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/NCT05966389</url>
    </required_header>
    <id_info>
      <org_study_id>2023-6-21-8</org_study_id>
      <nct_id>NCT05966389</nct_id>
    </id_info>
    <brief_title>Functional MRI to Assess Brain Damage in Cardiac Arrest Patients</brief_title>
    <official_title>Assessment of Cerebral Microcirculation, Blood-brain Barrier, and Cerebral Oxygenation Damage in Patients With Cardiac Arrest Using Functional MRI</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Capital Medical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Capital Medical University</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>
        This is a single-center, observational study. Patients after successful cardiopulmonary&#xD;
        resuscitation (CPR) will be transferred to the emergency intensive care unit for further&#xD;
        standardized management. After successful return of spontaneous circulation (ROSC) for 72h&#xD;
        and hemodynamics remained stable for 24h, the post-resuscitated patients underwent functional&#xD;
        magnetic resonance imaging (fMRI) examination. During the examination, the supervising&#xD;
        physician accompanied the patient and monitored the patient's vital signs using a magnetic&#xD;
        resonance monitoring system (Siemens Healthcare Prism, Germany). Patients who are on&#xD;
        ventilators are mechanically ventilated using a magnetic ventilator (HAMILTON-MRI, USA). In&#xD;
        additional to conventional sequences, fMRI is performed for diffusion-prepared&#xD;
        pseudo-continuous arterial spin labeling (DP-pCASL) and blood oxygenation level dependent&#xD;
        functional magnetic resonance imaging (BOLD-fMRI). These MRI sequences allow quantitative&#xD;
        assessment of the patients' cerebral microcirculation, blood-brain barrier, and cerebral&#xD;
        oxygenation status. Patients will be followed up for neurologic prognosis according to the&#xD;
        Modified Rankin Scale (mRS) at 6 months after disease onset.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 1, 2021</start_date>
    <completion_date type="Anticipated">January 2024</completion_date>
    <primary_completion_date type="Anticipated">December 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>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Neurologic prognosis</measure>
      <time_frame>6 months</time_frame>
      <description>Patients will be followed up for neurologic prognosis according to the Modified Rankin Scale (mRS) at 6 months after disease onset.</description>
    </primary_outcome>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Cardiac Arrest</condition>
    <condition>Brain Injuries</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>No interventions</intervention_name>
      <description>No interventions</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients after successful cardiopulmonary resuscitation (CPR) were transferred to the&#xD;
          emergency intensive care unit for further standardized management.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  age ≥18 years.&#xD;
  &#xD;
            -  sustained hemodynamic stability for ≥24h.&#xD;
  &#xD;
            -  the patients were unconscious and not able to obey verbal commands.&#xD;
  &#xD;
            -  Advanced life support and target temperature management within 6 hours of return of&#xD;
               spontaneous circulation (ROSC).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with hemodynamic instability.&#xD;
  &#xD;
            -  Patients who could not complete cranial MRI examination for special reasons.&#xD;
  &#xD;
            -  Patients during pregnancy.&#xD;
  &#xD;
            -  Patients who combined traumatic brain injury, stroke, cerebral hemorrhage and other&#xD;
               diseases.&#xD;
  &#xD;
            -  Patients whose family members did not agree to be enrolled.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Ziren Tang, Ph.D</last_name>
      <phone>+86 010-85231530</phone>
      <email>tangziren1970@163.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Beijing chaoyang hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100020</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Rui Shao, M.D.</last_name>
        <phone>+86 18810953685</phone>
        <email>shaorui@mail.ccmu.edu.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Capital Medical University</investigator_affiliation>
      <investigator_full_name>Tang Ziren</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Cardiac arrest</keyword>
    <keyword>functional Magnetic Resonance Imaging</keyword>
    <keyword>cerebral microcirculation</keyword>
    <keyword>blood-brain barrier</keyword>
    <keyword>cerebral oxygenation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Brain Injuries</mesh_term>
      <mesh_term>Heart Arrest</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>all IPD that underlie results in a publication</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>starting 6 months after publication</ipd_time_frame>
      <ipd_access_criteria>The de-identified survey data will be made available for research purposes by contacting the corresponding authors</ipd_access_criteria>
    </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/NCT05966389
  org study id: 2023-6-21-8
  nct id: NCT05966389
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This is a single-center, observational study. Patients after successful cardiopulmonary
        resuscitation (CPR) will be transferred to the emergency intensive care unit for further
        standardized management. After successful return of spontaneous circulation (ROSC) for 72h
        and hemodynamics remained stable for 24h, the post-resuscitated patients underwent functional
        magnetic resonance imaging (fMRI) examination. During the examination, the supervising
        physician accompanied the patient and monitored the patient's vital signs using a magnetic
        resonance monitoring system (Siemens Healthcare Prism, Germany). Patients who are on
        ventilators are mechanically ventilated using a magnetic ventilator (HAMILTON-MRI, USA). In
        additional to conventional sequences, fMRI is performed for diffusion-prepared
        pseudo-continuous arterial spin labeling (DP-pCASL) and blood oxygenation level dependent
        functional magnetic resonance imaging (BOLD-fMRI). These MRI sequences allow quantitative
        assessment of the patients' cerebral microcirculation, blood-brain barrier, and cerebral
        oxygenation status. Patients will be followed up for neurologic prognosis according to the
        Modified Rankin Scale (mRS) at 6 months after disease onset.
  observational model: Cohort
  time perspective: Prospective
  measure: Neurologic prognosis
  time frame: 6 months
  description: Patients will be followed up for neurologic prognosis according to the Modified Rankin Scale (mRS) at 6 months after disease onset.
  intervention type: Other
  intervention name: No interventions
  description: No interventions
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Ziren Tang, Ph.D
  phone: +86 010-85231530
  email: tangziren1970@163.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Capital Medical University
  investigator full name: Tang Ziren
  investigator title: Professor
  mesh term: Brain Injuries
  mesh term: Heart Arrest
  sharing ipd: Yes
  ipd description: all IPD that underlie results in a publication
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: starting 6 months after publication
  ipd access criteria: The de-identified survey data will be made available for research purposes by contacting the corresponding authors