xml: <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/NCT06031610</url>
    </required_header>
    <id_info>
      <org_study_id>ZJPPHEC2023O（290）</org_study_id>
      <nct_id>NCT06031610</nct_id>
    </id_info>
    <brief_title>Revascularization Effect on CSVD Burden in Carotid Artery Stenosis</brief_title>
    <acronym>RECAS</acronym>
    <official_title>Revascularization Effect on CSVD Burden in Carotid Artery Stenosis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Zhejiang Provincial People's Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Zhejiang Provincial People's Hospital</source>
    <oversight_info>
      <has_dmc>Yes</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>
        RECAS is a prospective cohort of 1,000 patients with carotid artery stenosis (CAS) and&#xD;
        undergoing revascularization therapy or standard medication treatment alone. The goal of this&#xD;
        study is to validate whether CAS revascularization when compared to standard medication&#xD;
        treatment alone, can effectively reduce the progression of Cerebral small vessel disease&#xD;
        (CSVD) burden, as well as improve the severity of retinal pathologies and cognitive&#xD;
        impairment. Therefore, Patients aged ≥ 40 years have more than 50% stenosis in unilateral&#xD;
        carotid artery and sign informed consent will be recruited. In this study, patients will be&#xD;
        asked to undergo Computed Tomography Angiography (CTA)/ Digital Subtraction Angiography&#xD;
        (DSA), Computed Tomography Perfusion (CTP),multimodal Magnetic Resonance Imaging (MRI),&#xD;
        Optical Coherence Tomography Angiography (OCTA) and neuropsychological testing. Estimated&#xD;
        follow-up can be up to 10 years.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 10, 2023</start_date>
    <completion_date type="Anticipated">May 2034</completion_date>
    <primary_completion_date type="Anticipated">December 2033</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>The development of total brain small vessel disease burden in MRI</measure>
      <time_frame>baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.</time_frame>
      <description>Total brain small-vessel disease burden is used to assess the overall impact of CSVD, with a score range of 0-4 points.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Montreal Cognitive Assessment (MoCA) score</measure>
      <time_frame>baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.</time_frame>
      <description>To assess changes in cognitive function of patients.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mini-mental State Examination(MMSE) score</measure>
      <time_frame>baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.</time_frame>
      <description>To assess changes in cognitive function of patients.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood flow density</measure>
      <time_frame>baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.</time_frame>
      <description>Record blood flow density (%) of OCTA.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Vascular perfusion area</measure>
      <time_frame>baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.</time_frame>
      <description>Record vascular perfusion area (mm^2) of OCTA.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Macular fovea retinal thickness</measure>
      <time_frame>baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.</time_frame>
      <description>Record macular fovea retinal thickness (μm) of OCTA.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Retinal nerve fiber layer thickness</measure>
      <time_frame>baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.</time_frame>
      <description>Record retinal nerve fiber layer thickness (μm) of OCTA.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change of the volume of hypoperfusion (delay time&gt;3s from baseline to follow-up CTP).</measure>
      <time_frame>baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.</time_frame>
      <description>Change of the volume of delay time&gt;3s in follow-up minus the volume at baseline.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Stenosis percent</measure>
      <time_frame>baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.</time_frame>
      <description>Restenosis can be identified by CTA/DSA evaluating the percentage of lumen of vessel but can also be classified as symptomatic vs asymptomatic and/or requiring or not re-intervention.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Patients with cerebrovascular events, cardiovascular events or death</measure>
      <time_frame>baseline,1-month,3-month,6-month,and every 1 year, follow-up time up to 10 years.</time_frame>
      <description>Cerebrovascular events included ischemic stroke, transient ischemic attack (TIA), cerebral hemorrhage and cerebral hyperperfusion syndrome. Cardiovascular events included angina and myocardial infarction. Death included any reason caused death.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">1000</enrollment>
    <condition>Carotid Artery Stenosis</condition>
    <condition>Cerebral Small Vessel Diseases</condition>
    <arm_group>
      <arm_group_label>Individuals accepted CAS</arm_group_label>
      <description>Procedure: CAS and Standard medical treatment.&#xD;
  Other:&#xD;
  Neuropsychological testing.&#xD;
  Multimodal CT: included NCCT+CTP and reconstructed 4D-CTA.&#xD;
  Multimodal MRI included T1, T2-FLAIR, DWI, DTI, SWI, fMRI.&#xD;
  Optical coherence tomography angiography.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Individuals accepted standard medical treatment alone.</arm_group_label>
      <description>Procedure: Standard medical treatment alone.&#xD;
  Other:&#xD;
  Neuropsychological testing.&#xD;
