<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/NCT03836339</url>
  </required_header>
  <id_info>
    <org_study_id>2018ACFA10-11</org_study_id>
    <nct_id>NCT03836339</nct_id>
  </id_info>
  <brief_title>Assessment of Atrial Fibrillation in Emergency Department</brief_title>
  <acronym>ACFA</acronym>
  <official_title>Appréciation de la Prise en Charge de la Fibrillation Atriale Aux Urgences</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RESCUe - RESeau Cardiologie Urgence / RESUVal - RESeau des Urgences de la vallée du Rhône</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>French Cardiology Society</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>French Society of Emergency Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Bayer</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>RESCUe - RESeau Cardiologie Urgence / RESUVal - RESeau des Urgences de la vallée du Rhône</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>
      Atrial Fibrillation (AF) is the most common disorder of the rhythm disturbance, especially in&#xD;
      older adults. The incidence and prevalence of AF increases significantly with age: less than&#xD;
      one new case per 1000/year before age 40 to 20/1000 per year after the age of eighty. AF&#xD;
      represents 1% of emergency department (ED) visits a third of which are inaugural or&#xD;
      recurrent. The causes are varied from cardiac (ischemic cardiac disease, valvular, high blood&#xD;
      pressure, heart failure, pericarditis, myocarditis) to extra cardiac etiologies (pulmonary&#xD;
      embolism, thyroid disorders, thyrotoxicosis, alcohol, shock, chest trauma, electrolyte&#xD;
      disorders, dehydration). While the diagnosis is given quickly by reading the&#xD;
      electrocardiogram (ECG), its management both in terms of therapeutic strategy that of choice&#xD;
      of care pathway is complex as evidenced by the diversity of possibilities and the difference&#xD;
      in practice. Specific recommendations have been published by the French Society of Emergency&#xD;
      Medicine in 2015. Our study aims to investigate guidelines implementation in French ED,&#xD;
      especially the contribution of diagnostic tests and initiated treatments. Therapeutic&#xD;
      strategies are evaluated with a follow up at 3 months, 6 months and 1 year, reporting&#xD;
      cardiovascular events and long-term treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is non-interventional, recruiting patients presenting to ED with AF. No other&#xD;
      epidemiological studies on the subject are available to calculate the required number of&#xD;
      subjects and analyze the power of the study. Investigators planned to include 1 575 patients&#xD;
      (45 patients in 35 centres) with a minimum targeted 1000 patients to be included in the 30-40&#xD;
      participating centers. The study aims to assess patients characteristics (age, sex, body mass&#xD;
      index, type of AF, Congestive Heart failure Hypertension Age Diabetes Stroke - VAscular&#xD;
      disease (CHA2DS2- VAsc) Score, Hypertension Abnormal liver/renal function, Stroke history,&#xD;
      Bleeding history or predisposition, Labile INR, Elderly, Drug/alcohol usage (HAS-BLED)&#xD;
      score), methods of diagnostic (blood tests, ECG, Imaging tests, Cardiac echography),&#xD;
      treatment pattern (drugs administered in ED, drug prescribed at hospitalization discharge),&#xD;
      patient pathway (orientation after ED admission, discharge, consultation planned),&#xD;
      drug-related observance reported by the patient.&#xD;
&#xD;
      Data are collected in a case report form (CRF). Source data verification is performed by&#xD;
      sites investigators. A data dictionary containing detailed descriptions of each variable is&#xD;
      shared with investigators. Sites monitoring is planned by a clinical research assistant for&#xD;
      completing missing data.&#xD;
&#xD;
      Statistical analysis: Data are medians and interquartile ranges (IQRs) for continuous&#xD;
      variables, and numbers and percentages for qualitative variables. Stratified analysis of&#xD;
      subgroups (age, sex, anticoagulant treatment, examination performed …) will be considered.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2018</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>atrial fibrillation type</measure>
    <time_frame>At admission</time_frame>
    <description>Number of idiopathic AF, AF secondary to acute heart failure, pulmonary embolism, COPD decompensation, pneumopathy, dysthyroidism, or any other precipitating factor.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Troponin value</measure>
    <time_frame>At admission</time_frame>
    <description>incidence of positive troponin</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Brain Natriuretic Peptide (BNP/proBNP) value</measure>
    <time_frame>At admission</time_frame>
    <description>incidence of BNP elevation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Renal Clearance</measure>
    <time_frame>At admission</time_frame>
