xml: <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/NCT05978388</url>
    </required_header>
    <id_info>
      <org_study_id>FIBCAG</org_study_id>
      <nct_id>NCT05978388</nct_id>
    </id_info>
    <brief_title>Coronary Computed Tomography AngioGraphy Prior to Catheter Ablation in Patients With Atrial FIBrillation</brief_title>
    <acronym>FIBCAG</acronym>
    <official_title>Coronary Computed Tomography AngioGraphy Prior to Catheter Ablation in Patients With Atrial FIBrillation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tor Biering-Sørensen</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Herlev and Gentofte Hospital</source>
    <oversight_info>
      <has_dmc>No</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>
        The purpose of this randomized, controlled trial is to investigate whether coronary computed&#xD;
        tomography (CT) angiography and derived treatment (medical anti-ischemic and multimodality&#xD;
        treatment and/or mechanical revascularization) prior to catheter ablation improve clinical&#xD;
        outcomes in patients with atrial fibrillation.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study is an investigator-initiated, prospective, randomized, unblinded, controlled trial&#xD;
        to investigate whether coronary CT angiography and derived treatment prior to catheter&#xD;
        ablation improves clinical outcomes in patients with atrial fibrillation. The study&#xD;
        population will consist of approximately 852 patients aged 18 years and above referred for a&#xD;
        catheter ablation treatment for atrial fibrillation at Gentofte Hospital in Denmark. All&#xD;
        participants included in the study will have a coronary CT angiography and coronary artery&#xD;
        calcium (CAC) scoring performed as an amendment to the standard CT scan of the heart for&#xD;
        mapping of the atria prior to catheter ablation. The participants are randomized 1:1 to&#xD;
        either have the coronary CT angiography analyzed or not prior to the catheter ablation.&#xD;
        According to the result of the coronary CT angiography in the intervention group, subsequent&#xD;
        actions may include intensified multimodality medical treatment or referral to invasive&#xD;
        coronary angiography and possibly mechanical revascularization according to clinical&#xD;
        guidelines. The study will be completed when every participant in the trial has been followed&#xD;
        for at least 1.5 years. The primary endpoint is time to first ECG-documented recurrence of&#xD;
        atrial fibrillation.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">April 1, 2028</completion_date>
    <primary_completion_date type="Anticipated">April 1, 2028</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Between-group difference in the time to first ECG-documented recurrence of atrial tachyarrhythmia after catheter ablation</measure>
      <time_frame>Up to 4.5 years</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Between-group difference in time to first documented occurrence of other arrhythmias after ablation</measure>
      <time_frame>Up to 4.5 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Between-group difference in the number of participants hospitalized for angina pectoris and acute coronary syndrome after ablation</measure>
      <time_frame>Up to 4.5 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Between-group difference in the incidence of acute myocardial infarction after ablation</measure>
      <time_frame>Up to 4.5 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Between-group difference in the number of patients undergoing revascularization procedures after ablation</measure>
      <time_frame>Up to 4.5 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Between-group difference in the number of deaths due to cardiovascular disease after ablation</measure>
      <time_frame>Up to 4.5 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Between-group difference in incidence of stroke after ablation</measure>
      <time_frame>Up to 4.5 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Between-group difference in incidence of heart failure or heart failure hospitalization after ablation</measure>
      <time_frame>Up to 4.5 years</time_frame>
    </secondary_outcome>
    <other_outcome>
      <measure>Between-group difference in the prevalence of coronary artery disease in patients with atrial fibrillation at baseline</measure>
      <time_frame>0</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Between group difference in the quality of life of participants as quantified by a validated self-administered questionnaire</measure>
      <time_frame>1.5 years</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>The proportion of participants in the active arm that are started or intensified on the following medication following the coronary CT angiography: statins, antithrombotic or antidiabetic medication</measure>
      <time_frame>1 month</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Between-group differences in the proportion of patients that are started or intensified on the following medication within 1 year after the coronary CT angiography: statins, antithrombotic, antidiabetic, or antihypertensive medication.</measure>
