<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/NCT02232022</url>
  </required_header>
  <id_info>
    <org_study_id>14-336</org_study_id>
    <nct_id>NCT02232022</nct_id>
  </id_info>
  <brief_title>Occult Paroxysmal Atrial Fibrillation in Non-Cryptogenic Ischemic Stroke</brief_title>
  <official_title>Occult Paroxysmal Atrial Fibrillation in Non-Cryptogenic Ischemic Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwell Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Northwell Health</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the incidence of paroxysmal atrial fibrillation&#xD;
      (AF) in ischemic stroke patients who have a presumed known stroke etiology other than atrial&#xD;
      fibrillation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Recent studies suggest that their is a relatively high incidence of silent paroxysmal atrial&#xD;
      fibrillation (PAF) in cryptogenic ischemic stroke patients. Detection of silent PAF in this&#xD;
      population, however, requires prolonged cardiac monitoring. On the other hand, there is no&#xD;
      understanding of the frequency of silent PAF in patients with a &quot;known&quot; or presumed etiology&#xD;
      for their ischemic stroke other than AF. If this incidence is also found to be significant, a&#xD;
      dramatic change in stroke evaluation and management would likely occur. This study intends to&#xD;
      find the incidence of PAF in a population of recent (within 7 days) ischemic stroke patients&#xD;
      (or MRI positive &quot;transient ischemic attack (TIA)&quot; patients) who have presumed etiology for&#xD;
      their stroke other than atrial fibrillation or other high risk cardiac lesion. Stroke&#xD;
      etiology will be determined through a standard post-stroke evaluation that includes:&#xD;
&#xD;
        -  Brain MRI&#xD;
&#xD;
        -  12-lead electrocardiogram (ECG) for AF detection&#xD;
&#xD;
        -  24-h ECG monitoring for AF detection (eg, Holter monitor or cardiac telemetry)&#xD;
&#xD;
        -  Transthoracic and/or Transesophageal echocardiogram&#xD;
&#xD;
        -  CT or MR angiography of the head and neck&#xD;
&#xD;
        -  Hypercoagulable blood panel for patients less than 55 years-old. Preliminary&#xD;
           hypercoagulable work-up within 7 days will include the antiphospholipid antibody&#xD;
           syndrome results, which will be needed to determine stroke management. All other&#xD;
           results, which could take longer to return, including genetic tests of&#xD;
           hypercoagulability, rarely change stroke management.&#xD;
&#xD;
      To find occult PAF in this population, participants will have an insertable cardiac monitor&#xD;
      (Reveal LINQ ICM) implanted within 7 days of the incident stroke and will be monitored for at&#xD;
      least 1 year.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2014</start_date>
  <completion_date type="Actual">September 28, 2017</completion_date>
  <primary_completion_date type="Actual">September 28, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of Paroxysmal Atrial Fibrillation (AF) in Ischemic Stroke Patients</measure>
    <time_frame>1 year</time_frame>
    <description>The incidence of paroxysmal atrial fibrillation (AF) in ischemic stroke patients who have a presumed known stroke etiology other than atrial fibrillation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patients Who Are Diagnosed With AF Who Are Changed to Anticoagulant Therapy.</measure>
    <time_frame>1 year</time_frame>
    <description>Percentage of patients who are diagnosed with AF who are changed to anticoagulant therapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of AF Episodes.</measure>
    <time_frame>1 year</time_frame>
    <description>Duration of AF episodes (mean and range).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Asymptomatic AF</measure>
    <time_frame>1 year</time_frame>
    <description>Percentage of asymptomatic AF episodes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Recurrent Stroke</measure>
    <time_frame>1 year</time_frame>
    <description>Incidence of recurrent ischemic stroke.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients That Had Multiple AF Episodes</measure>
    <time_frame>1 year</time_frame>
    <description>Number of patients that had multiple AF episodes.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">53</enrollment>
  <condition>Ischemic Stroke</condition>
  <arm_group>
    <arm_group_label>NonCryptogenic Ischemic Stroke Patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with non-cryptogenic ischemic stroke will be enrolled within 10 days of stroke onset</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Reveal LINQ Insertable Cardiac Monitor</intervention_name>
    <arm_group_label>NonCryptogenic Ischemic Stroke Patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with a recent ischemic stroke or transient ischemic attack (TIA) with brain&#xD;
             infarction on brain imaging.&#xD;
&#xD;
          -  No history of atrial fibrillation or finding of atrial fibrillation on standard&#xD;
             inpatient monitoring (electrocardiogram, telemetry, 24-hour Holter monitor)&#xD;
&#xD;
          -  Have a presumed stroke etiology: Lacunar or small vessel thrombosis, extra-cranial or&#xD;
             intracranial atherosclerotic stenosis or dissection, arteriopathy or vasculitis,&#xD;
             hypercoagulable state, aortic arch plaque with or without mobile elements, or evidence&#xD;
             of a low-risk cardiac source (e.g., patent foramen ovale with or without atrial septal&#xD;
             aneurysm and with or without evidence of venous thromboembolic source).&#xD;
&#xD;
          -  Have virtual CHADS2 score ≥3 or&#xD;
&#xD;
          -  Have 2 or more of the following co-morbidities: obstructive sleep apnea, coronary&#xD;
             artery disease, (Chronic Pulmonary Obstructive Disease (COPD), hyperthyroidism, Body&#xD;
             Mass Index&gt; 30, prior myocardial infarction, prolonged PR interval (&gt;175 ms) or renal&#xD;
