<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/NCT03007199</url>
  </required_header>
  <id_info>
    <org_study_id>CCMO # 13598</org_study_id>
    <nct_id>NCT03007199</nct_id>
  </id_info>
  <brief_title>Arrhythmia Genetics in the NEtherlandS</brief_title>
  <acronym>AGNES</acronym>
  <official_title>Arrhythmia Genetics in the NEtherlandS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The AGNES case-control set consists of individuals with a first acute ST-elevation myocardial&#xD;
      infarction. AGNES cases have ECG- registered ventricular fibrillation occurring before&#xD;
      reperfusion therapy for an acute and first ST-elevation myocardial infarction. AGNES controls&#xD;
      are individuals with a first acute ST-elevation myocardial infarction but without ventricular&#xD;
      fibrillation. All cases and controls are recruited at seven heart centers in The Netherlands.&#xD;
      The investigators' exclude individuals with an actual non-ST-elevation myocardial infarction,&#xD;
      prior myocardial infarction, congenital heart defects, known structural heart disease, severe&#xD;
      comorbidity, electrolyte disturbances, trauma at presentation, recent surgery, previous&#xD;
      coronary artery bypass graft or use of class I and III antiarrhythmic drugs. Individuals who&#xD;
      develop ventricular fibrillation during or after percutaneous coronary intervention are not&#xD;
      eligible. Furthermore, because early reperfusion limits the opportunity of developing&#xD;
      ventricular fibrillation, potential control subjects undergoing percutaneous coronary&#xD;
      intervention within 2 h after onset of myocardial ischemia symptoms were not included. This&#xD;
      time interval is based on the observation that &gt;90% of cases develop ventricular fibrillation&#xD;
      within 2 h after onset of the complaint of symptoms.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>February 2010</start_date>
  <primary_completion_date type="Anticipated">January 2018</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>Differences in genetic and inflammatory profile between cases and controls.</measure>
    <time_frame>Immediately upon admission, measures are based on samples taken at admission.</time_frame>
    <description>Differences in genetic profile and inflammatory profile between cases and controls are investigated between the complete cohorts.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Differences in clinical characteristics between cases and controls</measure>
    <time_frame>Immediately upon admission, measures are based on status at hospital admission.</time_frame>
    <description>Differences in clinical characteristics between cases and controls are investigated between the complete cohorts.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Previously described risk factors</measure>
    <time_frame>Immediately upon admission, measures are based on status at hospital admission.</time_frame>
    <description>Clinical characteristics that were previously described as possible risk factors for the development of VF (ventricular Fibrillation) during AMI (acute myocardial infarction): certain ECG characteristics, infarct size, infarct location, extent and localization of coronary disease. Are investigated for differences between cases and controls in the complete cohorts</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">2000</enrollment>
  <condition>Myocardial Infarction First</condition>
  <condition>Ventricular Fibrillation</condition>
  <arm_group>
    <arm_group_label>AGNES Controls</arm_group_label>
    <description>AGNES controls are individuals with a first acute ST-elevation myocardial infarction but without ventricular fibrillation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AGNES cases</arm_group_label>
    <description>AGNES cases have ECG- registered ventricular fibrillation occurring before reperfusion therapy for an acute and first ST-elevation myocardial infarction.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      DNA from blood.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Cases are patients with a first ST-elevation myocardial infarction (STEMI) referred for&#xD;
        primary percutaneous intervention (PCI), who develop ventricular fibrillation between the&#xD;
        onset of acute myocardial infarction (chest pain, ECG changes) and reperfusion. Reperfusion&#xD;
        can either be spontaneous or by PCI.&#xD;
&#xD;
        Control patients are patients with a first STEMI, referred for PCI who do not develop&#xD;
        ventricular fibrillation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. First ST elevation myocardial infarction (STEMI)&#xD;
&#xD;
          2. Between 18 and 80 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. A grandparent from non-European descent&#xD;
&#xD;
          2. Inborn errors; congenital heart defects.&#xD;
&#xD;
          3. Prior myocardial infarction (either STEMI or non-STEMI)&#xD;
&#xD;
          4. Previous CABG (coronary artery bypass graft)&#xD;
&#xD;
          5. Use of anti-arrhythmic drugs with the exception of beta-blockers, Ca2+-antagonists and&#xD;
             lanoxin.&#xD;
&#xD;
          6. Severe current co morbidity (electrolyte disturbances, K+&gt;5.5, K+&lt;3.0 mmol/L, anaemia,&#xD;
             trauma, surgery).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <reference>