  Multimodal CT: included NCCT+CTP and reconstructed 4D-CTA.&#xD;
  Multimodal MRI includedT1, FLAIR, MRA, PWI and/or ASL, DTI, DKI, SWI, fMRI.&#xD;
  Optical coherence tomography angiography.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>carotid artery stenting</intervention_name>
      <description>Patients were monitored for at least 24 h after surgery, with control for hyperperfusion syndrome, dual antiplatelet therapy was continued for 4-6 weeks, and the postoperative patients have the final residual stenosis of less than 30%, thrombolysis in Myocardial Infarction (TIMI) grade 3, and no dissection or thrombosis. Any surgery-related complications were recorded.</description>
      <arm_group_label>Individuals accepted CAS</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The research population for this study consists of patients who have been diagnosed with&#xD;
          Carotid Artery Stenosis. The inclusion criteria are: Patients aged ≥ 40 years，≥ 50%&#xD;
          stenosis in unilateral carotid artery,sign informed consent.The exclusion criteria are:&#xD;
          Previous history of major head trauma and any intracranial surgery,intracranial&#xD;
          abnormalities,extrapyramidal symptoms or mental illness which may affect neuropsychological&#xD;
          measurement,severe loss of vision, hearing, or communicative ability. The patients will be&#xD;
          recruited from Zhejiang Provincial People's Hospital in the city of Hangzhou.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients aged ≥ 40 years.&#xD;
  &#xD;
            2. ≥ 50% stenosis in unilateral carotid artery.&#xD;
  &#xD;
            3. Sign informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Previous history of major head trauma and any intracranial surgery&#xD;
  &#xD;
            2. Intracranial abnormalities, such as intracerebral hemorrhage, subarachnoid hemorrhage,&#xD;
               and other space occupying lesions&#xD;
  &#xD;
            3. Extrapyramidal symptoms or mental illness which may affect neuropsychological&#xD;
               measurement.&#xD;
  &#xD;
            4. Severe loss of vision, hearing, or communicative ability.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Sheng Zhang, M.D.</last_name>
      <phone>+8618758188313</phone>
      <email>zhangsheng@hmc.edu.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>Zhejiang Provincial People's Hospital</name>
        <address>
          <city>Hangzhou</city>
          <state>Zhejiang</state>
          <zip>310000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Sheng Zhang, MD</last_name>
        <phone>+8618758188313</phone>
        <phone_ext>0571-85893472</phone_ext>
        <email>zhangsheng@hmc.edu.cn</email>
      </contact>
      <investigator>
        <last_name>Sheng Zhang, M.D.</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Weitao Yu, B.S.Med</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <link>
      <url>https://pubmed.ncbi.nlm.nih.gov/37236211/</url>
      <description>Related Info</description>
    </link>
    <reference>
      <citation>Duering M, Biessels GJ, Brodtmann A, Chen C, Cordonnier C, de Leeuw FE, Debette S, Frayne R, Jouvent E, Rost NS, Ter Telgte A, Al-Shahi Salman R, Backes WH, Bae HJ, Brown R, Chabriat H, De Luca A, deCarli C, Dewenter A, Doubal FN, Ewers M, Field TS, Ganesh A, Greenberg S, Helmer KG, Hilal S, Jochems ACC, Jokinen H, Kuijf H, Lam BYK, Lebenberg J, MacIntosh BJ, Maillard P, Mok VCT, Pantoni L, Rudilosso S, Satizabal CL, Schirmer MD, Schmidt R, Smith C, Staals J, Thrippleton MJ, van Veluw SJ, Vemuri P, Wang Y, Werring D, Zedde M, Akinyemi RO, Del Brutto OH, Markus HS, Zhu YC, Smith EE, Dichgans M, Wardlaw JM. Neuroimaging standards for research into small vessel disease-advances since 2013. Lancet Neurol. 2023 Jul;22(7):602-618. doi: 10.1016/S1474-4422(23)00131-X. Epub 2023 May 23. Erratum In: Lancet Neurol. 2023 Sep;22(9):e10. Lancet Neurol. 2023 Sep;22(9):e10.</citation>
      <PMID>37236211</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Zhejiang Provincial People's Hospital</investigator_affiliation>
      <investigator_full_name>Sheng Zhang</investigator_full_name>
      <investigator_title>Deputy Chief Physician</investigator_title>
    </responsible_party>
    <keyword>Carotid Artery Stenosis</keyword>
    <keyword>Cerebral Small Vessel Diseases</keyword>
    <keyword>Revascularization</keyword>
    <keyword>Carotid artery stenting</keyword>
    <keyword>prospective cohort</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Carotid Stenosis</mesh_term>
      <mesh_term>Cerebral Small Vessel Diseases</mesh_term>
      <mesh_term>Constriction, Pathologic</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06031610
  org study id: ZJPPHEC2023O（290）
  nct id: NCT06031610
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  RECAS is a prospective cohort of 1,000 patients with carotid artery stenosis (CAS) and
        undergoing revascularization therapy or standard medication treatment alone. The goal of this
        study is to validate whether CAS revascularization when compared to standard medication
        treatment alone, can effectively reduce the progression of Cerebral small vessel disease
        (CSVD) burden, as well as improve the severity of retinal pathologies and cognitive
        impairment. Therefore, Patients aged ≥ 40 years have more than 50% stenosis in unilateral
        carotid artery and sign informed consent will be recruited. In this study, patients will be
        asked to undergo Computed Tomography Angiography (CTA)/ Digital Subtraction Angiography
        (DSA), Computed Tomography Perfusion (CTP),multimodal Magnetic Resonance Imaging (MRI),
        Optical Coherence Tomography Angiography (OCTA) and neuropsychological testing. Estimated
        follow-up can be up to 10 years.