             impairment (GFR 30-60).&#xD;
&#xD;
          -  Patient or legally authorized representative who is willing to sign written consent&#xD;
             form.&#xD;
&#xD;
          -  Patient is ≥40 years old (patients younger than 40 years old have a very low&#xD;
             likelihood of having atrial fibrillation and are therefore excluded from the study).&#xD;
&#xD;
          -  Patient can have the device implanted within 7 days of the incident ischemic event&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Documented history of AF or atrial flutter.&#xD;
&#xD;
          -  Evidence of a high-risk cardiac source of embolism (Left Ventricular or Left Atrial&#xD;
             thrombus or &quot;smoke,&quot; emboligenic valvular lesion or tumor)&#xD;
&#xD;
          -  Untreated hyperthyroidism.&#xD;
&#xD;
          -  Myocardial infarction or coronary bypass grafting within 1 month prior to the&#xD;
             stroke/TIA.&#xD;
&#xD;
          -  Valvular disease requiring immediate surgical intervention.&#xD;
&#xD;
          -  Permanent indication for anticoagulation at enrollment.&#xD;
&#xD;
          -  Permanent oral anticoagulation contraindication.&#xD;
&#xD;
          -  Already included in another clinical trial that will affect the objectives of this&#xD;
             study.&#xD;
&#xD;
          -  Life expectancy is less than 1 year.&#xD;
&#xD;
          -  Pregnancy. Urine or serum pregnancy test is required for women of child bearing&#xD;
             potential to exclude pregnancy.&#xD;
&#xD;
          -  Patient is indicated for implant with a pacemaker, implantable&#xD;
             cardioverter-defibrillator, CRT device, or an implantable hemodynamic monitoring&#xD;
             system&#xD;
&#xD;
          -  Patient is not fit, or is unable or unwilling to follow the required procedures of the&#xD;
             Clinical Investigation Plan.&#xD;
&#xD;
          -  Cryptogenic Stroke: A stroke/TIA will be considered cryptogenic if no cause is&#xD;
             determined despite extensive inpatient workup according to the standard diagnostic&#xD;
             protocol at North Shore University Hospital.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>41 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeffrey M. Katz, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwell Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>North Shore University Hospital</name>
      <address>
        <city>Manhasset</city>
        <state>New York</state>
        <zip>11557</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Long Island Jewish Medical Center</name>
      <address>
        <city>New Hyde Park</city>
        <state>New York</state>
        <zip>11040</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>September 2, 2014</study_first_submitted>
  <study_first_submitted_qc>September 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 4, 2014</study_first_posted>
  <results_first_submitted>March 11, 2019</results_first_submitted>
  <results_first_submitted_qc>June 21, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">July 17, 2019</results_first_posted>
  <last_update_submitted>July 17, 2019</last_update_submitted>
  <last_update_submitted_qc>July 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwell Health</investigator_affiliation>
    <investigator_full_name>Jeffrey Katz</investigator_full_name>
    <investigator_title>Chief, Vascular Neurology</investigator_title>
  </responsible_party>
  <keyword>Stroke</keyword>
  <keyword>Ischemic stroke</keyword>
  <keyword>Atrial fibrillation</keyword>
  <keyword>Insertable cardiac monitor</keyword>
  <keyword>Non-cryptogenic</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>Cerebral Infarction</mesh_term>
    <mesh_term>Atrial Fibrillation</mesh_term>
    <mesh_term>Ischemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 16, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/22/NCT02232022/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>NonCryptogenic Ischemic Stroke Patients</title>
          <description>In this pilot prospective cohort study of non-CIS patients from September 2014 to September 2017. Patients were implanted within 10 days of stroke onset with the Reveal LINQ insertable cardiac monitor and monitored until PAF detection or a minimum of 12 months. Inclusion required diagnosis of a non-AF stroke etiology, age≥40, and either a virtual CHADS2 score ≥3 or ≥2 PAF related comorbidities.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="53"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="51"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>NonCryptogenic Ischemic Stroke Patients</title>
          <description>In this pilot prospective cohort study of non-CIS patients from September 2014 to September 2017, 53 patients were enrolled. 51/53 patients were implanted within 10 days of stroke onset with the Reveal LINQ insertable cardiac monitor and monitored until PAF detection or a minimum of 12 months.&#xD;
Inclusion required diagnosis of a non-AF stroke etiology, age≥40, and either a virtual CHADS2 score ≥3 or ≥2 PAF related comorbidities.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="53"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64.8" spread="10.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline AF Assessment</title>
          <description>Baseline AF Assessment completed using 24 hour ECG monitoring</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Incidence of Paroxysmal Atrial Fibrillation (AF) in Ischemic Stroke Patients</title>
        <description>The incidence of paroxysmal atrial fibrillation (AF) in ischemic stroke patients who have a presumed known stroke etiology other than atrial fibrillation.</description>
        <time_frame>1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>NonCryptogenic Ischemic Stroke</title>
            <description>Reveal LINQ Insertable Cardiac Monitor</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Paroxysmal Atrial Fibrillation (AF) in Ischemic Stroke Patients</title>
