<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/NCT02968329</url>
  </required_header>
  <id_info>
    <org_study_id>JJBV544</org_study_id>
    <nct_id>NCT02968329</nct_id>
  </id_info>
  <brief_title>Left Atrial Function in Recurrent Stroke of Unknown Cause</brief_title>
  <official_title>Left Atrial Function as Predictor of Recurrent Stroke or Paroxysmal Atrial Fibrillation in Patients With Cryptogenic Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hasselt University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Jessa Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hasselt University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Stroke is an important cause of disability and the third leading cause of death.&#xD;
&#xD;
      Approximately 30 to 40 % of all strokes are estimated to be cryptogenic (i.e. no cause can be&#xD;
      found). There have been few previous studies regarding risk stratification for stroke&#xD;
      recurrence in patients with cryptogenic stroke.&#xD;
&#xD;
      Recent studies have suggested that left atrial (LA) function is an important determinant of&#xD;
      stroke risk. However, most studies focus on volume indices and LA dimensions, we also want to&#xD;
      investigate other echocardiographic parameters. The aim of this study is to assess the&#xD;
      predictive value of left atrial function for the risk of stroke recurrence and/or atrial&#xD;
      fibrillation by transthoracic echocardiography in cryptogenic stroke patients with no proven&#xD;
      atrial fibrillation (AF) and no indication for anticoagulants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study design and population The investigators used a retrospective mono-centric case-control&#xD;
      design and analyzed all patients admitted for cerebrovascular accident (CVA) or transient&#xD;
      ischemic attack (TIA) between 2011 and 2014. The investigators searched for patients who had&#xD;
      a recurrent CVA/TIA and/or who were diagnosed with newly documented AF during the study&#xD;
      duration. Clinical, demographic and laboratory parameters were assessed. Echocardiographic&#xD;
      parameters, measured on first admission, were analyzed using EchoPAC version 112.&#xD;
&#xD;
      Statistical analysis Univariate analysis was performed for all covariates using the Cox&#xD;
      proportional hazards model. Likelihood ratio tests were used to determine significance for&#xD;
      all parameters.&#xD;
&#xD;
      If covariates were significant at the 25% significance level, they were used in the&#xD;
      multivariate model.&#xD;
&#xD;
      Multivariate analysis was performed using the Cox proportional hazards model with backward&#xD;
      elimination model selection. The Wald Chi-Square test was used to determine significance at&#xD;
      5% significance level. The program used for analysis is SAS version 9.4.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2016</start_date>
  <completion_date type="Actual">April 2017</completion_date>
  <primary_completion_date type="Actual">April 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Recurrent ischemic CVA or TIA</measure>
    <time_frame>up to four years</time_frame>
    <description>Recurrent ischemic CVA or TIA from first ischemic CVA or TIA after 31-12-2010 until date of first documented recurrence, assessed up to four years</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>'New' diagnosis of AF</measure>
    <time_frame>Up to four years</time_frame>
    <description>'New' diagnosis of AF from first ischemic CVA or TIA after 31-12-2010 until date of documented 'new' AF, assessed up to four years</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">500</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>CVA cases</arm_group_label>
    <description>patients who experienced an ischemic CVA or TIA during the study duration and experienced a recurrence.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CVA controls</arm_group_label>
    <description>patients who experienced an ischemic CVA or TIA during the study duration, but who didn't experience a recurrence.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AF cases</arm_group_label>
    <description>patients who experienced an ischemic CVA or TIA during the study duration and who got diagnosed with 'new' AF</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AF controls</arm_group_label>
    <description>patients who experienced an ischemic CVA or TIA during the study duration but who didn't get diagnosed with 'new' AF during the study duration</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with Cryptogenic Stroke&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  CVA&#xD;
&#xD;
          -  TIA&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  proven AF or atrial flutter&#xD;
&#xD;
          -  prior ablation for AF&#xD;
&#xD;
          -  valvular disease&#xD;
&#xD;
          -  artificial heart valves&#xD;
&#xD;
          -  endocarditis&#xD;
&#xD;
          -  presence of an atrial septum defect or moderate to large patent foramen ovale&#xD;
&#xD;
          -  LV akinesia&#xD;
&#xD;
          -  moderate to severe carotid stenosis&#xD;
&#xD;
          -  prior surgery for carotid artery stenosis&#xD;
&#xD;
          -  total occlusion of the internal carotid artery&#xD;
&#xD;
          -  carotid artery dissection&#xD;
&#xD;
          -  vertebral artery dissection&#xD;
&#xD;
          -  massive aortic atheromatosis&#xD;
&#xD;
          -  temporal arteritis&#xD;
&#xD;
          -  basilar artery aneurysm&#xD;
&#xD;
          -  ascending aortic aneurysm&#xD;
&#xD;
          -  subclavian steal&#xD;
&#xD;
          -  prior CVA/TIA&#xD;
&#xD;
          -  intracerebral hemorrhage&#xD;
&#xD;
          -  lacunar infarction&#xD;
&#xD;
          -  clotting disorder&#xD;
&#xD;
          -  on anticoagulants&#xD;
&#xD;
          -  CVA/TIA as a procedural complication&#xD;
&#xD;
          -  hyperthyroidism&#xD;
&#xD;
          -  patients who died in hospital after first admission for CVA/TIA&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paul Dendale, prof. dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jessa Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bram Verdonck, student</last_name>
    <role>Study Chair</role>
    <affiliation>Hasselt University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jens Jeurissen, student</last_name>
    <role>Study Chair</role>
    <affiliation>Hasselt University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jessa Ziekenhuis</name>
      <address>
        <city>Hasselt</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>November 13, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>August 9, 2017</last_update_submitted>
  <last_update_submitted_qc>August 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hasselt University</investigator_affiliation>
    <investigator_full_name>prof. dr. Paul Dendale</investigator_full_name>
    <investigator_title>prof. dr.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02968329
org study id: JJBV544
nct id: NCT02968329
lead sponsor: 
collaborator: 
has dmc: No
Stroke is an important cause of disability and the third leading cause of death.