      <time_frame>1 year</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Between-group difference in the number of patients compliant with their prescribed medication 1 and 2 years after the coronary CT angiography as assessed based on a self-administered questionnaire</measure>
      <time_frame>2 years</time_frame>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">852</enrollment>
    <condition>Atrial Fibrillation</condition>
    <arm_group>
      <arm_group_label>Analysis of coronary CT angiography and CAC scoring prior to catheter ablation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Based on the results of the coronary CT angiography and CAC scoring in the intervention group, relevant anti-ischemic and multimodality treatment will be initiated according to clinical guidelines.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>No analysis of coronary CT angiography and CAC scoring prior to catheter ablation</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Patients in the control group will follow the current standard of care prior to ablation.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Analysis of coronary CT Angiography and CAC scoring prior to catheter ablation</intervention_name>
      <description>Analysis of coronary CT angiography and CAC scoring and derived treatment prior to catheter ablation.</description>
      <arm_group_label>Analysis of coronary CT angiography and CAC scoring prior to catheter ablation</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age over 18 years&#xD;
  &#xD;
            -  Referral for catheter ablation treatment (excluding AV-junction ablation) for atrial&#xD;
               fibrillation (all types of atrial fibrillation are included - paroxysmal, persistent,&#xD;
               long-term persistent and permanent) at the Department of Cardiology at Gentofte&#xD;
               Hospital. Both first ablation and re-ablation treatments are included.&#xD;
  &#xD;
            -  The ability and willingness to provide written informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Known atherosclerotic cardiovascular disease (ASCVD)&#xD;
  &#xD;
            -  Ongoing treatment with statins&#xD;
  &#xD;
            -  Contraindications for coronary CT angiography, e.g. contrast allergy&#xD;
  &#xD;
            -  Any surgical or medical condition, which in the opinion of the investigator, may place&#xD;
               the patient at higher risk from his/her participation in the study, or is likely to&#xD;
               prevent the patient from complying with the requirements of the study or completing&#xD;
               the study.&#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>Tor Biering-Sørensen, MD, PhD, MPH, MSc</last_name>
      <role>Study Chair</role>
      <affiliation>Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Caroline Espersen, MD</last_name>
      <phone>+4551180082</phone>
      <email>caroline.espersen@regionh.dk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Tor Biering-Sørensen, MD, PhD, MPH, MSc</last_name>
      <phone>+4528933590</phone>
      <email>tor.biering-soerensen@regionh.dk</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte</name>
        <address>
          <city>Hellerup</city>
          <state>Region Hovedstaden</state>
          <zip>2900</zip>
          <country>Denmark</country>
        </address>
      </facility>
      <contact>
        <last_name>Caroline Espersen, MD</last_name>
        <phone>+4551180082</phone>
        <email>caroline.espersen@regionh.dk</email>
      </contact>
      <contact_backup>
        <last_name>Tor Biering-Sørensen, MD, PhD, MPH, MSc</last_name>
        <phone>+4528933590</phone>
        <email>tor.biering-soerensen@regionh.dk</email>
      </contact_backup>
      <investigator>
        <last_name>Caroline Espersen, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Denmark</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Herlev and Gentofte Hospital</investigator_affiliation>
      <investigator_full_name>Tor Biering-Sørensen</investigator_full_name>
      <investigator_title>Sponsor</investigator_title>
    </responsible_party>
    <keyword>Coronary Artery Disease</keyword>
    <keyword>Coronary Computed Tomography Angiography</keyword>
    <keyword>Atrial Fibrillation</keyword>
    <keyword>Ischemic heart disease</keyword>
    <keyword>Catheter Ablation</keyword>
    <keyword>Atherosclerosis</keyword>
    <keyword>Cardiovascular Diseases</keyword>
    <keyword>Randomized Controlled Trial</keyword>
    <keyword>Statins</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Atrial Fibrillation</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Please contact the sponsor-investigator in case of any inquiries.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05978388
  org study id: FIBCAG
  nct id: NCT05978388
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this randomized, controlled trial is to investigate whether coronary computed
        tomography (CT) angiography and derived treatment (medical anti-ischemic and multimodality
        treatment and/or mechanical revascularization) prior to catheter ablation improve clinical
        outcomes in patients with atrial fibrillation.
