<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/NCT03816865</url>
  </required_header>
  <id_info>
    <org_study_id>NOR-FIB2</org_study_id>
    <nct_id>NCT03816865</nct_id>
  </id_info>
  <brief_title>Fibrosis, Inflammation and Brain Health in Atrial Fibrillation.</brief_title>
  <acronym>NOR-FIB2</acronym>
  <official_title>Fibrosis, Inflammation and Brain Health in Atrial Fibrillation. The Norwegian Atrial Fibrillation and Stroke Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oslo University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ostfold Hospital Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Oslo University 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>
      Protocol synopsis Sponsor: Oslo University Hospital Title: Fibrosis, inflammation and&#xD;
      cerebral infarction in patients with atrial fibrillation Study Design: The study is an&#xD;
      observational prospective study of atrial fibrillation patients undergoing direct-current&#xD;
      cardioversion.&#xD;
&#xD;
      Primary Objective: To assess the prevalence and causes of new silent cerebral ischemic&#xD;
      lesions after programmed direct-current cardioversion using diffusion-weighted sequences in&#xD;
      brain MRI (DWMRI).&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
      To study the impact of inflammation measured by biomarkers and cardiac 18F-FDG-PET on the&#xD;
      risk for new silent cerebral ischemic lesions after direct-current cardioversion for AF.&#xD;
&#xD;
      To assess the impact of fibrosis measured by biomarkers on the risk for new silent cerebral&#xD;
      ischemic lesions after direct-current cardioversion for AF.&#xD;
&#xD;
      To assess cognitive and cerebral structural and metabolic changes after direct-current&#xD;
      cardioversion for AF using cognitive assessments and cerebral and cardiac 18F-FDG-PET before&#xD;
      and 12 months after treatment.&#xD;
&#xD;
      Number of Subjects: 50&#xD;
&#xD;
      Study Centers: Østfold Hospital Trust&#xD;
&#xD;
      Duration of Study Participation:&#xD;
&#xD;
        -  Enrollment: 18 months&#xD;
&#xD;
        -  Follow-up period: 12 months&#xD;
&#xD;
        -  Total Study Duration: 30 months&#xD;
&#xD;
      Primary Endpoints:&#xD;
&#xD;
      • Number of new small cerebral infarcts detected with DWMRI two weeks after direct current&#xD;
      cardioversion.&#xD;
&#xD;
      Secondary Endpoints:&#xD;
&#xD;
        -  Rate of AF recurrence within 1 year after direct current cardioversion&#xD;
&#xD;
        -  Change in levels of inflammation biomarkersfrom baseline to 12 months follow-up&#xD;
&#xD;
        -  Change in levels of fibrosis biomarkers from baseline to 12 months follow-up&#xD;
&#xD;
        -  Cognitive function at 12 months follow-up&#xD;
&#xD;
        -  Changes in uptake pattern on cerebral 18F-FDG-PET from baseline to 12 months follow-up&#xD;
&#xD;
        -  Changes in uptake pattern on cardiac 18F-FDG-PET from baseline to 12 months follow-up&#xD;
&#xD;
        -  Brain volume at 12 months follow-up&#xD;
&#xD;
        -  White matter volume 12 months follow-up&#xD;
&#xD;
        -  Grey matter volume 12 months follow-up&#xD;
&#xD;
        -  Cortical volume 12 months follow-up&#xD;
&#xD;
        -  RSI-derived diffusion parameters 12 months follow-up: fast apparent diffusion&#xD;
           coefficient, extracellular water fraction, fractional anisotropy; free water fraction;&#xD;
           intracranial volume; NAWM: normal appearing white matter; neurite density; RSI:&#xD;
           restriction spectrum imaging; sADC: slow apparent diffusion coefficient;restricted&#xD;
           fractional anisotropy; white matter lesions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 1, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</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>Number of new small cerebral infarcts detected with DWMRI two weeks after direct current cardioversion.</measure>
    <time_frame>2 weeks</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Atrial Fibrillation</condition>
  <condition>Stroke</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with atrial fibrillation undergoing direct-current cardioversion&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        1. Known atrial fibrillation&#xD;
&#xD;
          2. Age &lt;80 years&#xD;
&#xD;
          3. CHA2DS2-VASc ≤ 4&#xD;
&#xD;
          4. Planned direct-current cardioversion&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. CHA2DS2-VASc &gt;4&#xD;
&#xD;
          2. Life expectancy less than 1 year&#xD;
&#xD;
          3. Patient otherwise not eligible for the study or adherent for follow-up (eg&#xD;
             nonresident) or has concurrent disease affecting outcome (e.g. multiple sclerosis,&#xD;
             cancer)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>Anne Hege Aamodt, MD, PhD</last_name>
    <phone>+47 95867270</phone>
    <email>anhaam@ous-hf.no</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Gudrun Høie, MD</last_name>
    <phone>+47 97652459</phone>
    <email>gudrun.anette.hoie@so-hf.no</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Oslo University Hospital</name>
      <address>
        <city>Oslo</city>
        <zip>0424</zip>
        <country>Norway</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anne Hege Aamodt, MD PhD</last_name>
      <phone>+4723074976</phone>
      <email>anne.hege.aamodt@ous-hf.no</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Østfold Hospital</name>
      <address>
        <city>Sarpsborg</city>
        <country>Norway</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Peter Andel</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>January 23, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>March 2, 2021</last_update_submitted>
  <last_update_submitted_qc>March 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oslo University Hospital</investigator_affiliation>
    <investigator_full_name>Anne Hege Aamodt</investigator_full_name>
    <investigator_title>Senior Consultant in Neurology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03816865
org study id: NOR-FIB2
nct id: NCT03816865
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Protocol synopsis Sponsor: Oslo University Hospital Title: Fibrosis, inflammation and
      cerebral infarction in patients with atrial fibrillation Study Design: The study is an
      observational prospective study of atrial fibrillation patients undergoing direct-current
      cardioversion.

