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/NCT05985213</url>
    </required_header>
    <id_info>
      <org_study_id>2023-128</org_study_id>
      <nct_id>NCT05985213</nct_id>
    </id_info>
    <brief_title>Cohort Study of Inpatients and Outpatient Patients With Cerebral Small Vessel Disease</brief_title>
    <official_title>Cohort Study of Inpatients and Outpatient Patients With Cerebral Small Vessel Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Shanghai Yueyang Integrated Medicine Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Shanghai Yueyang Integrated Medicine Hospital</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>
        This cohort study involves the dynamic collection of clinical information, including serum&#xD;
        parameters , blood pressure variability, imaging data, and neuropsychological scales, in&#xD;
        patients with cerebral small vessel disease (CSVD). The study aims to summarise the clinical&#xD;
        and imaging characteristics of the CSVD population and identify novel CSVD risk factors.&#xD;
        Additionally, this study intend to uncover the mechanisms underlying the clinical and imaging&#xD;
        outcomes of CSVD. Furthermore, a multivariable prediction model for cognitive and mood&#xD;
        disorders in patients with CSVD will be established.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Research Objectives:&#xD;
  &#xD;
          1. To conduct a longitudinal study on patients with cerebral small vessel disease (CSVD)&#xD;
             and observe the dynamic evolution of their cognitive functioning, emotional disorders,&#xD;
             and other related factors.&#xD;
  &#xD;
          2. To explore and summarize the clinical and radiological characteristics of the CSVD&#xD;
             population, and identify new risk factors for CSVD.&#xD;
  &#xD;
          3. To investigate in depth the underlying mechanisms and the relationship between clinical&#xD;
             and radiological outcomes in CSVD.&#xD;
  &#xD;
          4. To establish a multifactor prediction model for cognitive and emotional disorders in&#xD;
             CSVD.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">December 1, 2020</start_date>
    <completion_date type="Anticipated">December 31, 2028</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2027</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>Cognitive state</measure>
      <time_frame>2020-12-1 to 2027-12-31</time_frame>
      <description>The cognitive function assessment based on Montreal Cognitive Assessment(MoCA) scale.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Blood pressure variability</measure>
      <time_frame>2020-12-1 to 2027-12-31</time_frame>
      <description>24-hour ambulatory blood pressure</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The development of white matter hyperintensities, microbleeds, lacunes and, perivascular spaces.</measure>
      <time_frame>2020-12-1 to 2027-12-31</time_frame>
      <description>If the fine structures are not clearly visible on the 3.0T MRI and further evaluation is needed for the clinical and therapeutic assessment of cerebral small vessel disease, the patient will be referred to undergo a 7.0T MRI examination.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">1078</enrollment>
    <condition>Cerebral Small Vessel Diseases</condition>
    <arm_group>
      <arm_group_label>CSVD patients</arm_group_label>
      <description>The neuroimaging diagnosis will follow the Standards for Reporting Vascular Changes on Neuroimaging (STRIVE) criteria established by the neuroimaging experts in 2013. The interpretation and assessment will be conducted jointly by one experienced radiologist and one experienced neurologist.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>data collection and follow-up</intervention_name>
      <description>Main measures and data collection methods:&#xD;
  Recording of baseline demographic and clinical information of the participants.&#xD;
  Multimodal magnetic resonance imaging&#xD;
  blood pressure variability.&#xD;
  neuropsychological testing&#xD;
  Blood samples collection</description>
      <arm_group_label>CSVD patients</arm_group_label>
    </intervention>
    <biospec_retention>Samples Without DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Each patient will provide 2 tubes of fasting blood.&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with CSVD&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Participants aged between 18 and 80 years, with no restriction on gender.&#xD;
  &#xD;
            2. Participants who have completed a 3.0T MRI of the head within one year at Yueyang&#xD;
               Hospital, and meet the imaging diagnostic criteria of the 2013 STRIVE guidelines.&#xD;
  &#xD;
            3. Participants who have a Modified Rankin Scale (mRS) score of 0-2 (able to perform&#xD;
               activities of daily living) at the time of the visit.&#xD;
  &#xD;
            4. Participants who are able to understand and agree to participate in the study, and&#xD;
               have signed the informed consent form.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Diagnosis of symptomatic lacunar syndrome without 6 months of onset (participants can&#xD;
               be enrolled after 6 months to avoid the impact of the acute phase).&#xD;
  &#xD;
            2. Intracranial and extracranial vascular examination confirms stenosis of the blood&#xD;
               vessel by ≥50%.&#xD;
  &#xD;
            3. Imaging data reveals intracranial space-occupying lesions.&#xD;
  &#xD;
            4. A history of other neurological or mental illnesses with a definite diagnosis of the&#xD;
               cause, including stroke (excluding lacunar infarctions), neurodegenerative diseases&#xD;
               (such as Parkinson's disease and Alzheimer's disease).&#xD;
  &#xD;
            5. Co-occurring serious illnesses, such as malignant tumors, heart failure, respiratory&#xD;
               failure, renal failure, severe liver dysfunction, severe blood system diseases, or&#xD;
               gastrointestinal bleeding.&#xD;
  &#xD;
            6. Severe impairment in vision, hearing, language function, or limb muscular weakness&#xD;
               that prevents completion of relevant tests.&#xD;
  &#xD;
            7. Women who are pregnant or breastfeeding.&#xD;
  &#xD;
            8. MRI scan contraindicated due to various reasons (such as claustrophobia).&#xD;
  &#xD;
            9. Any other reasons that prevent the collection of clinical data required for this&#xD;
               study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jia Zhou</last_name>
      <role>Principal Investigator</role>
      <affiliation>Shanghai University of Traditional Chinese Medicine</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Yajing Huo</last_name>
      <phone>+86 188 1821 1605</phone>
      <email>heej07@126.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Yan Han</last_name>
      <phone>+86 189 1751 0069</phone>
      <email>hanyan.2006@aliyun.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine</name>
        <address>
          <city>Shanghai</city>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jia Zhou</last_name>
        <email>pdzhoujia@163.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>May 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 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>Cerebral Small Vessel Diseases</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/NCT05985213
  org study id: 2023-128
  nct id: NCT05985213
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This cohort study involves the dynamic collection of clinical information, including serum
        parameters , blood pressure variability, imaging data, and neuropsychological scales, in
        patients with cerebral small vessel disease (CSVD). The study aims to summarise the clinical
        and imaging characteristics of the CSVD population and identify novel CSVD risk factors.
        Additionally, this study intend to uncover the mechanisms underlying the clinical and imaging
        outcomes of CSVD. Furthermore, a multivariable prediction model for cognitive and mood
        disorders in patients with CSVD will be established.
  Research Objectives:
  