  observational model: Cohort
  time perspective: Prospective
  measure: The development of total brain small vessel disease burden in MRI
  time frame: baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.
  description: Total brain small-vessel disease burden is used to assess the overall impact of CSVD, with a score range of 0-4 points.
  measure: Montreal Cognitive Assessment (MoCA) score
  time frame: baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.
  description: To assess changes in cognitive function of patients.
  measure: Mini-mental State Examination(MMSE) score
  time frame: baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.
  description: To assess changes in cognitive function of patients.
  measure: Blood flow density
  time frame: baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.
  description: Record blood flow density (%) of OCTA.
  measure: Vascular perfusion area
  time frame: baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.
  description: Record vascular perfusion area (mm^2) of OCTA.
  measure: Macular fovea retinal thickness
  time frame: baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.
  description: Record macular fovea retinal thickness (μm) of OCTA.
  measure: Retinal nerve fiber layer thickness
  time frame: baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.
  description: Record retinal nerve fiber layer thickness (μm) of OCTA.
  measure: Change of the volume of hypoperfusion (delay time>3s from baseline to follow-up CTP).
  time frame: baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.
  description: Change of the volume of delay time>3s in follow-up minus the volume at baseline.
  measure: Stenosis percent
  time frame: baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.
  description: Restenosis can be identified by CTA/DSA evaluating the percentage of lumen of vessel but can also be classified as symptomatic vs asymptomatic and/or requiring or not re-intervention.
  measure: Number of Patients with cerebrovascular events, cardiovascular events or death
  time frame: baseline,1-month,3-month,6-month,and every 1 year, follow-up time up to 10 years.
  description: Cerebrovascular events included ischemic stroke, transient ischemic attack (TIA), cerebral hemorrhage and cerebral hyperperfusion syndrome. Cardiovascular events included angina and myocardial infarction. Death included any reason caused death.
  arm group label: Individuals accepted CAS
  description: Procedure: CAS and Standard medical treatment.
  Other:
  Neuropsychological testing.
  Multimodal CT: included NCCT+CTP and reconstructed 4D-CTA.
  Multimodal MRI included T1, T2-FLAIR, DWI, DTI, SWI, fMRI.
  Optical coherence tomography angiography.
  arm group label: Individuals accepted standard medical treatment alone.
  description: Procedure: Standard medical treatment alone.
  Other:
  Neuropsychological testing.
  Multimodal CT: included NCCT+CTP and reconstructed 4D-CTA.
  Multimodal MRI includedT1, FLAIR, MRA, PWI and/or ASL, DTI, DKI, SWI, fMRI.
  Optical coherence tomography angiography.
  intervention type: Procedure
  intervention name: carotid artery stenting
  description: Patients were monitored for at least 24 h after surgery, with control for hyperperfusion syndrome, dual antiplatelet therapy was continued for 4-6 weeks, and the postoperative patients have the final residual stenosis of less than 30%, thrombolysis in Myocardial Infarction (TIMI) grade 3, and no dissection or thrombosis. Any surgery-related complications were recorded.
  arm group label: Individuals accepted CAS
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Sheng Zhang, M.D.
  phone: +8618758188313
  email: zhangsheng@hmc.edu.cn
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  country: China
  url: https://pubmed.ncbi.nlm.nih.gov/37236211/
  description: Related Info
  citation: Duering M, Biessels GJ, Brodtmann A, Chen C, Cordonnier C, de Leeuw FE, Debette S, Frayne R, Jouvent E, Rost NS, Ter Telgte A, Al-Shahi Salman R, Backes WH, Bae HJ, Brown R, Chabriat H, De Luca A, deCarli C, Dewenter A, Doubal FN, Ewers M, Field TS, Ganesh A, Greenberg S, Helmer KG, Hilal S, Jochems ACC, Jokinen H, Kuijf H, Lam BYK, Lebenberg J, MacIntosh BJ, Maillard P, Mok VCT, Pantoni L, Rudilosso S, Satizabal CL, Schirmer MD, Schmidt R, Smith C, Staals J, Thrippleton MJ, van Veluw SJ, Vemuri P, Wang Y, Werring D, Zedde M, Akinyemi RO, Del Brutto OH, Markus HS, Zhu YC, Smith EE, Dichgans M, Wardlaw JM. Neuroimaging standards for research into small vessel disease-advances since 2013. Lancet Neurol. 2023 Jul;22(7):602-618. doi: 10.1016/S1474-4422(23)00131-X. Epub 2023 May 23. Erratum In: Lancet Neurol. 2023 Sep;22(9):e10. Lancet Neurol. 2023 Sep;22(9):e10.
  PMID: 37236211
  responsible party type: Principal Investigator
  investigator affiliation: Zhejiang Provincial People's Hospital
  investigator full name: Sheng Zhang
  investigator title: Deputy Chief Physician
  mesh term: Carotid Stenosis
  mesh term: Cerebral Small Vessel Diseases
  mesh term: Constriction, Pathologic
  sharing ipd: No