          <description>The incidence of paroxysmal atrial fibrillation (AF) in ischemic stroke patients who have a presumed known stroke etiology other than atrial fibrillation.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patients Who Are Diagnosed With AF Who Are Changed to Anticoagulant Therapy.</title>
        <description>Percentage of patients who are diagnosed with AF who are changed to anticoagulant therapy.</description>
        <time_frame>1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>NonCryptogenic Ischemic Stroke Patients</title>
            <description>In this pilot prospective cohort study of non-CIS patients from September 2014 to September 2017, 53 patients were enrolled. 51/53 patients were implanted within 10 days of stroke onset with the Reveal LINQ insertable cardiac monitor and monitored until PAF detection or a minimum of 12 months. Inclusion required diagnosis of a non-AF stroke etiology, age≥40, and either a virtual CHADS2 score ≥3 or ≥2 PAF related comorbidities.</description>
          </group>
        </group_list>
        <measure>
          <title>Patients Who Are Diagnosed With AF Who Are Changed to Anticoagulant Therapy.</title>
          <description>Percentage of patients who are diagnosed with AF who are changed to anticoagulant therapy.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of AF Episodes.</title>
        <description>Duration of AF episodes (mean and range).</description>
        <time_frame>1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>NonCryptogenic Ischemic Stroke Patients</title>
            <description>In this pilot prospective cohort study of non-CIS patients from September 2014 to September 2017, 53 patients were enrolled. 51/53 patients were implanted within 10 days of stroke onset with the Reveal LINQ insertable cardiac monitor and monitored until PAF detection or a minimum of 12 months. Inclusion required diagnosis of a non-AF stroke etiology, age≥40, and either a virtual CHADS2 score ≥3 or ≥2 PAF related comorbidities.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of AF Episodes.</title>
          <description>Duration of AF episodes (mean and range).</description>
          <units>min</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="237" lower_limit="1" upper_limit="1122"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Asymptomatic AF</title>
        <description>Percentage of asymptomatic AF episodes.</description>
        <time_frame>1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>NonCryptogenic Ischemic Stroke Patients</title>
            <description>Reveal LINQ Insertable Cardiac Monitor.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Asymptomatic AF</title>
          <description>Percentage of asymptomatic AF episodes.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence of Recurrent Stroke</title>
        <description>Incidence of recurrent ischemic stroke.</description>
        <time_frame>1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>NonCryptogenic Ischemic Stroke Patients</title>
            <description>Reveal LINQ Insertable Cardiac Monitor.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Recurrent Stroke</title>
          <description>Incidence of recurrent ischemic stroke.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients That Had Multiple AF Episodes</title>
        <description>Number of patients that had multiple AF episodes.</description>
        <time_frame>1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>NonCryptogenic Ischemic Stroke</title>
            <description>Reveal LINQ Insertable Cardiac Monitor</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients That Had Multiple AF Episodes</title>
          <description>Number of patients that had multiple AF episodes.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>3 years</time_frame>
      <group_list>
        <group group_id="E1">
          <title>NonCryptogenic Ischemic Stroke Patients</title>
          <description>Reveal LINQ Insertable Cardiac Monitor</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Device Erosion</sub_title>
                <description>1 patient had a complication of impending device erosion through the skin. Managed with antibiotics and device removal.</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Relatively small sample size limits our study's power to detect and confirm all factors associated with PAF detection. The number of non-PAF patients lost to follow-up by 6 and 12 months that may have resulted in an underestimation of PAF burden.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Jeffrey M. Katz</name_or_title>
      <organization>Northwell Health</organization>
      <phone>516-562-3062</phone>
      <email>jkatz2@northwell.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02232022
org study id: 14-336
nct id: NCT02232022
lead sponsor: 
has dmc: Yes
The purpose of this study is to determine the incidence of paroxysmal atrial fibrillation
      (AF) in ischemic stroke patients who have a presumed known stroke etiology other than atrial
      fibrillation.
Recent studies suggest that their is a relatively high incidence of silent paroxysmal atrial
      fibrillation (PAF) in cryptogenic ischemic stroke patients. Detection of silent PAF in this
      population, however, requires prolonged cardiac monitoring. On the other hand, there is no
      understanding of the frequency of silent PAF in patients with a "known" or presumed etiology
      for their ischemic stroke other than AF. If this incidence is also found to be significant, a
      dramatic change in stroke evaluation and management would likely occur. This study intends to
      find the incidence of PAF in a population of recent (within 7 days) ischemic stroke patients
      (or MRI positive "transient ischemic attack (TIA)" patients) who have presumed etiology for
      their stroke other than atrial fibrillation or other high risk cardiac lesion. Stroke
      etiology will be determined through a standard post-stroke evaluation that includes:

