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/NCT05973474</url>
    </required_header>
    <id_info>
      <org_study_id>SYSKY-2023-634-01</org_study_id>
      <nct_id>NCT05973474</nct_id>
    </id_info>
    <brief_title>The Atherogenic Index of Plasma（AIP） in Patients With Atrial Fibrillation</brief_title>
    <official_title>Prognostic Value of the Atherogenic Index of Plasma（AIP）for Cardiovascular Outcomes in Patients With Atrial Fibrillation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University</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 goal of this observational study is to learn about The Atherogenic Index of Plasma(AIP)&#xD;
        in patients with atrial fibrillation(AF). The main questions it aims to answer are: (1)To&#xD;
        investigate the correlation between AIP and the occurrence rate of AF. (2) To investigate the&#xD;
        correlation between AIP and the occurrence rate of cardiovascular outcome events (MACE&#xD;
        events, heart failure, embolism events) in patients with AF. Patients's clinical data&#xD;
        including medical history, laboratory tests, and imageological examination will be collected&#xD;
        and further analysed.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Baseline demographic data: age, gender, height, weight, systolic blood pressure, diastolic&#xD;
        blood pressure, smoking habit, drinking habit, physical activity, fasting blood glucose,&#xD;
        medication use (statins, ACEI/ARB, anticoagulant related drugs), basic medical history&#xD;
        (hypertension, diabetes mellitus, coronary heart disease).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">July 30, 2023</start_date>
    <completion_date type="Anticipated">July 2024</completion_date>
    <primary_completion_date type="Anticipated">March 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>atrial fibrillation (AF)</measure>
      <time_frame>10 years</time_frame>
      <description>AF diagnoses were ascertained by 3 different sources in our study: ECGs performed at study visits, hospital discharge codes, and death certificates. All ECGs automatically coded as AF were visually checked by a trained cardiologist to confirm AF diagnosis.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>major adverse cardiovascular events (MACEs)</measure>
      <time_frame>10 years</time_frame>
      <description>Follow up main adverse cardiovascular and cerebrovascular events such as death, myocardial infarction, stroke, and repeated revascularization.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>heart failure</measure>
      <time_frame>10 years</time_frame>
      <description>Patients who required intravenous medications for heart failure after admission (including diuretics, vasodilators, or inotropic agents) or a significant increase in the dose of oral diuretics (i.e., an increase in furosemide of ≥40mg or equivalent or the addition of a thiazide to a loop diuretic) were considered to have heart failure readmission. Pulmonary rales and/or the third heart sound, chest X-ray, dyspnea, peripheral edema, and NYHA grade were evaluated to further confirm the occurrence of heart failure.</description>
    </secondary_outcome>
    <enrollment type="Anticipated">5000</enrollment>
    <condition>Atrium; Fibrillation</condition>
    <condition>Lipid Metabolism Disorders</condition>
    <condition>Cardiovascular Diseases</condition>
    <condition>Event, Cardiac</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Patients diagnosed with AF during hospitalization in our hospital.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Atrial fibrillation was detected by electrocardiogram or 24-hour holter or portable&#xD;
               electrocardiogram monitor;&#xD;
  &#xD;
            2. age ≥18 years old;&#xD;
  &#xD;
            3. &quot;low-intermediate&quot; risk group of AF cardioembolic stroke: male patients with&#xD;
               CHA2DS2-VASc score 0-1 or female patients with CHA2DS2-VASc score 1-2&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. patients with rheumatic heart disease, congenital heart disease, cardiomyopathy,&#xD;
               hematological diseases, severe hepatic and renal insufficiency and connective tissue&#xD;
               diseases;&#xD;
  &#xD;
            2. Echocardiography showed valvular heart disease;&#xD;
  &#xD;
            3. patients with transient atrial fibrillation secondary to reversible causes:&#xD;
               hyperthyroidism, acute pulmonary embolism, recent surgery, acute myocardial&#xD;
               infarction, etc.&#xD;
  &#xD;
            4. severe carotid artery stenosis and intracranial artery stenosis;&#xD;
  &#xD;
            5. AF patients with recent major surgery.&#xD;
  &#xD;
            6. patients with serious lack of clinical data.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University</investigator_affiliation>
      <investigator_full_name>zhangkun</investigator_full_name>
      <investigator_title>associate chief physician</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Atrial Fibrillation</mesh_term>
      <mesh_term>Cardiovascular Diseases</mesh_term>
      <mesh_term>Metabolic Diseases</mesh_term>
      <mesh_term>Lipid Metabolism Disorders</mesh_term>
    </condition_browse>
    <!-- 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/NCT05973474
  org study id: SYSKY-2023-634-01
  nct id: NCT05973474
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study is to learn about The Atherogenic Index of Plasma(AIP)
        in patients with atrial fibrillation(AF). The main questions it aims to answer are: (1)To
        investigate the correlation between AIP and the occurrence rate of AF. (2) To investigate the
        correlation between AIP and the occurrence rate of cardiovascular outcome events (MACE
        events, heart failure, embolism events) in patients with AF. Patients's clinical data
        including medical history, laboratory tests, and imageological examination will be collected
        and further analysed.
  Baseline demographic data: age, gender, height, weight, systolic blood pressure, diastolic
        blood pressure, smoking habit, drinking habit, physical activity, fasting blood glucose,
        medication use (statins, ACEI/ARB, anticoagulant related drugs), basic medical history
        (hypertension, diabetes mellitus, coronary heart disease).
  observational model: Cohort
  time perspective: Retrospective
  measure: atrial fibrillation (AF)
  time frame: 10 years
  description: AF diagnoses were ascertained by 3 different sources in our study: ECGs performed at study visits, hospital discharge codes, and death certificates. All ECGs automatically coded as AF were visually checked by a trained cardiologist to confirm AF diagnosis.
  measure: major adverse cardiovascular events (MACEs)
  time frame: 10 years
  description: Follow up main adverse cardiovascular and cerebrovascular events such as death, myocardial infarction, stroke, and repeated revascularization.
  measure: heart failure
  time frame: 10 years
  description: Patients who required intravenous medications for heart failure after admission (including diuretics, vasodilators, or inotropic agents) or a significant increase in the dose of oral diuretics (i.e., an increase in furosemide of ≥40mg or equivalent or the addition of a thiazide to a loop diuretic) were considered to have heart failure readmission. Pulmonary rales and/or the third heart sound, chest X-ray, dyspnea, peripheral edema, and NYHA grade were evaluated to further confirm the occurrence of heart failure.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 85 Years
  healthy volunteers: Accepts Healthy Volunteers
  responsible party type: Principal Investigator
  investigator affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
  investigator full name: zhangkun
  investigator title: associate chief physician
  mesh term: Atrial Fibrillation
  mesh term: Cardiovascular Diseases
  mesh term: Metabolic Diseases
  mesh term: Lipid Metabolism Disorders