    <description>Renal clerance(Cl) measuring (by Cockroft formula : Cl(Male) = 1,23 x Weight (kg) x (140 - Age)/Creatinine, Cl(Female) = 1,04 x Weight (kg) x (140 - Age)/Creatinine)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>cardiac echography</measure>
    <time_frame>At admission</time_frame>
    <description>number of cardiac echography performed in ED</description>
  </primary_outcome>
  <primary_outcome>
    <measure>antiarythmic drugs</measure>
    <time_frame>at admission</time_frame>
    <description>list antiarythmic drugs administration (Class IA, IB, IC, II, III or IV of Vaughan Williams classification, digitalis or adenosin)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>antiarythmic drugs</measure>
    <time_frame>at 3 months</time_frame>
    <description>list antiarythmic drugs administration (Class IA, IB, IC, II, III or IV of Vaughan Williams classification, digitalis or adenosin)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>antiarythmic drugs</measure>
    <time_frame>at 6 months</time_frame>
    <description>list antiarythmic drugs administration (Class IA, IB, IC, II, III or IV of Vaughan Williams classification, digitalis or adenosin)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>antiarythmic drugs</measure>
    <time_frame>at 1 year</time_frame>
    <description>list antiarythmic drugs administration (Class IA, IB, IC, II, III or IV of Vaughan Williams classification, digitalis or adenosin)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>anticoagulant strategy</measure>
    <time_frame>at admission</time_frame>
    <description>anticoagulant therapy (vitamin K antagonist or direct oral anticoagulant) administration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>anticoagulant strategy</measure>
    <time_frame>at 3 months, 6 months and 1 year</time_frame>
    <description>anticoagulant therapy (vitamin K antagonist or direct oral anticoagulant) administration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>anticoagulant strategy</measure>
    <time_frame>at 6 months and 1 year</time_frame>
    <description>anticoagulant therapy (vitamin K antagonist or direct oral anticoagulant) administration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>anticoagulant strategy</measure>
    <time_frame>at 1 year</time_frame>
    <description>anticoagulant therapy (vitamin K antagonist or direct oral anticoagulant) administration</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>mortality</measure>
    <time_frame>at 24 hours after admission</time_frame>
    <description>number of dead patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mortality</measure>
    <time_frame>at 3 months</time_frame>
    <description>number of dead patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mortality</measure>
    <time_frame>at 6 months</time_frame>
    <description>number of dead patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mortality</measure>
    <time_frame>at 1 year</time_frame>
    <description>number of dead patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>atrial fibrillation incidence</measure>
    <time_frame>at 3 months</time_frame>
    <description>number of patients with recurrent and persistent</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>atrial fibrillation incidence</measure>
    <time_frame>at 6 months</time_frame>
    <description>number of patients with recurrent and persistent</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>atrial fibrillation incidence</measure>
    <time_frame>at 1 year</time_frame>
    <description>number of patients with recurrent and persistent</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>stroke incidence</measure>
    <time_frame>at admission</time_frame>
    <description>number of new strokes occured</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>stroke incidence</measure>
    <time_frame>at 3 months</time_frame>
    <description>number of new strokes occured</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>stroke incidence</measure>
    <time_frame>at 6 months</time_frame>
    <description>number of new strokes occured</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>stroke incidence</measure>
    <time_frame>at 1 year</time_frame>
    <description>number of new strokes occured</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>myocardial infarction incidence</measure>
    <time_frame>at admission</time_frame>
    <description>number of new myocardial infarctions occured</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>myocardial infarction incidence</measure>
    <time_frame>at 3 months</time_frame>
    <description>number of new myocardial infarctions occured</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>myocardial infarction incidence</measure>
    <time_frame>at 6 months</time_frame>
    <description>number of new myocardial infarctions occured</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>myocardial infarction incidence</measure>
    <time_frame>at 1 year</time_frame>