    <citation>Marsman RF, Wilde AA, Bezzina CR. Genetic predisposition for sudden cardiac death in myocardial ischaemia: the Arrhythmia Genetics in the NEtherlandS study. Neth Heart J. 2011 Feb;19(2):96-100. doi: 10.1007/s12471-010-0070-4. Epub 2011 Jan 28.</citation>
    <PMID>21461030</PMID>
  </reference>
  <results_reference>
    <citation>Bezzina CR, Pazoki R, Bardai A, Marsman RF, de Jong JSSG, Blom MT, Scicluna BP, Jukema JW, Bindraban NR, Lichtner P, Pfeufer A, Bishopric NH, Roden DM, Meitinger T, Chugh SS, Myerburg RJ, Jouven X, Kaab S, Dekker LRC, Tan HL, Tanck MWT, Wilde AAM. Genome-wide association study identifies a susceptibility locus at 21q21 for ventricular fibrillation in acute myocardial infarction. Nat Genet. 2010 Aug;42(8):688-691. doi: 10.1038/ng.623. Epub 2010 Jul 11.</citation>
    <PMID>20622880</PMID>
  </results_reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 21, 2016</study_first_submitted>
  <study_first_submitted_qc>December 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>January 9, 2017</last_update_submitted>
  <last_update_submitted_qc>January 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</investigator_affiliation>
    <investigator_full_name>Connie Bezzina</investigator_full_name>
    <investigator_title>Prof. dr.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Ventricular Fibrillation</mesh_term>
    <mesh_term>Infarction</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/NCT03007199
org study id: CCMO # 13598
nct id: NCT03007199
lead sponsor: 
has dmc: No
The AGNES case-control set consists of individuals with a first acute ST-elevation myocardial
      infarction. AGNES cases have ECG- registered ventricular fibrillation occurring before
      reperfusion therapy for an acute and first ST-elevation myocardial infarction. AGNES controls
      are individuals with a first acute ST-elevation myocardial infarction but without ventricular
      fibrillation. All cases and controls are recruited at seven heart centers in The Netherlands.
      The investigators' exclude individuals with an actual non-ST-elevation myocardial infarction,
      prior myocardial infarction, congenital heart defects, known structural heart disease, severe
      comorbidity, electrolyte disturbances, trauma at presentation, recent surgery, previous
      coronary artery bypass graft or use of class I and III antiarrhythmic drugs. Individuals who
      develop ventricular fibrillation during or after percutaneous coronary intervention are not
      eligible. Furthermore, because early reperfusion limits the opportunity of developing
      ventricular fibrillation, potential control subjects undergoing percutaneous coronary
      intervention within 2 h after onset of myocardial ischemia symptoms were not included. This
      time interval is based on the observation that >90% of cases develop ventricular fibrillation
      within 2 h after onset of the complaint of symptoms.
observational model: Case-Control
time perspective: Prospective
measure: Differences in genetic and inflammatory profile between cases and controls.
time frame: Immediately upon admission, measures are based on samples taken at admission.
description: Differences in genetic profile and inflammatory profile between cases and controls are investigated between the complete cohorts.
measure: Differences in clinical characteristics between cases and controls
time frame: Immediately upon admission, measures are based on status at hospital admission.
description: Differences in clinical characteristics between cases and controls are investigated between the complete cohorts.
measure: Previously described risk factors
time frame: Immediately upon admission, measures are based on status at hospital admission.
description: Clinical characteristics that were previously described as possible risk factors for the development of VF (ventricular Fibrillation) during AMI (acute myocardial infarction): certain ECG characteristics, infarct size, infarct location, extent and localization of coronary disease. Are investigated for differences between cases and controls in the complete cohorts
arm group label: AGNES Controls
description: AGNES controls are individuals with a first acute ST-elevation myocardial infarction but without ventricular fibrillation.
arm group label: AGNES cases
description: AGNES cases have ECG- registered ventricular fibrillation occurring before reperfusion therapy for an acute and first ST-elevation myocardial infarction.
DNA from blood.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
citation: Marsman RF, Wilde AA, Bezzina CR. Genetic predisposition for sudden cardiac death in myocardial ischaemia: the Arrhythmia Genetics in the NEtherlandS study. Neth Heart J. 2011 Feb;19(2):96-100. doi: 10.1007/s12471-010-0070-4. Epub 2011 Jan 28.
PMID: 21461030
citation: Bezzina CR, Pazoki R, Bardai A, Marsman RF, de Jong JSSG, Blom MT, Scicluna BP, Jukema JW, Bindraban NR, Lichtner P, Pfeufer A, Bishopric NH, Roden DM, Meitinger T, Chugh SS, Myerburg RJ, Jouven X, Kaab S, Dekker LRC, Tan HL, Tanck MWT, Wilde AAM. Genome-wide association study identifies a susceptibility locus at 21q21 for ventricular fibrillation in acute myocardial infarction. Nat Genet. 2010 Aug;42(8):688-691. doi: 10.1038/ng.623. Epub 2010 Jul 11.
PMID: 20622880
responsible party type: Principal Investigator
investigator affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
investigator full name: Connie Bezzina
investigator title: Prof. dr.
mesh term: Myocardial Infarction
mesh term: Ventricular Fibrillation
mesh term: Infarction