        -  Brain MRI

        -  12-lead electrocardiogram (ECG) for AF detection

        -  24-h ECG monitoring for AF detection (eg, Holter monitor or cardiac telemetry)

        -  Transthoracic and/or Transesophageal echocardiogram

        -  CT or MR angiography of the head and neck

        -  Hypercoagulable blood panel for patients less than 55 years-old. Preliminary
           hypercoagulable work-up within 7 days will include the antiphospholipid antibody
           syndrome results, which will be needed to determine stroke management. All other
           results, which could take longer to return, including genetic tests of
           hypercoagulability, rarely change stroke management.

      To find occult PAF in this population, participants will have an insertable cardiac monitor
      (Reveal LINQ ICM) implanted within 7 days of the incident stroke and will be monitored for at
      least 1 year.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Incidence of Paroxysmal Atrial Fibrillation (AF) in Ischemic Stroke Patients
time frame: 1 year
description: The incidence of paroxysmal atrial fibrillation (AF) in ischemic stroke patients who have a presumed known stroke etiology other than atrial fibrillation.
measure: Patients Who Are Diagnosed With AF Who Are Changed to Anticoagulant Therapy.
time frame: 1 year
description: Percentage of patients who are diagnosed with AF who are changed to anticoagulant therapy.
measure: Duration of AF Episodes.
time frame: 1 year
description: Duration of AF episodes (mean and range).
measure: Percentage of Asymptomatic AF
time frame: 1 year
description: Percentage of asymptomatic AF episodes.
measure: Incidence of Recurrent Stroke
time frame: 1 year
description: Incidence of recurrent ischemic stroke.
measure: Number of Patients That Had Multiple AF Episodes
time frame: 1 year
description: Number of patients that had multiple AF episodes.
arm group label: NonCryptogenic Ischemic Stroke Patients
arm group type: Experimental
description: Patients with non-cryptogenic ischemic stroke will be enrolled within 10 days of stroke onset
intervention type: Device
intervention name: Reveal LINQ Insertable Cardiac Monitor
arm group label: NonCryptogenic Ischemic Stroke Patients
criteria: 
gender: All
minimum age: 41 Years
maximum age: N/A
healthy volunteers: No
last name: Jeffrey M. Katz, MD
role: Principal Investigator
affiliation: Northwell Health
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Northwell Health
investigator full name: Jeffrey Katz
investigator title: Chief, Vascular Neurology
mesh term: Stroke
mesh term: Ischemic Stroke
mesh term: Cerebral Infarction
mesh term: Atrial Fibrillation
mesh term: Ischemia
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Relatively small sample size limits our study's power to detect and confirm all factors associated with PAF detection. The number of non-PAF patients lost to follow-up by 6 and 12 months that may have resulted in an underestimation of PAF burden.
point of contact: 