    <description>number of new myocardial infarctions occured</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hemorrhagic events</measure>
    <time_frame>at admission</time_frame>
    <description>type 1, 2 or 3 of the International Society on Thrombosis and Hemostasis classification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hemorrhagic events</measure>
    <time_frame>at 3 months</time_frame>
    <description>type 1, 2 or 3 of the International Society on Thrombosis and Hemostasis classification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hemorrhagic events</measure>
    <time_frame>at 6 months</time_frame>
    <description>type 1, 2 or 3 of the International Society on Thrombosis and Hemostasis classification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hemorrhagic events</measure>
    <time_frame>at 1 year</time_frame>
    <description>type 1, 2 or 3 of the International Society on Thrombosis and Hemostasis classification</description>
  </secondary_outcome>
  <enrollment type="Actual">1369</enrollment>
  <condition>Atrial Fibrillation</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All patients over 18 years admitted to the emergency department with an AF diagnosis on ECG&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Atrial fibrillation diagnosis on ECG&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal of the patient to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stephane Manzo-Silberman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>French Cardiology Society</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lucien Hussel Hospital</name>
      <address>
        <city>Vienne</city>
        <zip>38209</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>January 27, 2019</study_first_submitted>
  <study_first_submitted_qc>February 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 11, 2019</study_first_posted>
  <last_update_submitted>May 13, 2021</last_update_submitted>
  <last_update_submitted_qc>May 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>emergency department</keyword>
  <keyword>pathway of care</keyword>
  <keyword>assessment</keyword>
  <keyword>anticoagulants</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT03836339
org study id: 2018ACFA10-11
nct id: NCT03836339
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Atrial Fibrillation (AF) is the most common disorder of the rhythm disturbance, especially in
      older adults. The incidence and prevalence of AF increases significantly with age: less than
      one new case per 1000/year before age 40 to 20/1000 per year after the age of eighty. AF
      represents 1% of emergency department (ED) visits a third of which are inaugural or
      recurrent. The causes are varied from cardiac (ischemic cardiac disease, valvular, high blood
      pressure, heart failure, pericarditis, myocarditis) to extra cardiac etiologies (pulmonary
      embolism, thyroid disorders, thyrotoxicosis, alcohol, shock, chest trauma, electrolyte
      disorders, dehydration). While the diagnosis is given quickly by reading the
      electrocardiogram (ECG), its management both in terms of therapeutic strategy that of choice
      of care pathway is complex as evidenced by the diversity of possibilities and the difference
      in practice. Specific recommendations have been published by the French Society of Emergency
      Medicine in 2015. Our study aims to investigate guidelines implementation in French ED,
      especially the contribution of diagnostic tests and initiated treatments. Therapeutic
      strategies are evaluated with a follow up at 3 months, 6 months and 1 year, reporting
      cardiovascular events and long-term treatment.
This study is non-interventional, recruiting patients presenting to ED with AF. No other
      epidemiological studies on the subject are available to calculate the required number of
      subjects and analyze the power of the study. Investigators planned to include 1 575 patients
      (45 patients in 35 centres) with a minimum targeted 1000 patients to be included in the 30-40
      participating centers. The study aims to assess patients characteristics (age, sex, body mass
      index, type of AF, Congestive Heart failure Hypertension Age Diabetes Stroke - VAscular
      disease (CHA2DS2- VAsc) Score, Hypertension Abnormal liver/renal function, Stroke history,
      Bleeding history or predisposition, Labile INR, Elderly, Drug/alcohol usage (HAS-BLED)
      score), methods of diagnostic (blood tests, ECG, Imaging tests, Cardiac echography),
      treatment pattern (drugs administered in ED, drug prescribed at hospitalization discharge),
      patient pathway (orientation after ED admission, discharge, consultation planned),
      drug-related observance reported by the patient.

      Data are collected in a case report form (CRF). Source data verification is performed by
      sites investigators. A data dictionary containing detailed descriptions of each variable is
      shared with investigators. Sites monitoring is planned by a clinical research assistant for
      completing missing data.