  The study is an investigator-initiated, prospective, randomized, unblinded, controlled trial
        to investigate whether coronary CT angiography and derived treatment prior to catheter
        ablation improves clinical outcomes in patients with atrial fibrillation. The study
        population will consist of approximately 852 patients aged 18 years and above referred for a
        catheter ablation treatment for atrial fibrillation at Gentofte Hospital in Denmark. All
        participants included in the study will have a coronary CT angiography and coronary artery
        calcium (CAC) scoring performed as an amendment to the standard CT scan of the heart for
        mapping of the atria prior to catheter ablation. The participants are randomized 1:1 to
        either have the coronary CT angiography analyzed or not prior to the catheter ablation.
        According to the result of the coronary CT angiography in the intervention group, subsequent
        actions may include intensified multimodality medical treatment or referral to invasive
        coronary angiography and possibly mechanical revascularization according to clinical
        guidelines. The study will be completed when every participant in the trial has been followed
        for at least 1.5 years. The primary endpoint is time to first ECG-documented recurrence of
        atrial fibrillation.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Between-group difference in the time to first ECG-documented recurrence of atrial tachyarrhythmia after catheter ablation
  time frame: Up to 4.5 years
  measure: Between-group difference in time to first documented occurrence of other arrhythmias after ablation
  time frame: Up to 4.5 years
  measure: Between-group difference in the number of participants hospitalized for angina pectoris and acute coronary syndrome after ablation
  time frame: Up to 4.5 years
  measure: Between-group difference in the incidence of acute myocardial infarction after ablation
  time frame: Up to 4.5 years
  measure: Between-group difference in the number of patients undergoing revascularization procedures after ablation
  time frame: Up to 4.5 years
  measure: Between-group difference in the number of deaths due to cardiovascular disease after ablation
  time frame: Up to 4.5 years
  measure: Between-group difference in incidence of stroke after ablation
  time frame: Up to 4.5 years
  measure: Between-group difference in incidence of heart failure or heart failure hospitalization after ablation
  time frame: Up to 4.5 years
  measure: Between-group difference in the prevalence of coronary artery disease in patients with atrial fibrillation at baseline
  time frame: 0
  measure: Between group difference in the quality of life of participants as quantified by a validated self-administered questionnaire
  time frame: 1.5 years
  measure: The proportion of participants in the active arm that are started or intensified on the following medication following the coronary CT angiography: statins, antithrombotic or antidiabetic medication
  time frame: 1 month
  measure: Between-group differences in the proportion of patients that are started or intensified on the following medication within 1 year after the coronary CT angiography: statins, antithrombotic, antidiabetic, or antihypertensive medication.
  time frame: 1 year
  measure: Between-group difference in the number of patients compliant with their prescribed medication 1 and 2 years after the coronary CT angiography as assessed based on a self-administered questionnaire
  time frame: 2 years
  arm group label: Analysis of coronary CT angiography and CAC scoring prior to catheter ablation
  arm group type: Experimental
  description: Based on the results of the coronary CT angiography and CAC scoring in the intervention group, relevant anti-ischemic and multimodality treatment will be initiated according to clinical guidelines.
  arm group label: No analysis of coronary CT angiography and CAC scoring prior to catheter ablation
  arm group type: No Intervention
  description: Patients in the control group will follow the current standard of care prior to ablation.
  intervention type: Diagnostic Test
  intervention name: Analysis of coronary CT Angiography and CAC scoring prior to catheter ablation
  description: Analysis of coronary CT angiography and CAC scoring and derived treatment prior to catheter ablation.
  arm group label: Analysis of coronary CT angiography and CAC scoring prior to catheter ablation
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Tor Biering-Sørensen, MD, PhD, MPH, MSc
  role: Study Chair
  affiliation: Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
  last name: Caroline Espersen, MD
  phone: +4551180082
  email: caroline.espersen@regionh.dk
  last name: Tor Biering-Sørensen, MD, PhD, MPH, MSc
  phone: +4528933590
  email: tor.biering-soerensen@regionh.dk
  facility: 
  contact: 
  contact backup: 
  investigator: 
  country: Denmark
  responsible party type: Sponsor-Investigator
  investigator affiliation: Herlev and Gentofte Hospital
  investigator full name: Tor Biering-Sørensen
  investigator title: Sponsor
  mesh term: Atrial Fibrillation
  sharing ipd: Yes
  ipd description: Please contact the sponsor-investigator in case of any inquiries.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)