<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/NCT02216370</url>
  </required_header>
  <id_info>
    <org_study_id>NRRXT0001</org_study_id>
    <nct_id>NCT02216370</nct_id>
  </id_info>
  <brief_title>Detection of Occult Paroxysmal AF in Cryptogenic Stroke or TIA Patients Using an Implantable Loop Recorder and Correlation With Genetic Markers.</brief_title>
  <official_title>Detection of Occult Paroxysmal Atrial Fibrillation in Cryptogenic Stroke Patients or TIA Using an Implantable Loop Recorder and Correlation With Genetic Markers.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Martin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Martin</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Atrial fibrillation (AF) is the significant risk factor of ischemic stroke with incidence&#xD;
      about 20% of all ischemic strokes. The undiagnosed AF in cryptogenic stroke patients could be&#xD;
      present but not revealed by rutinne ECG.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The subcutaneous Insertable Cardiac Monitor - Reveal® XT ICM, which provides long-term&#xD;
      monitoring ( for 3 years), in selected stroke and TIA population on the basis of age, stroke&#xD;
      etiology, and prescreening for cardiac arrhythmias helps to increase a detection of AF to&#xD;
      16.7% (range, 14.3% to 20.0%) in compare to ambulatory ECG detection of AF 6.4% (range, 5.3%&#xD;
      to 9.0%). The AF detection after stroke and TIA strategically changes the therapeutic&#xD;
      approach. In correlation with mentioned above the incidence of both specific genetic markers&#xD;
      of AF and occurance of AF in this population and healthy volunteers are interesting.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>April 2014</start_date>
  <completion_date type="Anticipated">June 2018</completion_date>
  <primary_completion_date type="Anticipated">June 2018</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Documented Atrial Fibrillation after episode of cryptogenic stroke / TIA Documented genetic mutation PITX2 and ZFHX3</measure>
    <time_frame>12 months</time_frame>
    <description>Documented Atrial Fibrillation after episode of cryptogenic stroke / TIA Documented genetic mutation PITX2 chromosome 4q25, polymorphism rs1906591,rs10033464 and ZFHX3 chromosome 16q22, polymorphism rs2106261</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to documented Atrial Fibrillation Reccurent stroke or TIA Stroke Secondary Prevention Therapy changes within 12 months Neuroimaging Changes ( brain CT/ MRI)</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Follow-up of patients with implanted ECG monitor REVEAL XT incidence of atrial fibrillation, stroke or TIA</measure>
    <time_frame>3 Years</time_frame>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">125</enrollment>
  <condition>Cryptogenic Stroke or TIA</condition>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Cryptogenic Stroke or TIA</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Volunteers</arm_group_label>
    <description>Healthy Volunteers as comparative group adjusted to investigated group by age and gender</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with stroke or TIA confirmed by neurologist within 72 hours of onset symptoms&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1. Cryptogenic stroke or TIA within 72 h of onset symptoms according to the criteria&#xD;
             for the Trial of Org 10172 in Acute Stroke Treatment (TOAST ) 2. National Institute of&#xD;
             Health Stroke scale (NIHSS ) score ≤ 15 3. Modified Rankin Scale (mRS ) score ≤ 3 4.&#xD;
             Ability and willingness of patients or their relatives or legal representatives to&#xD;
             understand study instructions both verbal and written in accordance with ICH GCP and&#xD;
             legislation applicable in the Slovak Republic&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. Known etiology of stroke or TIA 2. Untreated hyperthyreosis 3. Myocardial infarct&#xD;
             within 1 month of onset stroke or TIA 4. Coronary bypass within 1 month of onset&#xD;
             stroke or TIA 5. Valvular disease requiring urgent surgery 6. Documented atrial&#xD;
             fibrillation or flutter . 7. Patent Foramen Ovale (PFO) 8. Permanent indication to&#xD;
             oral anticoagulation therapy 9. Long-term steroid therapy &gt; 30 days 10. Participation&#xD;
             in another clinical trial oriented to experimental pharmacologic therapy .&#xD;
&#xD;
             11. Chronic inflammatory disease ( rheumatoid arthritide, IBD (Inflammatory bowel&#xD;
             diseases ), lupus, vasculitis) 12. Severe co-morbidity not likely to complete to&#xD;
             follow-up one year 13. Pregnant and breastfeeding women 14. Indication to pacemaker&#xD;
             implantation, implantable cardioverter defibrillator (ICD) or Cardiac&#xD;
             Resynchronization Therapy IPG or ICD implantation 15. Unabillity provide or unconsent&#xD;
             with requiring protocol procedures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Andrea Petrovicova, M.D.</last_name>
    <email>andrea_petrovicova@post.sk</email>
  </overall_contact>
  <location>
    <facility>
      <name>Faculty Hospital Nitra</name>
      <address>
        <city>Nitra</city>
        <zip>94901</zip>
        <country>Slovakia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Slovakia</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 11, 2014</study_first_submitted>
  <study_first_submitted_qc>August 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <last_update_submitted>August 11, 2014</last_update_submitted>
  <last_update_submitted_qc>August 11, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 13, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cryptogenic stroke /TIA</keyword>
  <keyword>Atrial Fibrillation</keyword>
  <keyword>Implantable Loop Recorder</keyword>
  <keyword>Genetic Mutation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Ischemic Stroke</mesh_term>
    <mesh_term>Atrial Fibrillation</mesh_term>
  </condition_browse>
  <!-- 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/NCT02216370
org study id: NRRXT0001
nct id: NCT02216370
lead sponsor: 
has dmc: No
Atrial fibrillation (AF) is the significant risk factor of ischemic stroke with incidence
      about 20% of all ischemic strokes. The undiagnosed AF in cryptogenic stroke patients could be
      present but not revealed by rutinne ECG.
The subcutaneous Insertable Cardiac Monitor - Reveal® XT ICM, which provides long-term
      monitoring ( for 3 years), in selected stroke and TIA population on the basis of age, stroke
      etiology, and prescreening for cardiac arrhythmias helps to increase a detection of AF to
      16.7% (range, 14.3% to 20.0%) in compare to ambulatory ECG detection of AF 6.4% (range, 5.3%
      to 9.0%). The AF detection after stroke and TIA strategically changes the therapeutic
      approach. In correlation with mentioned above the incidence of both specific genetic markers
      of AF and occurance of AF in this population and healthy volunteers are interesting.
observational model: Case-Control
time perspective: Prospective
measure: Documented Atrial Fibrillation after episode of cryptogenic stroke / TIA Documented genetic mutation PITX2 and ZFHX3
time frame: 12 months
description: Documented Atrial Fibrillation after episode of cryptogenic stroke / TIA Documented genetic mutation PITX2 chromosome 4q25, polymorphism rs1906591,rs10033464 and ZFHX3 chromosome 16q22, polymorphism rs2106261
measure: Time to documented Atrial Fibrillation Reccurent stroke or TIA Stroke Secondary Prevention Therapy changes within 12 months Neuroimaging Changes ( brain CT/ MRI)
time frame: 12 months
measure: Follow-up of patients with implanted ECG monitor REVEAL XT incidence of atrial fibrillation, stroke or TIA
time frame: 3 Years
arm group label: Cryptogenic Stroke or TIA
arm group label: Healthy Volunteers
description: Healthy Volunteers as comparative group adjusted to investigated group by age and gender
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Andrea Petrovicova, M.D.
email: andrea_petrovicova@post.sk
facility: 
status: Recruiting
country: Slovakia
responsible party type: Sponsor
mesh term: Stroke
mesh term: Ischemic Stroke
mesh term: Atrial Fibrillation