      Primary Objective: To assess the prevalence and causes of new silent cerebral ischemic
      lesions after programmed direct-current cardioversion using diffusion-weighted sequences in
      brain MRI (DWMRI).

      Secondary Objectives:

      To study the impact of inflammation measured by biomarkers and cardiac 18F-FDG-PET on the
      risk for new silent cerebral ischemic lesions after direct-current cardioversion for AF.

      To assess the impact of fibrosis measured by biomarkers on the risk for new silent cerebral
      ischemic lesions after direct-current cardioversion for AF.

      To assess cognitive and cerebral structural and metabolic changes after direct-current
      cardioversion for AF using cognitive assessments and cerebral and cardiac 18F-FDG-PET before
      and 12 months after treatment.

      Number of Subjects: 50

      Study Centers: Østfold Hospital Trust

      Duration of Study Participation:

        -  Enrollment: 18 months

        -  Follow-up period: 12 months

        -  Total Study Duration: 30 months

      Primary Endpoints:

      • Number of new small cerebral infarcts detected with DWMRI two weeks after direct current
      cardioversion.

      Secondary Endpoints:

        -  Rate of AF recurrence within 1 year after direct current cardioversion

        -  Change in levels of inflammation biomarkersfrom baseline to 12 months follow-up

        -  Change in levels of fibrosis biomarkers from baseline to 12 months follow-up

        -  Cognitive function at 12 months follow-up

        -  Changes in uptake pattern on cerebral 18F-FDG-PET from baseline to 12 months follow-up

        -  Changes in uptake pattern on cardiac 18F-FDG-PET from baseline to 12 months follow-up

        -  Brain volume at 12 months follow-up

        -  White matter volume 12 months follow-up

        -  Grey matter volume 12 months follow-up

        -  Cortical volume 12 months follow-up

        -  RSI-derived diffusion parameters 12 months follow-up: fast apparent diffusion
           coefficient, extracellular water fraction, fractional anisotropy; free water fraction;
           intracranial volume; NAWM: normal appearing white matter; neurite density; RSI:
           restriction spectrum imaging; sADC: slow apparent diffusion coefficient;restricted
           fractional anisotropy; white matter lesions.
observational model: Cohort
time perspective: Prospective
measure: Number of new small cerebral infarcts detected with DWMRI two weeks after direct current cardioversion.
time frame: 2 weeks
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
last name: Anne Hege Aamodt, MD, PhD
phone: +47 95867270
email: anhaam@ous-hf.no
last name: Gudrun Høie, MD
phone: +47 97652459
email: gudrun.anette.hoie@so-hf.no
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Norway
responsible party type: Principal Investigator
investigator affiliation: Oslo University Hospital
investigator full name: Anne Hege Aamodt
investigator title: Senior Consultant in Neurology
mesh term: Atrial Fibrillation
mesh term: Inflammation
sharing ipd: No