      Approximately 30 to 40 % of all strokes are estimated to be cryptogenic (i.e. no cause can be
      found). There have been few previous studies regarding risk stratification for stroke
      recurrence in patients with cryptogenic stroke.

      Recent studies have suggested that left atrial (LA) function is an important determinant of
      stroke risk. However, most studies focus on volume indices and LA dimensions, we also want to
      investigate other echocardiographic parameters. The aim of this study is to assess the
      predictive value of left atrial function for the risk of stroke recurrence and/or atrial
      fibrillation by transthoracic echocardiography in cryptogenic stroke patients with no proven
      atrial fibrillation (AF) and no indication for anticoagulants.
Study design and population The investigators used a retrospective mono-centric case-control
      design and analyzed all patients admitted for cerebrovascular accident (CVA) or transient
      ischemic attack (TIA) between 2011 and 2014. The investigators searched for patients who had
      a recurrent CVA/TIA and/or who were diagnosed with newly documented AF during the study
      duration. Clinical, demographic and laboratory parameters were assessed. Echocardiographic
      parameters, measured on first admission, were analyzed using EchoPAC version 112.

      Statistical analysis Univariate analysis was performed for all covariates using the Cox
      proportional hazards model. Likelihood ratio tests were used to determine significance for
      all parameters.

      If covariates were significant at the 25% significance level, they were used in the
      multivariate model.

      Multivariate analysis was performed using the Cox proportional hazards model with backward
      elimination model selection. The Wald Chi-Square test was used to determine significance at
      5% significance level. The program used for analysis is SAS version 9.4.
observational model: Case-Control
time perspective: Retrospective
measure: Recurrent ischemic CVA or TIA
time frame: up to four years
description: Recurrent ischemic CVA or TIA from first ischemic CVA or TIA after 31-12-2010 until date of first documented recurrence, assessed up to four years
measure: 'New' diagnosis of AF
time frame: Up to four years
description: 'New' diagnosis of AF from first ischemic CVA or TIA after 31-12-2010 until date of documented 'new' AF, assessed up to four years
arm group label: CVA cases
description: patients who experienced an ischemic CVA or TIA during the study duration and experienced a recurrence.
arm group label: CVA controls
description: patients who experienced an ischemic CVA or TIA during the study duration, but who didn't experience a recurrence.
arm group label: AF cases
description: patients who experienced an ischemic CVA or TIA during the study duration and who got diagnosed with 'new' AF
arm group label: AF controls
description: patients who experienced an ischemic CVA or TIA during the study duration but who didn't get diagnosed with 'new' AF during the study duration
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Paul Dendale, prof. dr.
role: Principal Investigator
affiliation: Jessa Hospital
last name: Bram Verdonck, student
role: Study Chair
affiliation: Hasselt University
last name: Jens Jeurissen, student
role: Study Chair
affiliation: Hasselt University
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: Hasselt University
investigator full name: prof. dr. Paul Dendale
investigator title: prof. dr.
mesh term: Stroke
sharing ipd: Undecided