      Statistical analysis: Data are medians and interquartile ranges (IQRs) for continuous
      variables, and numbers and percentages for qualitative variables. Stratified analysis of
      subgroups (age, sex, anticoagulant treatment, examination performed …) will be considered.
observational model: Cohort
time perspective: Prospective
measure: atrial fibrillation type
time frame: At admission
description: Number of idiopathic AF, AF secondary to acute heart failure, pulmonary embolism, COPD decompensation, pneumopathy, dysthyroidism, or any other precipitating factor.
measure: Troponin value
time frame: At admission
description: incidence of positive troponin
measure: Brain Natriuretic Peptide (BNP/proBNP) value
time frame: At admission
description: incidence of BNP elevation
measure: Renal Clearance
time frame: At admission
description: Renal clerance(Cl) measuring (by Cockroft formula : Cl(Male) = 1,23 x Weight (kg) x (140 - Age)/Creatinine, Cl(Female) = 1,04 x Weight (kg) x (140 - Age)/Creatinine)
measure: cardiac echography
time frame: At admission
description: number of cardiac echography performed in ED
measure: antiarythmic drugs
time frame: at admission
description: list antiarythmic drugs administration (Class IA, IB, IC, II, III or IV of Vaughan Williams classification, digitalis or adenosin)
measure: antiarythmic drugs
time frame: at 3 months
description: list antiarythmic drugs administration (Class IA, IB, IC, II, III or IV of Vaughan Williams classification, digitalis or adenosin)
measure: antiarythmic drugs
time frame: at 6 months
description: list antiarythmic drugs administration (Class IA, IB, IC, II, III or IV of Vaughan Williams classification, digitalis or adenosin)
measure: antiarythmic drugs
time frame: at 1 year
description: list antiarythmic drugs administration (Class IA, IB, IC, II, III or IV of Vaughan Williams classification, digitalis or adenosin)
measure: anticoagulant strategy
time frame: at admission
description: anticoagulant therapy (vitamin K antagonist or direct oral anticoagulant) administration
measure: anticoagulant strategy
time frame: at 3 months, 6 months and 1 year
description: anticoagulant therapy (vitamin K antagonist or direct oral anticoagulant) administration
measure: anticoagulant strategy
time frame: at 6 months and 1 year
description: anticoagulant therapy (vitamin K antagonist or direct oral anticoagulant) administration
measure: anticoagulant strategy
time frame: at 1 year
description: anticoagulant therapy (vitamin K antagonist or direct oral anticoagulant) administration
measure: mortality
time frame: at 24 hours after admission
description: number of dead patients
measure: mortality
time frame: at 3 months
description: number of dead patients
measure: mortality
time frame: at 6 months
description: number of dead patients
measure: mortality
time frame: at 1 year
description: number of dead patients
measure: atrial fibrillation incidence
time frame: at 3 months
description: number of patients with recurrent and persistent
measure: atrial fibrillation incidence
time frame: at 6 months
description: number of patients with recurrent and persistent
measure: atrial fibrillation incidence
time frame: at 1 year
description: number of patients with recurrent and persistent
measure: stroke incidence
time frame: at admission
description: number of new strokes occured
measure: stroke incidence
time frame: at 3 months
description: number of new strokes occured
measure: stroke incidence
time frame: at 6 months
description: number of new strokes occured
measure: stroke incidence
time frame: at 1 year
description: number of new strokes occured
measure: myocardial infarction incidence
time frame: at admission
description: number of new myocardial infarctions occured
measure: myocardial infarction incidence
time frame: at 3 months
description: number of new myocardial infarctions occured
measure: myocardial infarction incidence
time frame: at 6 months
description: number of new myocardial infarctions occured
measure: myocardial infarction incidence
time frame: at 1 year
description: number of new myocardial infarctions occured
measure: hemorrhagic events
time frame: at admission
description: type 1, 2 or 3 of the International Society on Thrombosis and Hemostasis classification
measure: hemorrhagic events
time frame: at 3 months
description: type 1, 2 or 3 of the International Society on Thrombosis and Hemostasis classification
measure: hemorrhagic events
time frame: at 6 months
description: type 1, 2 or 3 of the International Society on Thrombosis and Hemostasis classification
measure: hemorrhagic events
time frame: at 1 year
description: type 1, 2 or 3 of the International Society on Thrombosis and Hemostasis classification
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stephane Manzo-Silberman, MD
role: Principal Investigator
affiliation: French Cardiology Society
facility: 
country: France
responsible party type: Sponsor
mesh term: Atrial Fibrillation