be highly reliable with proper technique,
      without the risk of radiation in other imaging modalities, is well tolerated by all patients
      including those who are claustrophobic in MRI machines, and has much less risks compared to
      conventional angiography studies.

      Although vascular duplex has been used for years yet there is little researches had been done
      on normal population in the developing countries to collect results and compare it to the
      parameters that was collected and reviewed in the western developed populations.

      The parameters that would be used in this study include both the data collected by static and
      dynamic duplex scan which are the intimal-medial thickness, the vessels' diameter, peak flow
      velocity and peak flow volume both systolic and diastolic for either extra- or intra-cranial
      vessels.
observational model: Other
time perspective: Cross-Sectional
measure: Normal intimal-medial thickness measured in millimeter
time frame: 24 months
description: Estimation of the intimal-medial thickness for cranial vessels.
measure: Normal vessels' diameter measured in millimeter
time frame: 24 months
description: Estimation of the vessels' diameter
measure: Normal peak flow velocity measured in cm/sec
time frame: 24 months
description: peak flow velocity both systolic and diastolic for cranial vessels
measure: Normal indices
time frame: 24 months
description: pulsatility index and resistance index for cranial vessels
measure: Early detection of subjects at risk of atherosclerosis
time frame: 24 months
description: detection of subjects with early atherosclerotic changes for further management
intervention type: Radiation
intervention name: vascular duplex ultrasound imaging
description: Duplex ultrasound is a non-invasive evaluation of blood flow through cranial arteries and veins.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mostafa H Ghazally, MBChB
role: Principal Investigator
affiliation: Assiut University
last name: Tarek A Rageh, PHD
phone: +0201223849203
email: Tarek_rageh@hotmail.com
last name: Khaled O Abosheira, PHD
phone: +0201003012229
citation: Yadav JS, Wholey MH, Kuntz RE, Fayad P, Katzen BT, Mishkel GJ, Bajwa TK, Whitlow P, Strickman NE, Jaff MR, Popma JJ, Snead DB, Cutlip DE, Firth BG, Ouriel K; Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy Investigators. Protected carotid-artery stenting versus endarterectomy in high-risk patients. N Engl J Med. 2004 Oct 7;351(15):1493-501. doi: 10.1056/NEJMoa040127.
PMID: 15470212
citation: Grau AJ, Weimar C, Buggle F, Heinrich A, Goertler M, Neumaier S, Glahn J, Brandt T, Hacke W, Diener HC. Risk factors, outcome, and treatment in subtypes of ischemic stroke: the German stroke data bank. Stroke. 2001 Nov;32(11):2559-66. doi: 10.1161/hs1101.098524.
PMID: 11692017
citation: Timsit SG, Sacco RL, Mohr JP, Foulkes MA, Tatemichi TK, Wolf PA, Price TR, Hier DB. Early clinical differentiation of cerebral infarction from severe atherosclerotic stenosis and cardioembolism. Stroke. 1992 Apr;23(4):486-91. doi: 10.1161/01.str.23.4.486.
PMID: 1561677
citation: Svicero DJ, Doiche DP, Mamprim MJ, Heckler MC, Amorim RM. Ultrasound evaluation of common carotid artery blood flow in the Labrador retriever. BMC Vet Res. 2013 Oct 7;9:195. doi: 10.1186/1746-6148-9-195.
PMID: 24094043
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Mostafa Mohammed Hamdy Ghazally
investigator title: principle investigator
mesh term: Atherosclerosis
mesh term: Plaque, Atherosclerotic