          1. To conduct a longitudinal study on patients with cerebral small vessel disease (CSVD)
             and observe the dynamic evolution of their cognitive functioning, emotional disorders,
             and other related factors.
  
          2. To explore and summarize the clinical and radiological characteristics of the CSVD
             population, and identify new risk factors for CSVD.
  
          3. To investigate in depth the underlying mechanisms and the relationship between clinical
             and radiological outcomes in CSVD.
  
          4. To establish a multifactor prediction model for cognitive and emotional disorders in
             CSVD.
  observational model: Cohort
  time perspective: Prospective
  measure: Cognitive state
  time frame: 2020-12-1 to 2027-12-31
  description: The cognitive function assessment based on Montreal Cognitive Assessment(MoCA) scale.
  measure: Blood pressure variability
  time frame: 2020-12-1 to 2027-12-31
  description: 24-hour ambulatory blood pressure
  measure: The development of white matter hyperintensities, microbleeds, lacunes and, perivascular spaces.
  time frame: 2020-12-1 to 2027-12-31
  description: If the fine structures are not clearly visible on the 3.0T MRI and further evaluation is needed for the clinical and therapeutic assessment of cerebral small vessel disease, the patient will be referred to undergo a 7.0T MRI examination.
  arm group label: CSVD patients
  description: The neuroimaging diagnosis will follow the Standards for Reporting Vascular Changes on Neuroimaging (STRIVE) criteria established by the neuroimaging experts in 2013. The interpretation and assessment will be conducted jointly by one experienced radiologist and one experienced neurologist.
  intervention type: Other
  intervention name: data collection and follow-up
  description: Main measures and data collection methods:
  Recording of baseline demographic and clinical information of the participants.
  Multimodal magnetic resonance imaging
  blood pressure variability.
  neuropsychological testing
  Blood samples collection
  arm group label: CSVD patients
  Each patient will provide 2 tubes of fasting blood.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Jia Zhou
  role: Principal Investigator
  affiliation: Shanghai University of Traditional Chinese Medicine
  last name: Yajing Huo
  phone: +86 188 1821 1605
  email: heej07@126.com
  last name: Yan Han
  phone: +86 189 1751 0069
  email: hanyan.2006@aliyun.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Cerebral Small Vessel Diseases
  sharing ipd: No